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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
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

Tracking Information
First Submitted Date  ICMJE February 22, 2017
First Posted Date  ICMJE March 3, 2017
Results First Submitted Date  ICMJE January 17, 2020
Results First Posted Date  ICMJE March 23, 2020
Last Update Posted Date November 10, 2020
Actual Study Start Date  ICMJE May 15, 2017
Actual Primary Completion Date January 17, 2019   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: March 3, 2020)
  • Days of App Use [ Time Frame: Daily throughout study duration, 4 months ]
    Frequency of app openings in each group
  • Duration of App Use [ Time Frame: Daily throughout study duration, 4 months ]
    Mean duration of app use in each group over the course of study participation (4 months)
  • Feasibility as Measured by Study Accrual Relative to Recruitment Goal [ Time Frame: Approximately 15 months ]
    Percent of subjects consented into study relative to study recruitment goal (N=90).92 subjects signed consent prior to eligibility determination and randomization.
  • Feasibility as Measured by Study Attrition [ Time Frame: 4-months ]
    Number and percentage of subjects who complete 4-month follow up assessment
  • Recruitment Yield Effort [ Time Frame: Approximately 15 months ]
    Percent of subjects responding to ads and clinician referrals
  • Feasibility of Measurement Strategy [ Time Frame: Approximately 19 months ]
    Percent completion of assessment measures. Assessment measures include surveys, questionnaires, and cognitive tasks.
  • Usability of App Design as Measured by the System Usability Scale (SUS) [ Time Frame: 1-month follow-up ]
    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.
  • Usability of App Design as Measured by the System Usability Scale (SUS) [ Time Frame: 2-month follow-up ]
    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.
  • Usability of App Design as Measured by the System Usability Scale (SUS) [ Time Frame: 3-month follow-up ]
    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.
  • Usability of App Design as Measured by the System Usability Scale (SUS) [ Time Frame: 4-month follow-up ]
    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.
Original Primary Outcome Measures  ICMJE
 (submitted: March 2, 2017)
  • Frequency of app use [ Time Frame: Daily throughout study duration, 4 months ]
    Frequency of app openings in each group
  • Time of app use [ Time Frame: Daily throughout study duration, 4 months ]
    Time of app use in each group
  • Feasibility as Measured by Study Accrual Relative to Recruitment Goal [ Time Frame: Approximately 15 months ]
    Percent of subjects enrolled relative to recruitment goal (N=90)
  • Feasibility as Measured by Study Attrition [ Time Frame: Approximately 19 months ]
    Percent of subjects who complete 4-month follow up assessment
  • Recruitment Yield Effort [ Time Frame: Approximately 15 months ]
    Percent of subjects responding to ads and clinician referrals
  • Feasibility of Measurement Strategy [ Time Frame: Approximately 19 months ]
    Percent completion of assessment measures
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: March 3, 2020)
  • Biochemically Confirmed 7-day Point Prevalence Abstinence [ Time Frame: 1 month follow-up ]
    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.
  • Biochemically Confirmed 7-day Point Prevalence Abstinence [ Time Frame: 2 month follow-up ]
    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.
  • Biochemically Confirmed 7-day Point Prevalence Abstinence [ Time Frame: 3 month follow-up ]
    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.
  • Biochemically Confirmed 7-day Point Prevalence Abstinence [ Time Frame: 4 month follow-up ]
    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.
  • Biochemically Confirmed Prolonged Abstinence Rates [ Time Frame: 1 month follow up ]
    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
  • Biochemically Confirmed Prolonged Abstinence Rates [ Time Frame: 2 month follow up ]
    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
  • Biochemically Confirmed Prolonged Abstinence Rates [ Time Frame: 3 month follow up ]
    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.
  • Biochemically Confirmed Prolonged Abstinence Rates [ Time Frame: 4 month follow up ]
    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.
  • 30-day Point Prevalence Abstinence Rates [ Time Frame: 1 month follow up ]
    Participants who self-reported not smoking for 30 days prior to the specified timepoint.
  • 30-day Point Prevalence Abstinence Rates [ Time Frame: 2 month follow up ]
    Participants who self-reported not smoking for 30 days prior to the specified timepoint.
  • 30-day Prevalence Abstinence Rates [ Time Frame: 3 month follow up ]
    Participants who self-reported not smoking for 30 days prior to the specified timepoint.
  • 30-day Point Prevalence Abstinence Rates [ Time Frame: 4 month follow up ]
    Participants who self-reported not smoking for 30 days prior to the specified timepoint.
  • 7-day Point Prevalence Abstinence [ Time Frame: 1 month follow up ]
    Participants who self-reported not smoking for 7 days prior to the specified timepoint.
  • 7-day Point Prevalence Abstinence [ Time Frame: 2 month follow up ]
    Participants who self-reported not smoking for 7 days prior to the specified timepoint.
  • 7-day Point Prevalence Abstinence [ Time Frame: 3 month follow up ]
    Participants who self-reported not smoking for 7 days prior to the specified timepoint.
  • 7-day Point Prevalence Abstinence [ Time Frame: 4 month follow up ]
    Participants who self-reported not smoking for 7 days prior to the specified timepoint.
  • 24-hour Point Prevalence Abstinence [ Time Frame: 1 month follow up ]
    Participants who self-reported not smoking for 24 hours prior to the specified timepoint.
  • 24-hour Point Prevalence Abstinence [ Time Frame: 2 month follow up ]
    Participants who self-reported not smoking for 24 hours prior to the specified timepoint.
  • 24-hour Point Prevalence Abstinence [ Time Frame: 3 month follow up ]
    Participants who self-reported not smoking for 24 hours prior to the specified timepoint.
