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Feasibility Trial of a Tailored Smoking Cessation App for People With Serious Mental Illness

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ClinicalTrials.gov Identifier: NCT03069482
Recruitment Status : Completed
First Posted : March 3, 2017
Results First Posted : March 23, 2020
Last Update Posted : November 10, 2020
Sponsor:
Collaborator:
National Institute on Drug Abuse (NIDA)
Information provided by (Responsible Party):
Duke University

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Conditions Nicotine Addiction
Serious Mental Illness
Interventions Device: Learn to Quit App
Drug: Nicotine patch
Drug: Nicotine lozenge
Behavioral: Technical Coaching
Device: NCI QuitGuide App
Enrollment 63
Recruitment Details  
Pre-assignment Details  
Arm/Group Title Learn to Quit NCI QuitGuide
Hide Arm/Group Description A smartphone app developed by the research team designed for people with serious mental illness, that provides Acceptance and Commitment Therapy skills to address (a) smoking cessation and (b) mental health symptoms. This app intervention is combined with an 8-week course of nicotine replacement therapy (NRT) patches and a 2-week course of NRT lozenges. Participants also receive technical smartphone coaching for the first 4 weeks of the study. A smartphone app developed by the National Cancer Institute which uses smoking cessation recommendations contained in the US DHHS Clinical Practice Guidelines. The app intervention is combined with an 8-week course of nicotine replacement therapy (NRT) patches and a 2-week course of NRT lozenges. Participants also receive technical smartphone coaching for the first 4 weeks of the study.
Period Title: Overall Study
Started 34 29
Completed 33 28
Not Completed 1 1
Reason Not Completed
Lost to Follow-up             0             1
Physician Decision             1             0
Arm/Group Title Learn to Quit NCI QuitGuide Total
Hide Arm/Group Description A smartphone app developed by the research team designed for people with serious mental illness, that provides Acceptance and Commitment Therapy skills to address (a) smoking cessation and (b) mental health symptoms. This app intervention is combined with an 8-week course of nicotine replacement therapy (NRT) patches and a 2-week course of NRT lozenges. Participants also receive technical smartphone coaching for the first 4 weeks of the study. A smartphone app developed by the National Cancer Institute which uses smoking cessation recommendations contained in the US DHHS Clinical Practice Guidelines. The app intervention is combined with an 8-week course of nicotine replacement therapy (NRT) patches and a 2-week course of NRT lozenges. Participants also receive technical smartphone coaching for the first 4 weeks of the study. Total of all reporting groups
Overall Number of Baseline Participants 33 29 62
Hide Baseline Analysis Population Description
One participant (Learn to Quit arm) was withdrawn by physician and therefore was not included in these analyses.
Age, Categorical  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 33 participants 29 participants 62 participants
<=18 years
0
   0.0%
0
   0.0%
0
   0.0%
Between 18 and 65 years
31
  93.9%
29
 100.0%
60
  96.8%
>=65 years
2
   6.1%
0
   0.0%
2
   3.2%
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 33 participants 29 participants 62 participants
48.4  (11.2) 45.6  (10.9) 47.1  (11.0)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 33 participants 29 participants 62 participants
Female
21
  63.6%
16
  55.2%
37
  59.7%
Male
12
  36.4%
13
  44.8%
25
  40.3%
Ethnicity (NIH/OMB)  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 33 participants 29 participants 62 participants
Hispanic or Latino
0
   0.0%
0
   0.0%
0
   0.0%
Not Hispanic or Latino
33
 100.0%
28
  96.6%
61
  98.4%
Unknown or Not Reported
0
   0.0%
1
   3.4%
1
   1.6%
Race (NIH/OMB)  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 33 participants 29 participants 62 participants
American Indian or Alaska Native
0
   0.0%
1
   3.4%
1
   1.6%
Asian
1
   3.0%
0
   0.0%
1
   1.6%
Native Hawaiian or Other Pacific Islander
0
   0.0%
0
   0.0%
0
   0.0%
Black or African American
14
  42.4%
11
  37.9%
25
  40.3%
White
16
  48.5%
16
  55.2%
32
  51.6%
More than one race
2
   6.1%
1
   3.4%
3
   4.8%
Unknown or Not Reported
0
   0.0%
0
   0.0%
0
   0.0%
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
United States Number Analyzed 33 participants 29 participants 62 participants
33 29 62
CPD at Baseline   [1] 
Mean (Standard Deviation)
Unit of measure:  Cigarettes per day
Number Analyzed 33 participants 29 participants 62 participants
21  (15.5) 14  (6.4) 17.9  (12.6)
[1]
Measure Description: Number of average cigarettes smoked per day at baseline.
MDD Diagnosis   [1] 
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 33 participants 29 participants 62 participants
8
  24.2%
9
  31.0%
17
  27.4%
[1]
Measure Description: Percentage of participant enrolled who had a diagnosis of recurrent major depressive disorder.
Bipolar Diagnosis   [1] 
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 33 participants 29 participants 62 participants
15
  45.5%
15
  51.7%
30
  48.4%
[1]
Measure Description: Percentage of participants enrolled who had diagnosis of bipolar I or II disorder.
Schizophrenia Spectrum Diagnosis   [1] 
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 33 participants 29 participants 62 participants
10
  30.3%
5
  17.2%
15
  24.2%
[1]
Measure Description: Percentage of participants enrolled who had a diagnosis of schizophrenia or schizoaffective disorder.
Education Levels   [1] 
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 33 participants 29 participants 62 participants
Secondary School or Less
11
  33.3%
10
  34.5%
21
  33.9%
Some College
9
  27.3%
8
  27.6%
17
  27.4%
Associate's Degree
4
  12.1%
5
  17.2%
9
  14.5%
Bachelor's Degree or Higher
9
  27.3%
6
  20.7%
15
  24.2%
[1]
Measure Description: The highest level of education by participants completed across groups.
Disability Status   [1] 
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 33 participants 29 participants 62 participants
19
  57.6%
9
  31.0%
28
  45.2%
[1]
Measure Description: Number of participants who self-reported to be on employment disability across groups.
Years of Smoking   [1] 
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 33 participants 29 participants 62 participants
25.6  (12.9) 26.8  (11.3) 26.2  (12.1)
[1]
Measure Description: Self-reported years of everyday smoking across groups
Nicotine Dependence   [1] 
Mean (Standard Deviation)
Unit of measure:  Units on a scale
Number Analyzed 33 participants 29 participants 62 participants
5.2  (2.6) 4.7  (2.3) 5.0  (2.5)
[1]
Measure Description: Nicotine dependence across groups as determined by the Fagerstrom Test for Nicotine Dependence. Scores range from 0 to 11 with higher scores indicating higher nicotine dependence.
Cognitive Functioning   [1] 
Mean (Full Range)
Unit of measure:  Units on a scale
Number Analyzed 33 participants 29 participants 62 participants
-1
(-3.73 to 1.66)
-0.9
(-5.19 to 1.20)
-0.95
(-5.19 to 1.66)
[1]
Measure Description: Cognitive functioning as assessed by the Brief Assessment of Cognition. Means are represented as Z-scores (lower scores = lower cognitive functioning, higher scores = higher cognitive functioning).
Household Income   [1] 
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 33 participants 29 participants 62 participants
<$35,000
24
  72.7%
18
  62.1%
42
  67.7%
$35-50,0000
4
  12.1%
2
   6.9%
6
   9.7%
$50-75,000
0
   0.0%
4
  13.8%
4
   6.5%
$75-100,000
1
   3.0%
1
   3.4%
2
   3.2%
>$100,000
4
  12.1%
4
  13.8%
8
  12.9%
[1]
Measure Description: Self-reported combined yearly income for all members living in the participants' households, across groups.
1.Primary Outcome
Title Days of App Use
Hide Description Frequency of app openings in each group
Time Frame Daily throughout study duration, 4 months
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Learn to Quit NCI QuitGuide
Hide Arm/Group Description:
A smartphone app developed by the research team designed for people with serious mental illness, that provides Acceptance and Commitment Therapy skills to address (a) smoking cessation and (b) mental health symptoms. This app intervention is combined with an 8-week course of nicotine replacement therapy (NRT) patches and a 2-week course of NRT lozenges. Participants also receive technical smartphone coaching for the first 4 weeks of the study.
A smartphone app developed by the National Cancer Institute which uses smoking cessation recommendations contained in the US DHHS Clinical Practice Guidelines. The app intervention is combined with an 8-week course of nicotine replacement therapy (NRT) patches and a 2-week course of NRT lozenges. Participants also receive technical smartphone coaching for the first 4 weeks of the study.
Overall Number of Participants Analyzed 33 29
Mean (Standard Deviation)
Unit of Measure: days
34.1  (27.7) 32  (24.5)
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Learn to Quit, NCI QuitGuide
Comments [Not Specified]
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value =0.754
Comments [Not Specified]
Method ANOVA
Comments [Not Specified]
Method of Estimation Estimation Parameter Slope
Estimated Value 1.063
Parameter Dispersion
Type: Standard Deviation
Value: 3.377
Estimation Comments [Not Specified]
2.Primary Outcome
Title Duration of App Use
Hide Description Mean duration of app use in each group over the course of study participation (4 months)
Time Frame Daily throughout study duration, 4 months
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Learn to Quit NCI QuitGuide
Hide Arm/Group Description:
A smartphone app developed by the research team designed for people with serious mental illness, that provides Acceptance and Commitment Therapy skills to address (a) smoking cessation and (b) mental health symptoms. This app intervention is combined with an 8-week course of nicotine replacement therapy (NRT) patches and a 2-week course of NRT lozenges. Participants also receive technical smartphone coaching for the first 4 weeks of the study.
A smartphone app developed by the National Cancer Institute which uses smoking cessation recommendations contained in the US DHHS Clinical Practice Guidelines. The app intervention is combined with an 8-week course of nicotine replacement therapy (NRT) patches and a 2-week course of NRT lozenges. Participants also receive technical smartphone coaching for the first 4 weeks of the study.
Overall Number of Participants Analyzed 33 29
Mean (Standard Deviation)
Unit of Measure: hours
4.24  (4.29) 2.14  (1.72)
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Learn to Quit, NCI QuitGuide
Comments [Not Specified]
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.044
Comments [Not Specified]
Method Mixed Models Analysis
Comments Zero inflated negative binomial mixed methods regression.
Method of Estimation Estimation Parameter Risk Ratio (RR)
Estimated Value 2.103
Confidence Interval (2-Sided) 095%
1.2 to 2.6
Parameter Dispersion
Type: Standard Deviation
Value: 0.369
Estimation Comments [Not Specified]
3.Primary Outcome
Title Feasibility as Measured by Study Accrual Relative to Recruitment Goal
Hide Description Percent of subjects consented into study relative to study recruitment goal (N=90).92 subjects signed consent prior to eligibility determination and randomization.
Time Frame Approximately 15 months
Hide Outcome Measure Data
Hide Analysis Population Description
The number of participants analyzed in this sample is larger than the number of participants who were ultimately randomized to the study as reflected in the participant flow section. This sample includes all participants who were consented into the study regardless of their final eligibility status prior to randomization.
Arm/Group Title All Consented Participants
Hide Arm/Group Description:
All participants consented to the study prior to eligibility determination.
Overall Number of Participants Analyzed 92
Measure Type: Number
Unit of Measure: percentage of target accrual
102
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection All Consented Participants
Comments [Not Specified]
Type of Statistical Test Other
Comments [Not Specified]
Method of Estimation Estimation Parameter Percent accrual relative to target N
Estimated Value 102
Estimation Comments [Not Specified]
Other Statistical Analysis The goal of this outcome was to determine whether the trial could reach its enrollment target (90 participants).
4.Primary Outcome
Title Feasibility as Measured by Study Attrition
Hide Description Number and percentage of subjects who complete 4-month follow up assessment
Time Frame 4-months
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Learn to Quit NCI QuitGuide
Hide Arm/Group Description:
A smartphone app developed by the research team designed for people with serious mental illness, that provides Acceptance and Commitment Therapy skills to address (a) smoking cessation and (b) mental health symptoms. This app intervention is combined with an 8-week course of nicotine replacement therapy (NRT) patches and a 2-week course of NRT lozenges. Participants also receive technical smartphone coaching for the first 4 weeks of the study.
A smartphone app developed by the National Cancer Institute which uses smoking cessation recommendations contained in the US DHHS Clinical Practice Guidelines. The app intervention is combined with an 8-week course of nicotine replacement therapy (NRT) patches and a 2-week course of NRT lozenges. Participants also receive technical smartphone coaching for the first 4 weeks of the study.
Overall Number of Participants Analyzed 33 29
Measure Type: Count of Participants
Unit of Measure: Participants
33
 100.0%
28
  96.6%
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Learn to Quit, NCI QuitGuide
Comments [Not Specified]
Type of Statistical Test Other
Comments [Not Specified]
Method of Estimation Estimation Parameter Percent retention relative to target
Estimated Value 98.3
Estimation Comments [Not Specified]
Other Statistical Analysis We calculated the percent of retained participants relative to the retention target (N = 62)
5.Primary Outcome
Title Recruitment Yield Effort
Hide Description Percent of subjects responding to ads and clinician referrals
Time Frame Approximately 15 months
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Total Patients in Database
Hide Arm/Group Description:
The total amount of patients who could have potentially contacted us or that we could have approached to participate in the study.
Overall Number of Participants Analyzed 499
Measure Type: Count of Participants
Unit of Measure: Participants
290
  58.1%
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Total Patients in Database
Comments [Not Specified]
Type of Statistical Test Other
Comments [Not Specified]
Method of Estimation Estimation Parameter Percent of respondents
Estimated Value 58
Estimation Comments [Not Specified]
6.Primary Outcome
Title Feasibility of Measurement Strategy
Hide Description Percent completion of assessment measures. Assessment measures include surveys, questionnaires, and cognitive tasks.
Time Frame Approximately 19 months
Hide Outcome Measure Data
Hide Analysis Population Description
Number of total possible assessment measures that could have been completed in each group.
Arm/Group Title Learn to Quit NCI QuitGuide
Hide Arm/Group Description:
A smartphone app developed by the research team designed for people with serious mental illness, that provides Acceptance and Commitment Therapy skills to address (a) smoking cessation and (b) mental health symptoms. This app intervention is combined with an 8-week course of nicotine replacement therapy (NRT) patches and a 2-week course of NRT lozenges. Participants also receive technical smartphone coaching for the first 4 weeks of the study.
A smartphone app developed by the National Cancer Institute which uses smoking cessation recommendations contained in the US DHHS Clinical Practice Guidelines. The app intervention is combined with an 8-week course of nicotine replacement therapy (NRT) patches and a 2-week course of NRT lozenges. Participants also receive technical smartphone coaching for the first 4 weeks of the study.
Overall Number of Participants Analyzed 33 29
Overall Number of Units Analyzed
Type of Units Analyzed: Assessments
1617 1421
Count of Units
Unit of Measure: assessments
1353
  83.7%
1284
  90.4%
7.Primary Outcome
Title Usability of App Design as Measured by the System Usability Scale (SUS)
Hide Description 10-item scale giving a global assessment of systems usability using a 5-point Likert Scale with a composite score ranging from 0-100. Higher scores indicate higher usability rating.
Time Frame 1-month follow-up
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Learn to Quit NCI QuitGuide
Hide Arm/Group Description:
A smartphone app developed by the research team designed for people with serious mental illness, that provides Acceptance and Commitment Therapy skills to address (a) smoking cessation and (b) mental health symptoms. This app intervention is combined with an 8-week course of nicotine replacement therapy (NRT) patches and a 2-week course of NRT lozenges. Participants also receive technical smartphone coaching for the first 4 weeks of the study.
A smartphone app developed by the National Cancer Institute which uses smoking cessation recommendations contained in the US DHHS Clinical Practice Guidelines. The app intervention is combined with an 8-week course of nicotine replacement therapy (NRT) patches and a 2-week course of NRT lozenges. Participants also receive technical smartphone coaching for the first 4 weeks of the study.
Overall Number of Participants Analyzed 33 29
Mean (Standard Deviation)
Unit of Measure: score on a scale
87.3  (13.6) 79.4  (15)
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Learn to Quit, NCI QuitGuide
Comments [Not Specified]
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.046
Comments [Not Specified]
Method Yuen's trimmed mean t-test
Comments [Not Specified]
Method of Estimation Estimation Parameter Trimmed mean difference
Estimated Value 8.29574
Confidence Interval (2-Sided) 95%
0.138 to 16.453
Parameter Dispersion
Type: Standard Error of the Mean
Value: 2.11
Estimation Comments [Not Specified]
8.Primary Outcome
Title Usability of App Design as Measured by the System Usability Scale (SUS)
Hide Description 10-item scale giving a global assessment of systems usability using a 5-point Likert Scale with a composite score ranging from 0-100. Higher scores indicate higher usability rating.
Time Frame 2-month follow-up
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Learn to Quit NCI QuitGuide
Hide Arm/Group Description:
A smartphone app developed by the research team designed for people with serious mental illness, that provides Acceptance and Commitment Therapy skills to address (a) smoking cessation and (b) mental health symptoms. This app intervention is combined with an 8-week course of nicotine replacement therapy (NRT) patches and a 2-week course of NRT lozenges. Participants also receive technical smartphone coaching for the first 4 weeks of the study.
A smartphone app developed by the National Cancer Institute which uses smoking cessation recommendations contained in the US DHHS Clinical Practice Guidelines. The app intervention is combined with an 8-week course of nicotine replacement therapy (NRT) patches and a 2-week course of NRT lozenges. Participants also receive technical smartphone coaching for the first 4 weeks of the study.
Overall Number of Participants Analyzed 33 29
Mean (Standard Deviation)
Unit of Measure: score on a scale
84.4  (13.5) 75.6  (19.6)
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Learn to Quit, NCI QuitGuide
Comments [Not Specified]
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.109
Comments [Not Specified]
Method Yuen's trimmed means t-test
Comments [Not Specified]
Method of Estimation Estimation Parameter Trimmed mean difference
Estimated Value 7.79514
Confidence Interval (2-Sided) 95%
-1.867 to 17.457
Parameter Dispersion
Type: Standard Error of the Mean
Value: 2.16
Estimation Comments [Not Specified]
9.Primary Outcome
Title Usability of App Design as Measured by the System Usability Scale (SUS)
Hide Description 10-item scale giving a global assessment of systems usability using a 5-point Likert Scale with a composite score ranging from 0-100. Higher scores indicate higher usability rating.
Time Frame 3-month follow-up
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Learn to Quit NCI QuitGuide
Hide Arm/Group Description:
A smartphone app developed by the research team designed for people with serious mental illness, that provides Acceptance and Commitment Therapy skills to address (a) smoking cessation and (b) mental health symptoms. This app intervention is combined with an 8-week course of nicotine replacement therapy (NRT) patches and a 2-week course of NRT lozenges. Participants also receive technical smartphone coaching for the first 4 weeks of the study.
A smartphone app developed by the National Cancer Institute which uses smoking cessation recommendations contained in the US DHHS Clinical Practice Guidelines. The app intervention is combined with an 8-week course of nicotine replacement therapy (NRT) patches and a 2-week course of NRT lozenges. Participants also receive technical smartphone coaching for the first 4 weeks of the study.
Overall Number of Participants Analyzed 33 29
Mean (Standard Deviation)
Unit of Measure: score on a scale
83.2  (14.1) 80.8  (15.6)
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Learn to Quit, NCI QuitGuide
Comments [Not Specified]
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.50537
Comments [Not Specified]
Method Yuen's trimmed means t-test
Comments [Not Specified]
Method of Estimation Estimation Parameter Trimmed mean difference
Estimated Value 2.22222
Confidence Interval (2-Sided) 95%
-4.492 to 8.943
Parameter Dispersion
Type: Standard Error of the Mean
Value: 1.75
Estimation Comments [Not Specified]
10.Primary Outcome
Title Usability of App Design as Measured by the System Usability Scale (SUS)
Hide Description 10-item scale giving a global assessment of systems usability using a 5-point Likert Scale with a composite score ranging from 0-100. Higher scores indicate higher usability rating.
Time Frame 4-month follow-up
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Learn to Quit NCI QuitGuide
Hide Arm/Group Description:
A smartphone app developed by the research team designed for people with serious mental illness, that provides Acceptance and Commitment Therapy skills to address (a) smoking cessation and (b) mental health symptoms. This app intervention is combined with an 8-week course of nicotine replacement therapy (NRT) patches and a 2-week course of NRT lozenges. Participants also receive technical smartphone coaching for the first 4 weeks of the study.
A smartphone app developed by the National Cancer Institute which uses smoking cessation recommendations contained in the US DHHS Clinical Practice Guidelines. The app intervention is combined with an 8-week course of nicotine replacement therapy (NRT) patches and a 2-week course of NRT lozenges. Participants also receive technical smartphone coaching for the first 4 weeks of the study.
Overall Number of Participants Analyzed 33 29
Mean (Standard Deviation)
Unit of Measure: score on a scale
85.2  (13.9) 78.7  (19.3)
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Learn to Quit, NCI QuitGuide
Comments [Not Specified]
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.27411
Comments [Not Specified]
Method Yuen's trimmed means t-test
Comments [Not Specified]
Method of Estimation Estimation Parameter Trimmed mean difference
Estimated Value 5.83333
Confidence Interval (2-Sided) 95%
-4.88 to 16.54
Parameter Dispersion
Type: Standard Error of the Mean
Value: 2.30
Estimation Comments [Not Specified]
11.Secondary Outcome
Title Biochemically Confirmed 7-day Point Prevalence Abstinence
Hide Description Percent of subjects in each group reporting biochemically confirmed 7-day point prevalence abstinence. Abstinence is determined by a self-report of not smoking for 7 days prior to the specified timepoint AND by a result of ≤ 5 ppm in carbon monoxide breath testing. If the participant does not meet both criteria, they are not considered abstinent.
Time Frame 1 month follow-up
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Learn to Quit NCI QuitGuide
Hide Arm/Group Description:
A smartphone app developed by the research team designed for people with serious mental illness, that provides Acceptance and Commitment Therapy skills to address (a) smoking cessation and (b) mental health symptoms. This app intervention is combined with an 8-week course of nicotine replacement therapy (NRT) patches and a 2-week course of NRT lozenges. Participants also receive technical smartphone coaching for the first 4 weeks of the study.
A smartphone app developed by the National Cancer Institute which uses smoking cessation recommendations contained in the US DHHS Clinical Practice Guidelines. The app intervention is combined with an 8-week course of nicotine replacement therapy (NRT) patches and a 2-week course of NRT lozenges. Participants also receive technical smartphone coaching for the first 4 weeks of the study.
Overall Number of Participants Analyzed 33 29
Measure Type: Count of Participants
Unit of Measure: Participants
3
   9.1%
5
  17.2%
12.Secondary Outcome
Title Biochemically Confirmed 7-day Point Prevalence Abstinence
Hide Description Percent of subjects in each group reporting biochemically confirmed 7-day point prevalence abstinence. Abstinence is determined by a self-report of not smoking for 7 days prior to the specified timepoint AND by a result of ≤ 5 ppm in carbon monoxide breath testing. If the participant does not meet both criteria, they are not considered abstinent.
Time Frame 2 month follow-up
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Learn to Quit NCI QuitGuide
Hide Arm/Group Description:
A smartphone app developed by the research team designed for people with serious mental illness, that provides Acceptance and Commitment Therapy skills to address (a) smoking cessation and (b) mental health symptoms. This app intervention is combined with an 8-week course of nicotine replacement therapy (NRT) patches and a 2-week course of NRT lozenges. Participants also receive technical smartphone coaching for the first 4 weeks of the study.
A smartphone app developed by the National Cancer Institute which uses smoking cessation recommendations contained in the US DHHS Clinical Practice Guidelines. The app intervention is combined with an 8-week course of nicotine replacement therapy (NRT) patches and a 2-week course of NRT lozenges. Participants also receive technical smartphone coaching for the first 4 weeks of the study.
Overall Number of Participants Analyzed 33 29
Measure Type: Count of Participants
Unit of Measure: Participants
6
  18.2%
0
   0.0%
13.Secondary Outcome
Title Biochemically Confirmed 7-day Point Prevalence Abstinence
Hide Description Percent of subjects in each group reporting biochemically confirmed 7-day point prevalence abstinence. Abstinence is determined by a self-report of not smoking for 7 days prior to the specified timepoint AND by a result of ≤ 5 ppm in carbon monoxide breath testing. If the participant does not meet both criteria, they are not considered abstinent.
Time Frame 3 month follow-up
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Learn to Quit NCI QuitGuide
Hide Arm/Group Description:
A smartphone app developed by the research team designed for people with serious mental illness, that provides Acceptance and Commitment Therapy skills to address (a) smoking cessation and (b) mental health symptoms. This app intervention is combined with an 8-week course of nicotine replacement therapy (NRT) patches and a 2-week course of NRT lozenges. Participants also receive technical smartphone coaching for the first 4 weeks of the study.
A smartphone app developed by the National Cancer Institute which uses smoking cessation recommendations contained in the US DHHS Clinical Practice Guidelines. The app intervention is combined with an 8-week course of nicotine replacement therapy (NRT) patches and a 2-week course of NRT lozenges. Participants also receive technical smartphone coaching for the first 4 weeks of the study.
Overall Number of Participants Analyzed 33 29
Measure Type: Count of Participants
Unit of Measure: Participants
3
   9.1%
2
   6.9%
14.Secondary Outcome
Title Biochemically Confirmed 7-day Point Prevalence Abstinence
Hide Description Percent of subjects in each group reporting biochemically confirmed 7-day point prevalence abstinence. Abstinence is determined by a self-report of not smoking for 7 days prior to the specified timepoint AND by a result of ≤ 5 ppm in carbon monoxide breath testing. If the participant does not meet both criteria, they are not considered abstinent.
Time Frame 4 month follow-up
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Learn to Quit NCI QuitGuide
Hide Arm/Group Description:
A smartphone app developed by the research team designed for people with serious mental illness, that provides Acceptance and Commitment Therapy skills to address (a) smoking cessation and (b) mental health symptoms. This app intervention is combined with an 8-week course of nicotine replacement therapy (NRT) patches and a 2-week course of NRT lozenges. Participants also receive technical smartphone coaching for the first 4 weeks of the study.
A smartphone app developed by the National Cancer Institute which uses smoking cessation recommendations contained in the US DHHS Clinical Practice Guidelines. The app intervention is combined with an 8-week course of nicotine replacement therapy (NRT) patches and a 2-week course of NRT lozenges. Participants also receive technical smartphone coaching for the first 4 weeks of the study.
Overall Number of Participants Analyzed 33 29
Measure Type: Count of Participants
Unit of Measure: Participants
4
  12.1%
1
   3.4%
15.Secondary Outcome
Title Biochemically Confirmed Prolonged Abstinence Rates
Hide Description Total number of participants in each group reporting prolonged abstinence at the specified time point. Abstinence is determined by a self-report of not relapsing after their quit date (i.e., not smoking for 7 consecutive days, or not smoking at least once each week for 2 consecutive weeks) following a 2-week grace period, AND by a result of ≤ 6 ppm in carbon monoxide breath testing. If the participant does not meet both criteria, they are not considered abstinent
Time Frame 1 month follow up
Hide Outcome Measure Data
Hide Analysis Population Description
A survey branching logic error led to incomplete data collection for this measure. Therefore, we could not collect data from all participants.
Arm/Group Title Learn to Quit NCI QuitGuide
Hide Arm/Group Description:
A smartphone app developed by the research team designed for people with serious mental illness, that provides Acceptance and Commitment Therapy skills to address (a) smoking cessation and (b) mental health symptoms. This app intervention is combined with an 8-week course of nicotine replacement therapy (NRT) patches and a 2-week course of NRT lozenges. Participants also receive technical smartphone coaching for the first 4 weeks of the study.
A smartphone app developed by the National Cancer Institute which uses smoking cessation recommendations contained in the US DHHS Clinical Practice Guidelines. The app intervention is combined with an 8-week course of nicotine replacement therapy (NRT) patches and a 2-week course of NRT lozenges. Participants also receive technical smartphone coaching for the first 4 weeks of the study.
Overall Number of Participants Analyzed 11 15
Measure Type: Count of Participants
Unit of Measure: Participants
4
  36.4%
3
  20.0%
16.Secondary Outcome
Title Biochemically Confirmed Prolonged Abstinence Rates
Hide Description Total number of participants in each group reporting prolonged abstinence at the specified time point. Abstinence is determined by a self-report of not relapsing after their quit date (i.e., not smoking for 7 consecutive days, or not smoking at least once each week for 2 consecutive weeks) following a 2-week grace period, AND by a result of ≤ 6 ppm in carbon monoxide breath testing. If the participant does not meet both criteria, they are not considered abstinent
Time Frame 2 month follow up
Hide Outcome Measure Data
Hide Analysis Population Description
A survey branching logic error led to incomplete data collection for this measure. Therefore, we could not collect data from all participants.
Arm/Group Title Learn to Quit NCI QuitGuide
Hide Arm/Group Description:
A smartphone app developed by the research team designed for people with serious mental illness, that provides Acceptance and Commitment Therapy skills to address (a) smoking cessation and (b) mental health symptoms. This app intervention is combined with an 8-week course of nicotine replacement therapy (NRT) patches and a 2-week course of NRT lozenges. Participants also receive technical smartphone coaching for the first 4 weeks of the study.
A smartphone app developed by the National Cancer Institute which uses smoking cessation recommendations contained in the US DHHS Clinical Practice Guidelines. The app intervention is combined with an 8-week course of nicotine replacement therapy (NRT) patches and a 2-week course of NRT lozenges. Participants also receive technical smartphone coaching for the first 4 weeks of the study.
Overall Number of Participants Analyzed 5 6
Measure Type: Count of Participants
Unit of Measure: Participants
0
   0.0%
0
   0.0%
17.Secondary Outcome
Title Biochemically Confirmed Prolonged Abstinence Rates
Hide Description Total number of participants in each group reporting prolonged abstinence at the specified time point. Abstinence is determined by a self-report of not relapsing after their quit date (i.e., not smoking for 7 consecutive days, or not smoking at least once each week for 2 consecutive weeks) following a 2-week grace period, AND by a result of ≤ 6 ppm in carbon monoxide breath testing. If the participant does not meet both criteria, they are not considered abstinent.
Time Frame 3 month follow up
Hide Outcome Measure Data
Hide Analysis Population Description
A survey branching logic error led to incomplete data collection for this measure. Therefore, we could not collect data from all participants.
Arm/Group Title Learn to Quit NCI QuitGuide
Hide Arm/Group Description:
A smartphone app developed by the research team designed for people with serious mental illness, that provides Acceptance and Commitment Therapy skills to address (a) smoking cessation and (b) mental health symptoms. This app intervention is combined with an 8-week course of nicotine replacement therapy (NRT) patches and a 2-week course of NRT lozenges. Participants also receive technical smartphone coaching for the first 4 weeks of the study.
A smartphone app developed by the National Cancer Institute which uses smoking cessation recommendations contained in the US DHHS Clinical Practice Guidelines. The app intervention is combined with an 8-week course of nicotine replacement therapy (NRT) patches and a 2-week course of NRT lozenges. Participants also receive technical smartphone coaching for the first 4 weeks of the study.
Overall Number of Participants Analyzed 6 3
Measure Type: Count of Participants
Unit of Measure: Participants
0
   0.0%
0
   0.0%
18.Secondary Outcome
Title Biochemically Confirmed Prolonged Abstinence Rates
Hide Description Total number of participants in each group reporting prolonged abstinence at the specified time point. Abstinence is determined by a self-report of not relapsing after their quit date (i.e., not smoking for 7 consecutive days, or not smoking at least once each week for 2 consecutive weeks) following a 2-week grace period, AND by a result of ≤ 6 ppm in carbon monoxide breath testing. If the participant does not meet both criteria, they are not considered abstinent.
Time Frame 4 month follow up
Hide Outcome Measure Data
Hide Analysis Population Description
A survey branching logic error led to incomplete data collection for this measure. Therefore, we could not collect data from all participants.
Arm/Group Title Learn to Quit NCI QuitGuide
Hide Arm/Group Description:
A smartphone app developed by the research team designed for people with serious mental illness, that provides Acceptance and Commitment Therapy skills to address (a) smoking cessation and (b) mental health symptoms. This app intervention is combined with an 8-week course of nicotine replacement therapy (NRT) patches and a 2-week course of NRT lozenges. Participants also receive technical smartphone coaching for the first 4 weeks of the study.
A smartphone app developed by the National Cancer Institute which uses smoking cessation recommendations contained in the US DHHS Clinical Practice Guidelines. The app intervention is combined with an 8-week course of nicotine replacement therapy (NRT) patches and a 2-week course of NRT lozenges. Participants also receive technical smartphone coaching for the first 4 weeks of the study.
Overall Number of Participants Analyzed 3 4
Measure Type: Count of Participants
Unit of Measure: Participants
0
   0.0%
0
   0.0%
19.Secondary Outcome
Title 30-day Point Prevalence Abstinence Rates
Hide Description Participants who self-reported not smoking for 30 days prior to the specified timepoint.
Time Frame 1 month follow up
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Learn to Quit NCI QuitGuide
Hide Arm/Group Description:
A smartphone app developed by the research team designed for people with serious mental illness, that provides Acceptance and Commitment Therapy skills to address (a) smoking cessation and (b) mental health symptoms. This app intervention is combined with an 8-week course of nicotine replacement therapy (NRT) patches and a 2-week course of NRT lozenges. Participants also receive technical smartphone coaching for the first 4 weeks of the study.
A smartphone app developed by the National Cancer Institute which uses smoking cessation recommendations contained in the US DHHS Clinical Practice Guidelines. The app intervention is combined with an 8-week course of nicotine replacement therapy (NRT) patches and a 2-week course of NRT lozenges. Participants also receive technical smartphone coaching for the first 4 weeks of the study.
Overall Number of Participants Analyzed 33 29
Measure Type: Count of Participants
Unit of Measure: Participants
0
   0.0%
1
   3.4%
20.Secondary Outcome
Title 30-day Point Prevalence Abstinence Rates
Hide Description Participants who self-reported not smoking for 30 days prior to the specified timepoint.
Time Frame 2 month follow up
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Learn to Quit NCI QuitGuide
Hide Arm/Group Description:
A smartphone app developed by the research team designed for people with serious mental illness, that provides Acceptance and Commitment Therapy skills to address (a) smoking cessation and (b) mental health symptoms. This app intervention is combined with an 8-week course of nicotine replacement therapy (NRT) patches and a 2-week course of NRT lozenges. Participants also receive technical smartphone coaching for the first 4 weeks of the study.
A smartphone app developed by the National Cancer Institute which uses smoking cessation recommendations contained in the US DHHS Clinical Practice Guidelines. The app intervention is combined with an 8-week course of nicotine replacement therapy (NRT) patches and a 2-week course of NRT lozenges. Participants also receive technical smartphone coaching for the first 4 weeks of the study.
Overall Number of Participants Analyzed 33 29
Measure Type: Count of Participants
Unit of Measure: Participants
3
   9.1%
2
   6.9%
21.Secondary Outcome
Title 30-day Prevalence Abstinence Rates
Hide Description Participants who self-reported not smoking for 30 days prior to the specified timepoint.
Time Frame 3 month follow up
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Learn to Quit NCI QuitGuide
Hide Arm/Group Description:
A smartphone app developed by the research team designed for people with serious mental illness, that provides Acceptance and Commitment Therapy skills to address (a) smoking cessation and (b) mental health symptoms. This app intervention is combined with an 8-week course of nicotine replacement therapy (NRT) patches and a 2-week course of NRT lozenges. Participants also receive technical smartphone coaching for the first 4 weeks of the study.
A smartphone app developed by the National Cancer Institute which uses smoking cessation recommendations contained in the US DHHS Clinical Practice Guidelines. The app intervention is combined with an 8-week course of nicotine replacement therapy (NRT) patches and a 2-week course of NRT lozenges. Participants also receive technical smartphone coaching for the first 4 weeks of the study.
Overall Number of Participants Analyzed 33 29
Measure Type: Count of Participants
Unit of Measure: Participants
1
   3.0%
3
  10.3%
22.Secondary Outcome
Title 30-day Point Prevalence Abstinence Rates
Hide Description Participants who self-reported not smoking for 30 days prior to the specified timepoint.
Time Frame 4 month follow up
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Learn to Quit NCI QuitGuide
Hide Arm/Group Description:
A smartphone app developed by the research team designed for people with serious mental illness, that provides Acceptance and Commitment Therapy skills to address (a) smoking cessation and (b) mental health symptoms. This app intervention is combined with an 8-week course of nicotine replacement therapy (NRT) patches and a 2-week course of NRT lozenges. Participants also receive technical smartphone coaching for the first 4 weeks of the study.
A smartphone app developed by the National Cancer Institute which uses smoking cessation recommendations contained in the US DHHS Clinical Practice Guidelines. The app intervention is combined with an 8-week course of nicotine replacement therapy (NRT) patches and a 2-week course of NRT lozenges. Participants also receive technical smartphone coaching for the first 4 weeks of the study.
Overall Number of Participants Analyzed 33 29
Measure Type: Count of Participants
Unit of Measure: Participants
4
  12.1%
3
  10.3%
23.Secondary Outcome
Title 7-day Point Prevalence Abstinence
Hide Description Participants who self-reported not smoking for 7 days prior to the specified timepoint.
Time Frame 1 month follow up
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Learn to Quit NCI QuitGuide
Hide Arm/Group Description:
A smartphone app developed by the research team designed for people with serious mental illness, that provides Acceptance and Commitment Therapy skills to address (a) smoking cessation and (b) mental health symptoms. This app intervention is combined with an 8-week course of nicotine replacement therapy (NRT) patches and a 2-week course of NRT lozenges. Participants also receive technical smartphone coaching for the first 4 weeks of the study.
A smartphone app developed by the National Cancer Institute which uses smoking cessation recommendations contained in the US DHHS Clinical Practice Guidelines. The app intervention is combined with an 8-week course of nicotine replacement therapy (NRT) patches and a 2-week course of NRT lozenges. Participants also receive technical smartphone coaching for the first 4 weeks of the study.
Overall Number of Participants Analyzed 33 29
Measure Type: Count of Participants
Unit of Measure: Participants
4
  12.1%
7
  24.1%
24.Secondary Outcome
Title 7-day Point Prevalence Abstinence
Hide Description Participants who self-reported not smoking for 7 days prior to the specified timepoint.
Time Frame 2 month follow up
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Learn to Quit NCI QuitGuide
Hide Arm/Group Description:
A smartphone app developed by the research team designed for people with serious mental illness, that provides Acceptance and Commitment Therapy skills to address (a) smoking cessation and (b) mental health symptoms. This app intervention is combined with an 8-week course of nicotine replacement therapy (NRT) patches and a 2-week course of NRT lozenges. Participants also receive technical smartphone coaching for the first 4 weeks of the study.
A smartphone app developed by the National Cancer Institute which uses smoking cessation recommendations contained in the US DHHS Clinical Practice Guidelines. The app intervention is combined with an 8-week course of nicotine replacement therapy (NRT) patches and a 2-week course of NRT lozenges. Participants also receive technical smartphone coaching for the first 4 weeks of the study.
Overall Number of Participants Analyzed 33 29
Measure Type: Count of Participants
Unit of Measure: Participants
6
  18.2%
2
   6.9%
25.Secondary Outcome
Title 7-day Point Prevalence Abstinence
Hide Description Participants who self-reported not smoking for 7 days prior to the specified timepoint.
Time Frame 3 month follow up
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Learn to Quit NCI QuitGuide
Hide Arm/Group Description:
A smartphone app developed by the research team designed for people with serious mental illness, that provides Acceptance and Commitment Therapy skills to address (a) smoking cessation and (b) mental health symptoms. This app intervention is combined with an 8-week course of nicotine replacement therapy (NRT) patches and a 2-week course of NRT lozenges. Participants also receive technical smartphone coaching for the first 4 weeks of the study.
A smartphone app developed by the National Cancer Institute which uses smoking cessation recommendations contained in the US DHHS Clinical Practice Guidelines. The app intervention is combined with an 8-week course of nicotine replacement therapy (NRT) patches and a 2-week course of NRT lozenges. Participants also receive technical smartphone coaching for the first 4 weeks of the study.
Overall Number of Participants Analyzed 33 29
Measure Type: Count of Participants
Unit of Measure: Participants
5
  15.2%
4
  13.8%
26.Secondary Outcome
Title 7-day Point Prevalence Abstinence
Hide Description Participants who self-reported not smoking for 7 days prior to the specified timepoint.
Time Frame 4 month follow up
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Learn to Quit NCI QuitGuide
Hide Arm/Group Description:
A smartphone app developed by the research team designed for people with serious mental illness, that provides Acceptance and Commitment Therapy skills to address (a) smoking cessation and (b) mental health symptoms. This app intervention is combined with an 8-week course of nicotine replacement therapy (NRT) patches and a 2-week course of NRT lozenges. Participants also receive technical smartphone coaching for the first 4 weeks of the study.
A smartphone app developed by the National Cancer Institute which uses smoking cessation recommendations contained in the US DHHS Clinical Practice Guidelines. The app intervention is combined with an 8-week course of nicotine replacement therapy (NRT) patches and a 2-week course of NRT lozenges. Participants also receive technical smartphone coaching for the first 4 weeks of the study.
Overall Number of Participants Analyzed 33 29
Measure Type: Count of Participants
Unit of Measure: Participants
4
  12.1%
3
  10.3%
27.Secondary Outcome
Title 24-hour Point Prevalence Abstinence
Hide Description Participants who self-reported not smoking for 24 hours prior to the specified timepoint.
Time Frame 1 month follow up
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Learn to Quit NCI QuitGuide
Hide Arm/Group Description:
A smartphone app developed by the research team designed for people with serious mental illness, that provides Acceptance and Commitment Therapy skills to address (a) smoking cessation and (b) mental health symptoms. This app intervention is combined with an 8-week course of nicotine replacement therapy (NRT) patches and a 2-week course of NRT lozenges. Participants also receive technical smartphone coaching for the first 4 weeks of the study.
A smartphone app developed by the National Cancer Institute which uses smoking cessation recommendations contained in the US DHHS Clinical Practice Guidelines. The app intervention is combined with an 8-week course of nicotine replacement therapy (NRT) patches and a 2-week course of NRT lozenges. Participants also receive technical smartphone coaching for the first 4 weeks of the study.
Overall Number of Participants Analyzed 33 29
Measure Type: Count of Participants
Unit of Measure: Participants
8
  24.2%
10
  34.5%
28.Secondary Outcome
Title 24-hour Point Prevalence Abstinence
Hide Description Participants who self-reported not smoking for 24 hours prior to the specified timepoint.
Time Frame 2 month follow up
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Learn to Quit NCI QuitGuide
Hide Arm/Group Description:
A smartphone app developed by the research team designed for people with serious mental illness, that provides Acceptance and Commitment Therapy skills to address (a) smoking cessation and (b) mental health symptoms. This app intervention is combined with an 8-week course of nicotine replacement therapy (NRT) patches and a 2-week course of NRT lozenges. Participants also receive technical smartphone coaching for the first 4 weeks of the study.
A smartphone app developed by the National Cancer Institute which uses smoking cessation recommendations contained in the US DHHS Clinical Practice Guidelines. The app intervention is combined with an 8-week course of nicotine replacement therapy (NRT) patches and a 2-week course of NRT lozenges. Participants also receive technical smartphone coaching for the first 4 weeks of the study.
Overall Number of Participants Analyzed 33 29
Measure Type: Count of Participants
Unit of Measure: Participants
8
  24.2%
7
  24.1%
29.Secondary Outcome
Title 24-hour Point Prevalence Abstinence
Hide Description Participants who self-reported not smoking for 24 hours prior to the specified timepoint.
Time Frame 3 month follow up
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Learn to Quit NCI QuitGuide
Hide Arm/Group Description:
A smartphone app developed by the research team designed for people with serious mental illness, that provides Acceptance and Commitment Therapy skills to address (a) smoking cessation and (b) mental health symptoms. This app intervention is combined with an 8-week course of nicotine replacement therapy (NRT) patches and a 2-week course of NRT lozenges. Participants also receive technical smartphone coaching for the first 4 weeks of the study.
A smartphone app developed by the National Cancer Institute which uses smoking cessation recommendations contained in the US DHHS Clinical Practice Guidelines. The app intervention is combined with an 8-week course of nicotine replacement therapy (NRT) patches and a 2-week course of NRT lozenges. Participants also receive technical smartphone coaching for the first 4 weeks of the study.
Overall Number of Participants Analyzed 33 29
Measure Type: Count of Participants
Unit of Measure: Participants
6
  18.2%
6
  20.7%
30.Secondary Outcome
Title 24-hour Point Prevalence Abstinence
Hide Description Participants who self-reported not smoking for 24 hours prior to the specified timepoint.
Time Frame 4 month follow up
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Learn to Quit NCI QuitGuide
Hide Arm/Group Description:
A smartphone app developed by the research team designed for people with serious mental illness, that provides Acceptance and Commitment Therapy skills to address (a) smoking cessation and (b) mental health symptoms. This app intervention is combined with an 8-week course of nicotine replacement therapy (NRT) patches and a 2-week course of NRT lozenges. Participants also receive technical smartphone coaching for the first 4 weeks of the study.
A smartphone app developed by the National Cancer Institute which uses smoking cessation recommendations contained in the US DHHS Clinical Practice Guidelines. The app intervention is combined with an 8-week course of nicotine replacement therapy (NRT) patches and a 2-week course of NRT lozenges. Participants also receive technical smartphone coaching for the first 4 weeks of the study.
Overall Number of Participants Analyzed 33 29
Measure Type: Count of Participants
Unit of Measure: Participants
7
  21.2%
7
  24.1%
31.Secondary Outcome
Title Average Number of Quit Attempts Per Arm
Hide Description Average number of quit attempts per group defined as self-reported no smoking at all for 24 hours at the specified time point.
Time Frame 1 month follow up
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Learn to Quit NCI QuitGuide
Hide Arm/Group Description:
A smartphone app developed by the research team designed for people with serious mental illness, that provides Acceptance and Commitment Therapy skills to address (a) smoking cessation and (b) mental health symptoms. This app intervention is combined with an 8-week course of nicotine replacement therapy (NRT) patches and a 2-week course of NRT lozenges. Participants also receive technical smartphone coaching for the first 4 weeks of the study.
A smartphone app developed by the National Cancer Institute which uses smoking cessation recommendations contained in the US DHHS Clinical Practice Guidelines. The app intervention is combined with an 8-week course of nicotine replacement therapy (NRT) patches and a 2-week course of NRT lozenges. Participants also receive technical smartphone coaching for the first 4 weeks of the study.
Overall Number of Participants Analyzed 33 29
Mean (Standard Deviation)
Unit of Measure: quit attempts
1.16  (1.19) 3.04  (2.29)
32.Secondary Outcome
Title Average Number of Quit Attempts Per Arm
Hide Description Average number of quit attempts per group defined as self-reported no smoking at all for 24 hours at the specified time point.
Time Frame 2 month follow up
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Learn to Quit NCI QuitGuide
Hide Arm/Group Description:
A smartphone app developed by the research team designed for people with serious mental illness, that provides Acceptance and Commitment Therapy skills to address (a) smoking cessation and (b) mental health symptoms. This app intervention is combined with an 8-week course of nicotine replacement therapy (NRT) patches and a 2-week course of NRT lozenges. Participants also receive technical smartphone coaching for the first 4 weeks of the study.
A smartphone app developed by the National Cancer Institute which uses smoking cessation recommendations contained in the US DHHS Clinical Practice Guidelines. The app intervention is combined with an 8-week course of nicotine replacement therapy (NRT) patches and a 2-week course of NRT lozenges. Participants also receive technical smartphone coaching for the first 4 weeks of the study.
Overall Number of Participants Analyzed 33 29
Mean (Standard Deviation)
Unit of Measure: quit attempts
1.44  (1.34) 2.55  (1.82)
33.Secondary Outcome
Title Average Number of Quit Attempts Per Arm
Hide Description Average number of quit attempts per group defined as self-reported no smoking at all for 24 hours at the specified time point.
Time Frame 3 month follow up
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Learn to Quit NCI QuitGuide
Hide Arm/Group Description:
A smartphone app developed by the research team designed for people with serious mental illness, that provides Acceptance and Commitment Therapy skills to address (a) smoking cessation and (b) mental health symptoms. This app intervention is combined with an 8-week course of nicotine replacement therapy (NRT) patches and a 2-week course of NRT lozenges. Participants also receive technical smartphone coaching for the first 4 weeks of the study.
A smartphone app developed by the National Cancer Institute which uses smoking cessation recommendations contained in the US DHHS Clinical Practice Guidelines. The app intervention is combined with an 8-week course of nicotine replacement therapy (NRT) patches and a 2-week course of NRT lozenges. Participants also receive technical smartphone coaching for the first 4 weeks of the study.
Overall Number of Participants Analyzed 33 29
Mean (Standard Deviation)
Unit of Measure: quit attempts
1.83  (2.17) 3.30  (3.61)
34.Secondary Outcome
Title Average Number of Quit Attempts Per Arm
Hide Description Average number of quit attempts per group defined as self-reported no smoking at all for 24 hours at the specified time point.
Time Frame 4 month follow up
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Learn to Quit NCI QuitGuide
Hide Arm/Group Description:
A smartphone app developed by the research team designed for people with serious mental illness, that provides Acceptance and Commitment Therapy skills to address (a) smoking cessation and (b) mental health symptoms. This app intervention is combined with an 8-week course of nicotine replacement therapy (NRT) patches and a 2-week course of NRT lozenges. Participants also receive technical smartphone coaching for the first 4 weeks of the study.
A smartphone app developed by the National Cancer Institute which uses smoking cessation recommendations contained in the US DHHS Clinical Practice Guidelines. The app intervention is combined with an 8-week course of nicotine replacement therapy (NRT) patches and a 2-week course of NRT lozenges. Participants also receive technical smartphone coaching for the first 4 weeks of the study.
Overall Number of Participants Analyzed 33 29
Mean (Standard Deviation)
Unit of Measure: quit attempts
1.61  (1.85) 1.96  (1.90)
35.Secondary Outcome
Title Change in Nicotine Dependence as Measured by the Fagerstrom Test of Nicotine Dependence
Hide Description The Fagerstrom Test of Nicotine Dependence ranges from 0 to 10 with the lower score indicating "no dependence" and the highest score indicating "very dependent"
Time Frame Baseline to 1, 2, 3 and 4 month follow up
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Learn to Quit NCI QuitGuide
Hide Arm/Group Description:
A smartphone app developed by the research team designed for people with serious mental illness, that provides Acceptance and Commitment Therapy skills to address (a) smoking cessation and (b) mental health symptoms. This app intervention is combined with an 8-week course of nicotine replacement therapy (NRT) patches and a 2-week course of NRT lozenges. Participants also receive technical smartphone coaching for the first 4 weeks of the study.
A smartphone app developed by the National Cancer Institute which uses smoking cessation recommendations contained in the US DHHS Clinical Practice Guidelines. The app intervention is combined with an 8-week course of nicotine replacement therapy (NRT) patches and a 2-week course of NRT lozenges. Participants also receive technical smartphone coaching for the first 4 weeks of the study.
Overall Number of Participants Analyzed 33 29
Mean (Standard Deviation)
Unit of Measure: units on a scale
Week 4 0.81  (2.17) 1.88  (2.90)
Week 8 1  (1.97) 1.47  (2.67)
Week 12 1.29  (2.03) 1.74  (2.40)
Week 16 1.16  (2.03) 1.35  (2.48)
36.Secondary Outcome
Title Change in Average Number of Cigarettes Smoked Per Day
Hide Description Change in average number of self-reported cigarettes smoked per day per arm from baseline to the specified time point.
Time Frame Baseline to 1, 2, 3 and 4 month follow up
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Learn to Quit NCI QuitGuide
Hide Arm/Group Description:
A smartphone app developed by the research team designed for people with serious mental illness, that provides Acceptance and Commitment Therapy skills to address (a) smoking cessation and (b) mental health symptoms. This app intervention is combined with an 8-week course of nicotine replacement therapy (NRT) patches and a 2-week course of NRT lozenges. Participants also receive technical smartphone coaching for the first 4 weeks of the study.
A smartphone app developed by the National Cancer Institute which uses smoking cessation recommendations contained in the US DHHS Clinical Practice Guidelines. The app intervention is combined with an 8-week course of nicotine replacement therapy (NRT) patches and a 2-week course of NRT lozenges. Participants also receive technical smartphone coaching for the first 4 weeks of the study.
Overall Number of Participants Analyzed 33 29
Mean (Standard Deviation)
Unit of Measure: cigarettes per day
Week 4 10.0  (9.9) 5.2  (10.8)
Week 8 11.3  (12.0) 7.5  (7.6)
Week 12 11.5  (12.3) 6.0  (7.6)
Week 16 12.3  (11.5) 5.9  (5.9)
37.Secondary Outcome
Title Nicotine Replacement Patch Utilization
Hide Description Days of patch use over the last 30 days.
Time Frame 1 month follow up
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Learn to Quit NCI QuitGuide
Hide Arm/Group Description:
A smartphone app developed by the research team designed for people with serious mental illness, that provides Acceptance and Commitment Therapy skills to address (a) smoking cessation and (b) mental health symptoms. This app intervention is combined with an 8-week course of nicotine replacement therapy (NRT) patches and a 2-week course of NRT lozenges. Participants also receive technical smartphone coaching for the first 4 weeks of the study.
A smartphone app developed by the National Cancer Institute which uses smoking cessation recommendations contained in the US DHHS Clinical Practice Guidelines. The app intervention is combined with an 8-week course of nicotine replacement therapy (NRT) patches and a 2-week course of NRT lozenges. Participants also receive technical smartphone coaching for the first 4 weeks of the study.
Overall Number of Participants Analyzed 33 29
Mean (Standard Deviation)
Unit of Measure: days of patch use
10.3  (10.4) 13.9  (11.6)
38.Secondary Outcome
Title Nicotine Replacement Patch Utilization
Hide Description Days of patch use over the last 30 days.
Time Frame 2 month follow up
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Learn to Quit NCI QuitGuide
Hide Arm/Group Description:
A smartphone app developed by the research team designed for people with serious mental illness, that provides Acceptance and Commitment Therapy skills to address (a) smoking cessation and (b) mental health symptoms. This app intervention is combined with an 8-week course of nicotine replacement therapy (NRT) patches and a 2-week course of NRT lozenges. Participants also receive technical smartphone coaching for the first 4 weeks of the study.
A smartphone app developed by the National Cancer Institute which uses smoking cessation recommendations contained in the US DHHS Clinical Practice Guidelines. The app intervention is combined with an 8-week course of nicotine replacement therapy (NRT) patches and a 2-week course of NRT lozenges. Participants also receive technical smartphone coaching for the first 4 weeks of the study.
Overall Number of Participants Analyzed 33 29
Mean (Standard Deviation)
Unit of Measure: days of patch use
11  (11.2) 14.9  (12.8)
39.Secondary Outcome
Title Nicotine Replacement Patch Utilization
Hide Description Days of patch use over the last 30 days.
Time Frame 3 month follow up
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Learn to Quit NCI QuitGuide
Hide Arm/Group Description:
A smartphone app developed by the research team designed for people with serious mental illness, that provides Acceptance and Commitment Therapy skills to address (a) smoking cessation and (b) mental health symptoms. This app intervention is combined with an 8-week course of nicotine replacement therapy (NRT) patches and a 2-week course of NRT lozenges. Participants also receive technical smartphone coaching for the first 4 weeks of the study.
A smartphone app developed by the National Cancer Institute which uses smoking cessation recommendations contained in the US DHHS Clinical Practice Guidelines. The app intervention is combined with an 8-week course of nicotine replacement therapy (NRT) patches and a 2-week course of NRT lozenges. Participants also receive technical smartphone coaching for the first 4 weeks of the study.
Overall Number of Participants Analyzed 33 29
Mean (Standard Deviation)
Unit of Measure: days of patch use
8.4  (10.7) 7.4  (9.5)
40.Secondary Outcome
Title Nicotine Replacement Patch Utilization
Hide Description Days of patch use over the last 30 days.
Time Frame 4 month follow up
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Learn to Quit NCI QuitGuide
Hide Arm/Group Description:
A smartphone app developed by the research team designed for people with serious mental illness, that provides Acceptance and Commitment Therapy skills to address (a) smoking cessation and (b) mental health symptoms. This app intervention is combined with an 8-week course of nicotine replacement therapy (NRT) patches and a 2-week course of NRT lozenges. Participants also receive technical smartphone coaching for the first 4 weeks of the study.
A smartphone app developed by the National Cancer Institute which uses smoking cessation recommendations contained in the US DHHS Clinical Practice Guidelines. The app intervention is combined with an 8-week course of nicotine replacement therapy (NRT) patches and a 2-week course of NRT lozenges. Participants also receive technical smartphone coaching for the first 4 weeks of the study.
Overall Number of Participants Analyzed 33 29
Mean (Standard Deviation)
Unit of Measure: days of patch use
3.4  (6.2) 5.3  (8.6)
41.Secondary Outcome
Title Nicotine Replacement Lozenge Utilization
Hide Description Days of lozenge use over the last 30 days.
Time Frame 1 month follow up
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Learn to Quit NCI QuitGuide
Hide Arm/Group Description:
A smartphone app developed by the research team designed for people with serious mental illness, that provides Acceptance and Commitment Therapy skills to address (a) smoking cessation and (b) mental health symptoms. This app intervention is combined with an 8-week course of nicotine replacement therapy (NRT) patches and a 2-week course of NRT lozenges. Participants also receive technical smartphone coaching for the first 4 weeks of the study.
A smartphone app developed by the National Cancer Institute which uses smoking cessation recommendations contained in the US DHHS Clinical Practice Guidelines. The app intervention is combined with an 8-week course of nicotine replacement therapy (NRT) patches and a 2-week course of NRT lozenges. Participants also receive technical smartphone coaching for the first 4 weeks of the study.
Overall Number of Participants Analyzed 33 29
Mean (Standard Deviation)
Unit of Measure: days of lozenge use
7.8  (9.7) 10  (10)
42.Secondary Outcome
Title Nicotine Replacement Lozenge Utilization
Hide Description Days of lozenge use over the last 30 days.
Time Frame 2 month follow up
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Learn to Quit NCI QuitGuide
Hide Arm/Group Description:
A smartphone app developed by the research team designed for people with serious mental illness, that provides Acceptance and Commitment Therapy skills to address (a) smoking cessation and (b) mental health symptoms. This app intervention is combined with an 8-week course of nicotine replacement therapy (NRT) patches and a 2-week course of NRT lozenges. Participants also receive technical smartphone coaching for the first 4 weeks of the study.
A smartphone app developed by the National Cancer Institute which uses smoking cessation recommendations contained in the US DHHS Clinical Practice Guidelines. The app intervention is combined with an 8-week course of nicotine replacement therapy (NRT) patches and a 2-week course of NRT lozenges. Participants also receive technical smartphone coaching for the first 4 weeks of the study.
Overall Number of Participants Analyzed 33 29
Mean (Standard Deviation)
Unit of Measure: days of lozenge use
5.1  (9.3) 7  (10.4)
43.Secondary Outcome
Title Nicotine Replacement Lozenge Utilization
Hide Description Days of lozenge use over the last 30 days.
Time Frame 3 month follow up
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Learn to Quit NCI QuitGuide
Hide Arm/Group Description:
A smartphone app developed by the research team designed for people with serious mental illness, that provides Acceptance and Commitment Therapy skills to address (a) smoking cessation and (b) mental health symptoms. This app intervention is combined with an 8-week course of nicotine replacement therapy (NRT) patches and a 2-week course of NRT lozenges. Participants also receive technical smartphone coaching for the first 4 weeks of the study.
A smartphone app developed by the National Cancer Institute which uses smoking cessation recommendations contained in the US DHHS Clinical Practice Guidelines. The app intervention is combined with an 8-week course of nicotine replacement therapy (NRT) patches and a 2-week course of NRT lozenges. Participants also receive technical smartphone coaching for the first 4 weeks of the study.
Overall Number of Participants Analyzed 33 29
Mean (Standard Deviation)
Unit of Measure: days of lozenge use
4.4  (8) 4.1  (7.2)
44.Secondary Outcome
Title Nicotine Replacement Lozenge Utilization
Hide Description Days of lozenge use over the last 30 days.
Time Frame 4 month follow up
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Learn to Quit NCI QuitGuide
Hide Arm/Group Description:
A smartphone app developed by the research team designed for people with serious mental illness, that provides Acceptance and Commitment Therapy skills to address (a) smoking cessation and (b) mental health symptoms. This app intervention is combined with an 8-week course of nicotine replacement therapy (NRT) patches and a 2-week course of NRT lozenges. Participants also receive technical smartphone coaching for the first 4 weeks of the study.
A smartphone app developed by the National Cancer Institute which uses smoking cessation recommendations contained in the US DHHS Clinical Practice Guidelines. The app intervention is combined with an 8-week course of nicotine replacement therapy (NRT) patches and a 2-week course of NRT lozenges. Participants also receive technical smartphone coaching for the first 4 weeks of the study.
Overall Number of Participants Analyzed 33 29
Mean (Standard Deviation)
Unit of Measure: days of lozenge use
2.3  (6.3) 1.3  (3.1)
45.Secondary Outcome
Title Affect Ratings - Learn to Quit
Hide Description Average mood rating as self-reported through the Learn to Quit app. Ratings range from 1-10 with lower scores indicating poorer mood ratings.
Time Frame Daily throughout study duration, 4 months
Hide Outcome Measure Data
Hide Analysis Population Description
Participants in the Learn to Quit group.
Arm/Group Title Learn to Quit
Hide Arm/Group Description:
A smartphone app developed by the research team designed for people with serious mental illness, that provides Acceptance and Commitment Therapy skills to address (a) smoking cessation and (b) mental health symptoms. This app intervention is combined with an 8-week course of nicotine replacement therapy (NRT) patches and a 2-week course of NRT lozenges. Participants also receive technical smartphone coaching for the first 4 weeks of the study.
Overall Number of Participants Analyzed 33
Mean (Standard Deviation)
Unit of Measure: score on a scale
5.4666165  (2.155668)
46.Secondary Outcome
Title Affect Ratings - QuitGuide
Hide Description Percent of reported positive, negative, and mixed affect. Negative affect was coded as '1' when the following types of mood were reported using the mood tracking feature within the app: frustrated, stressed, nervous, anxious, angry, sad. Positive affect was coded as '1' when the following types of mood were reported using the mood tracking feature within the app: happy, relaxed, excited. Mixed affect was coded as '1' when there were instances where participants reported both positive and negative affect at different times of the day.
Time Frame Daily throughout study, 4 months
Hide Outcome Measure Data
Hide Analysis Population Description
Participants in the QuitGuide group.
Arm/Group Title QuitGuide
Hide Arm/Group Description:
A smartphone app developed by the National Cancer Institute which uses smoking cessation recommendations contained in the US DHHS Clinical Practice Guidelines. The app intervention is combined with an 8-week course of nicotine replacement therapy (NRT) patches and a 2-week course of NRT lozenges. Participants also receive technical smartphone coaching for the first 4 weeks of the study.
Overall Number of Participants Analyzed 29
Measure Type: Number
Unit of Measure: Percent of counts
Positive Affect 52.26
Negative Affect 43.90
Mixed Affect 3.83
47.Secondary Outcome
Title Smoking Cravings
Hide Description Average daily smoking cravings as self-reported through each smartphone app. Cravings range from a score of 1 to 10 with higher scores indicating higher cravings to smoke.
Time Frame Daily throughout study duration, 4 months
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Learn to Quit NCI QuitGuide
Hide Arm/Group Description:
A smartphone app developed by the research team designed for people with serious mental illness, that provides Acceptance and Commitment Therapy skills to address (a) smoking cessation and (b) mental health symptoms. This app intervention is combined with an 8-week course of nicotine replacement therapy (NRT) patches and a 2-week course of NRT lozenges. Participants also receive technical smartphone coaching for the first 4 weeks of the study.
A smartphone app developed by the National Cancer Institute which uses smoking cessation recommendations contained in the US DHHS Clinical Practice Guidelines. The app intervention is combined with an 8-week course of nicotine replacement therapy (NRT) patches and a 2-week course of NRT lozenges. Participants also receive technical smartphone coaching for the first 4 weeks of the study.
Overall Number of Participants Analyzed 33 29
Mean (Standard Deviation)
Unit of Measure: units on a scale
6.13  (2.25) 4.55  (2.98)
48.Secondary Outcome
Title Psychotic Symptoms
Hide Description Psychotic symptoms (positive and negative symptoms) at the specified time point as measured by the Positive and Negative Symptoms Scale. Scores range from 7 to 49 with higher scores indicating more psychopathology.
Time Frame 1 month follow up
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Learn to Quit NCI QuitGuide
Hide Arm/Group Description:
A smartphone app developed by the research team designed for people with serious mental illness, that provides Acceptance and Commitment Therapy skills to address (a) smoking cessation and (b) mental health symptoms. This app intervention is combined with an 8-week course of nicotine replacement therapy (NRT) patches and a 2-week course of NRT lozenges. Participants also receive technical smartphone coaching for the first 4 weeks of the study.
A smartphone app developed by the National Cancer Institute which uses smoking cessation recommendations contained in the US DHHS Clinical Practice Guidelines. The app intervention is combined with an 8-week course of nicotine replacement therapy (NRT) patches and a 2-week course of NRT lozenges. Participants also receive technical smartphone coaching for the first 4 weeks of the study.
Overall Number of Participants Analyzed 33 29
Mean (Standard Deviation)
Unit of Measure: score on a scale
Positive symptoms 11.74  (3.43) 11.85  (3.52)
Negative symptoms 11.61  (4.38) 10.81  (4.33)
49.Secondary Outcome
Title Psychotic Symptoms
Hide Description Psychotic symptoms (positive and negative symptoms) at the specified time point as measured by the Positive and Negative Symptoms Scale. Scores range from 7 to 49 with higher scores indicating more psychopathology.
Time Frame 2 month follow up
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Learn to Quit NCI QuitGuide
Hide Arm/Group Description:
A smartphone app developed by the research team designed for people with serious mental illness, that provides Acceptance and Commitment Therapy skills to address (a) smoking cessation and (b) mental health symptoms. This app intervention is combined with an 8-week course of nicotine replacement therapy (NRT) patches and a 2-week course of NRT lozenges. Participants also receive technical smartphone coaching for the first 4 weeks of the study.
A smartphone app developed by the National Cancer Institute which uses smoking cessation recommendations contained in the US DHHS Clinical Practice Guidelines. The app intervention is combined with an 8-week course of nicotine replacement therapy (NRT) patches and a 2-week course of NRT lozenges. Participants also receive technical smartphone coaching for the first 4 weeks of the study.
Overall Number of Participants Analyzed 33 29
Mean (Standard Deviation)
Unit of Measure: score on a scale
Positive symptoms 11.55  (3.49) 10.79  (3.79)
Negative symptoms 12.45  (4.42) 11.38  (5.38)
50.Secondary Outcome
Title Psychotic Symptoms
Hide Description Psychotic symptoms (positive and negative symptoms) at the specified time point as measured by the Positive and Negative Symptoms Scale. Scores range from 7 to 49 with higher scores indicating more psychopathology.
Time Frame 3 month follow up
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Learn to Quit NCI QuitGuide
Hide Arm/Group Description:
A smartphone app developed by the research team designed for people with serious mental illness, that provides Acceptance and Commitment Therapy skills to address (a) smoking cessation and (b) mental health symptoms. This app intervention is combined with an 8-week course of nicotine replacement therapy (NRT) patches and a 2-week course of NRT lozenges. Participants also receive technical smartphone coaching for the first 4 weeks of the study.
A smartphone app developed by the National Cancer Institute which uses smoking cessation recommendations contained in the US DHHS Clinical Practice Guidelines. The app intervention is combined with an 8-week course of nicotine replacement therapy (NRT) patches and a 2-week course of NRT lozenges. Participants also receive technical smartphone coaching for the first 4 weeks of the study.
Overall Number of Participants Analyzed 33 29
Mean (Standard Deviation)
Unit of Measure: score on a scale
Positive symptoms 11.10  (4.21) 12.32  (5.00)
Negative symptoms 12.57  (5.82) 12.25  (5.08)
51.Secondary Outcome
Title Psychotic Symptoms
Hide Description Psychotic symptoms (positive and negative symptoms) at the specified time point as measured by the Positive and Negative Symptoms Scale. Scores range from 7 to 49 with higher scores indicating more psychopathology.
Time Frame 4 month follow up
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Learn to Quit NCI QuitGuide
Hide Arm/Group Description:
A smartphone app developed by the research team designed for people with serious mental illness, that provides Acceptance and Commitment Therapy skills to address (a) smoking cessation and (b) mental health symptoms. This app intervention is combined with an 8-week course of nicotine replacement therapy (NRT) patches and a 2-week course of NRT lozenges. Participants also receive technical smartphone coaching for the first 4 weeks of the study.
A smartphone app developed by the National Cancer Institute which uses smoking cessation recommendations contained in the US DHHS Clinical Practice Guidelines. The app intervention is combined with an 8-week course of nicotine replacement therapy (NRT) patches and a 2-week course of NRT lozenges. Participants also receive technical smartphone coaching for the first 4 weeks of the study.
Overall Number of Participants Analyzed 33 29
Mean (Standard Deviation)
Unit of Measure: score on a scale
Positive symptoms 11.63  (4.53) 11.55  (3.86)
Negative symptoms 12.16  (4.25) 12.23  (5.23)
52.Secondary Outcome
Title General Psychiatric Symptoms
Hide Description General psychiatric symptoms at the specified time point as measured by the Global Severity Index of the Brief Symptom Inventory. Scores range from 0 to 4 with higher scores indicating more psychiatric symptoms.
Time Frame 1 month follow up
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Learn to Quit NCI QuitGuide
Hide Arm/Group Description:
A smartphone app developed by the research team designed for people with serious mental illness, that provides Acceptance and Commitment Therapy skills to address (a) smoking cessation and (b) mental health symptoms. This app intervention is combined with an 8-week course of nicotine replacement therapy (NRT) patches and a 2-week course of NRT lozenges. Participants also receive technical smartphone coaching for the first 4 weeks of the study.
A smartphone app developed by the National Cancer Institute which uses smoking cessation recommendations contained in the US DHHS Clinical Practice Guidelines. The app intervention is combined with an 8-week course of nicotine replacement therapy (NRT) patches and a 2-week course of NRT lozenges. Participants also receive technical smartphone coaching for the first 4 weeks of the study.
Overall Number of Participants Analyzed 33 29
Mean (Standard Deviation)
Unit of Measure: score on a scale
0.92  (0.59) 0.84  (0.65)
53.Secondary Outcome
Title General Psychiatric Symptoms
Hide Description General psychiatric symptoms at the specified time point as measured by the Global Severity Index of the Brief Symptom Inventory. Scores range from 0 to 4 with higher scores indicating more psychiatric symptoms.
Time Frame 2 month follow up
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Learn to Quit NCI QuitGuide
Hide Arm/Group Description:
A smartphone app developed by the research team designed for people with serious mental illness, that provides Acceptance and Commitment Therapy skills to address (a) smoking cessation and (b) mental health symptoms. This app intervention is combined with an 8-week course of nicotine replacement therapy (NRT) patches and a 2-week course of NRT lozenges. Participants also receive technical smartphone coaching for the first 4 weeks of the study.
A smartphone app developed by the National Cancer Institute which uses smoking cessation recommendations contained in the US DHHS Clinical Practice Guidelines. The app intervention is combined with an 8-week course of nicotine replacement therapy (NRT) patches and a 2-week course of NRT lozenges. Participants also receive technical smartphone coaching for the first 4 weeks of the study.
Overall Number of Participants Analyzed 33 29
Mean (Standard Deviation)
Unit of Measure: score on a scale
0.87  (0.64) 0.68  (0.58)
54.Secondary Outcome
Title General Psychiatric Symptoms
Hide Description General psychiatric symptoms at the specified time point as measured by the Global Severity Index of the Brief Symptom Inventory. Scores range from 0 to 4 with higher scores indicating more psychiatric symptoms.
Time Frame 3 month follow up
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Learn to Quit NCI QuitGuide
Hide Arm/Group Description:
A smartphone app developed by the research team designed for people with serious mental illness, that provides Acceptance and Commitment Therapy skills to address (a) smoking cessation and (b) mental health symptoms. This app intervention is combined with an 8-week course of nicotine replacement therapy (NRT) patches and a 2-week course of NRT lozenges. Participants also receive technical smartphone coaching for the first 4 weeks of the study.
A smartphone app developed by the National Cancer Institute which uses smoking cessation recommendations contained in the US DHHS Clinical Practice Guidelines. The app intervention is combined with an 8-week course of nicotine replacement therapy (NRT) patches and a 2-week course of NRT lozenges. Participants also receive technical smartphone coaching for the first 4 weeks of the study.
Overall Number of Participants Analyzed 33 29
Mean (Standard Deviation)
Unit of Measure: score on a scale
0.80  (0.58) 0.80  (0.60)
55.Secondary Outcome
Title General Psychiatric Symptoms
Hide Description General psychiatric symptoms at the specified time point as measured by the Global Severity Index of the Brief Symptom Inventory. Scores range from 0 to 4 with higher scores indicating more psychiatric symptoms.
Time Frame 4 month follow up
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Learn to Quit NCI QuitGuide
Hide Arm/Group Description:
A smartphone app developed by the research team designed for people with serious mental illness, that provides Acceptance and Commitment Therapy skills to address (a) smoking cessation and (b) mental health symptoms. This app intervention is combined with an 8-week course of nicotine replacement therapy (NRT) patches and a 2-week course of NRT lozenges. Participants also receive technical smartphone coaching for the first 4 weeks of the study.
A smartphone app developed by the National Cancer Institute which uses smoking cessation recommendations contained in the US DHHS Clinical Practice Guidelines. The app intervention is combined with an 8-week course of nicotine replacement therapy (NRT) patches and a 2-week course of NRT lozenges. Participants also receive technical smartphone coaching for the first 4 weeks of the study.
Overall Number of Participants Analyzed 33 29
Mean (Standard Deviation)
Unit of Measure: score on a scale
0.94  (0.75) 0.90  (0.64)
Time Frame 16 weeks
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Learn to Quit NCI QuitGuide
Hide Arm/Group Description A smartphone app developed by the research team designed for people with serious mental illness, that provides Acceptance and Commitment Therapy skills to address (a) smoking cessation and (b) mental health symptoms. This app intervention is combined with an 8-week course of nicotine replacement therapy (NRT) patches and a 2-week course of NRT lozenges. Participants also receive technical smartphone coaching for the first 4 weeks of the study. A smartphone app developed by the National Cancer Institute which uses smoking cessation recommendations contained in the US DHHS Clinical Practice Guidelines. The app intervention is combined with an 8-week course of nicotine replacement therapy (NRT) patches and a 2-week course of NRT lozenges. Participants also receive technical smartphone coaching for the first 4 weeks of the study.
All-Cause Mortality
Learn to Quit NCI QuitGuide
Affected / at Risk (%) Affected / at Risk (%)
Total   0/33 (0.00%)      0/29 (0.00%)    
Hide Serious Adverse Events
Learn to Quit NCI QuitGuide
Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   6/33 (18.18%)      4/29 (13.79%)    
Blood and lymphatic system disorders     
Low blood pressure   0/33 (0.00%)  0 1/29 (3.45%)  1
Hospitalization from elevated blood sugar   1/33 (3.03%)  1 0/29 (0.00%)  0
Nervous system disorders     
Mini-stroke (TIA)   1/33 (3.03%)  1 0/29 (0.00%)  0
Psychiatric disorders     
Hospitalization due to suicidal ideation   1/33 (3.03%)  2 0/29 (0.00%)  0
Respiratory, thoracic and mediastinal disorders     
Asthma attack   0/33 (0.00%)  0 1/29 (3.45%)  1
Skin and subcutaneous tissue disorders     
Second degree burns   0/33 (0.00%)  0 1/29 (3.45%)  1
Social circumstances     
Heroin overdose   0/33 (0.00%)  0 1/29 (3.45%)  1
Withdrawal from methadone   1/33 (3.03%)  1 0/29 (0.00%)  0
Surgical and medical procedures     
Knee surgery   1/33 (3.03%)  1 0/29 (0.00%)  0
Hospitalized because of two broken arms   1/33 (3.03%)  1 0/29 (0.00%)  0
Hernia repair surgery   1/33 (3.03%)  1 0/29 (0.00%)  0
Indicates events were collected by systematic assessment
Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 0%
Learn to Quit NCI QuitGuide
Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   30/33 (90.91%)      23/29 (79.31%)    
Cardiac disorders     
Increased heart rate   0/33 (0.00%)  0 1/29 (3.45%)  2
Congenital, familial and genetic disorders     
Changes in blood sugar levels   0/33 (0.00%)  0 1/29 (3.45%)  1
Eye disorders     
Vision problems   2/33 (6.06%)  2 0/29 (0.00%)  0
Gastrointestinal disorders     
Burning in mouth/throat/chest   3/33 (9.09%)  3 6/29 (20.69%)  6
Acid reflux   0/33 (0.00%)  0 3/29 (10.34%)  3
Nausea   6/33 (18.18%)  7 4/29 (13.79%)  4
Constipation   1/33 (3.03%)  1 0/29 (0.00%)  0
General disorders     
Headaches   1/33 (3.03%)  1 2/29 (6.90%)  2
Cancer   2/33 (6.06%)  2 0/29 (0.00%)  0
Infections and infestations     
Cold/flu   6/33 (18.18%)  7 5/29 (17.24%)  8
Infections   0/33 (0.00%)  0 2/29 (6.90%)  2
Sore throat   0/33 (0.00%)  0 1/29 (3.45%)  1
Metabolism and nutrition disorders     
Thyroid problems   1/33 (3.03%)  1 0/29 (0.00%)  0
Musculoskeletal and connective tissue disorders     
Body aches and pains   6/33 (18.18%)  7 6/29 (20.69%)  6
Broken/sprained body parts   6/33 (18.18%)  6 2/29 (6.90%)  2
Tooth pain   2/33 (6.06%)  2 0/29 (0.00%)  0
Neoplasms benign, malignant and unspecified (incl cysts and polyps)     
Cyst/abcess removal   1/33 (3.03%)  1 2/29 (6.90%)  2
Product Issues     
Aversion to NRT taste   1/33 (3.03%)  1 0/29 (0.00%)  0
Dry mouth while using lozenges   2/33 (6.06%)  2 0/29 (0.00%)  0
Psychiatric disorders     
Anxiety and stress  [1]  4/33 (12.12%)  4 4/29 (13.79%)  4
Suicidal ideation   3/33 (9.09%)  3 1/29 (3.45%)  1
Nightmares/vivid dreams   1/33 (3.03%)  1 5/29 (17.24%)  5
Sleep issues   2/33 (6.06%)  2 2/29 (6.90%)  2
Frustration due to phone/app issues   1/33 (3.03%)  1 1/29 (3.45%)  1
Agoraphobia   0/33 (0.00%)  0 1/29 (3.45%)  1
Opioid withdrawal   1/33 (3.03%)  1 0/29 (0.00%)  0
Memory problems   0/33 (0.00%)  0 1/29 (3.45%)  1
Changes in mood   1/33 (3.03%)  1 2/29 (6.90%)  2
Reproductive system and breast disorders     
Reproductive problems   0/33 (0.00%)  0 1/29 (3.45%)  1
Respiratory, thoracic and mediastinal disorders     
Coughing   4/33 (12.12%)  5 4/29 (13.79%)  5
Allergies/asthma   1/33 (3.03%)  1 1/29 (3.45%)  1
Hiccups   1/33 (3.03%)  1 2/29 (6.90%)  2
Congestion   3/33 (9.09%)  3 1/29 (3.45%)  1
Skin and subcutaneous tissue disorders     
Itchy/irritated skin   6/33 (18.18%)  7 6/29 (20.69%)  6
Skin breakouts   2/33 (6.06%)  2 1/29 (3.45%)  1
Lacerations   1/33 (3.03%)  1 1/29 (3.45%)  1
Social circumstances     
Accidents   1/33 (3.03%)  1 0/29 (0.00%)  0
Surgical and medical procedures     
Dental procedures   3/33 (9.09%)  3 1/29 (3.45%)  1
Tumor removal (procedure)   0/33 (0.00%)  0 1/29 (3.45%)  1
Eye procedure   1/33 (3.03%)  1 1/29 (3.45%)  1
Vascular disorders     
Changes in blood pressure   3/33 (9.09%)  4 1/29 (3.45%)  1
Indicates events were collected by systematic assessment
[1]
Feeling anxious, stressed, or "on edge"
NRT adherence measure relied on self-report. Participant stratification did not successfully balance presence of mood vs. psychotic disorders in each group. 26% of outcomes measures collected via phone or web survey due to transportation barriers.
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
Results Point of Contact
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Name/Title: Dr. Roger Vilardaga
Organization: Duke University Psychiatry & Behavioral Sciences
Phone: 9196813441
EMail: roger.vilardaga@duke.edu
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Responsible Party: Duke University
ClinicalTrials.gov Identifier: NCT03069482    
Other Study ID Numbers: Pro00075165
4R00DA037276-03 ( U.S. NIH Grant/Contract )
First Submitted: February 22, 2017
First Posted: March 3, 2017
Results First Submitted: January 17, 2020
Results First Posted: March 23, 2020
Last Update Posted: November 10, 2020