  • 24-hour Point Prevalence Abstinence [ Time Frame: 4 month follow up ]
    Participants who self-reported not smoking for 24 hours prior to the specified timepoint.
  • Average Number of Quit Attempts Per Arm [ Time Frame: 1 month follow up ]
    Average number of quit attempts per group defined as self-reported no smoking at all for 24 hours at the specified time point.
  • Average Number of Quit Attempts Per Arm [ Time Frame: 2 month follow up ]
    Average number of quit attempts per group defined as self-reported no smoking at all for 24 hours at the specified time point.
  • Average Number of Quit Attempts Per Arm [ Time Frame: 3 month follow up ]
    Average number of quit attempts per group defined as self-reported no smoking at all for 24 hours at the specified time point.
  • Average Number of Quit Attempts Per Arm [ Time Frame: 4 month follow up ]
    Average number of quit attempts per group defined as self-reported no smoking at all for 24 hours at the specified time point.
  • Change in Nicotine Dependence as Measured by the Fagerstrom Test of Nicotine Dependence [ Time Frame: Baseline to 1, 2, 3 and 4 month follow up ]
    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"
  • Change in Average Number of Cigarettes Smoked Per Day [ Time Frame: Baseline to 1, 2, 3 and 4 month follow up ]
    Change in average number of self-reported cigarettes smoked per day per arm from baseline to the specified time point.
  • Nicotine Replacement Patch Utilization [ Time Frame: 1 month follow up ]
    Days of patch use over the last 30 days.
  • Nicotine Replacement Patch Utilization [ Time Frame: 2 month follow up ]
    Days of patch use over the last 30 days.
  • Nicotine Replacement Patch Utilization [ Time Frame: 3 month follow up ]
    Days of patch use over the last 30 days.
  • Nicotine Replacement Patch Utilization [ Time Frame: 4 month follow up ]
    Days of patch use over the last 30 days.
  • Nicotine Replacement Lozenge Utilization [ Time Frame: 1 month follow up ]
    Days of lozenge use over the last 30 days.
  • Nicotine Replacement Lozenge Utilization [ Time Frame: 2 month follow up ]
    Days of lozenge use over the last 30 days.
  • Nicotine Replacement Lozenge Utilization [ Time Frame: 3 month follow up ]
    Days of lozenge use over the last 30 days.
  • Nicotine Replacement Lozenge Utilization [ Time Frame: 4 month follow up ]
    Days of lozenge use over the last 30 days.
  • Affect Ratings - Learn to Quit [ Time Frame: Daily throughout study duration, 4 months ]
    Average mood rating as self-reported through the Learn to Quit app. Ratings range from 1-10 with lower scores indicating poorer mood ratings.
  • Affect Ratings - QuitGuide [ Time Frame: Daily throughout study, 4 months ]
    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.
  • Smoking Cravings [ Time Frame: Daily throughout study duration, 4 months ]
    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.
  • Psychotic Symptoms [ Time Frame: 1 month follow up ]
    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.
  • Psychotic Symptoms [ Time Frame: 2 month follow up ]
    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.
  • Psychotic Symptoms [ Time Frame: 3 month follow up ]
    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.
  • Psychotic Symptoms [ Time Frame: 4 month follow up ]
    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.
  • General Psychiatric Symptoms [ Time Frame: 1 month follow up ]
    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.
  • General Psychiatric Symptoms [ Time Frame: 2 month follow up ]
    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.
  • General Psychiatric Symptoms [ Time Frame: 3 month follow up ]
    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.
  • General Psychiatric Symptoms [ Time Frame: 4 month follow up ]
    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.
Original Secondary Outcome Measures  ICMJE
 (submitted: March 2, 2017)
  • Biochemically Confirmed Prolonged Abstinence Rates [ Time Frame: 1 month follow up ]
    Percent of subjects in each group reporting abstinence. 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
  • Biochemically Confirmed Prolonged Abstinence Rates [ Time Frame: 2 month follow up ]
    Percent of subjects in each group reporting abstinence. 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
  • Biochemically Confirmed Prolonged Abstinence Rates [ Time Frame: 3 month follow up ]
    Percent of subjects in each group reporting abstinence. 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
  • Biochemically Confirmed Prolonged Abstinence Rates [ Time Frame: 4 month follow up ]
    Percent of subjects in each group reporting abstinence. 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
  • 30-day, 7-day, & 24-hour point prevalence abstinence rates [ Time Frame: 1 month follow up ]
    Percent of subjects in each group who self-reported not smoking any tobacco product at all during the corresponding time frame period
  • 30-day, 7-day, & 24-hour point prevalence abstinence rates [ Time Frame: 2 month follow up ]
    Percent of subjects in each group who self-reported not smoking any tobacco product at all during the corresponding time frame period
  • 30-day, 7-day, & 24-hour point prevalence abstinence rates [ Time Frame: 3 month follow up ]
    Percent of subjects in each group who self-reported not smoking any tobacco product at all during the corresponding time frame period
  • 30-day, 7-day, & 24-hour point prevalence abstinence rates [ Time Frame: 4 month follow up ]
    Percent of subjects in each group who self-reported not smoking any tobacco product at all during the corresponding time frame period
  • Quit Attempts [ Time Frame: 1 month follow up ]
    Number of quit attempts defined as self-reported no smoking at all for 24 hours
  • Quit Attempts [ Time Frame: 2 month follow up ]
    Number of quit attempts defined as self-reported no smoking at all for 24 hours
  • Quit Attempts [ Time Frame: 3 month follow up ]
    Number of quit attempts defined as self-reported no smoking at all for 24 hours
  • Quit Attempts [ Time Frame: 4 month follow up ]
    Number of quit attempts defined as self-reported no smoking at all for 24 hours
  • Change in Nicotine Dependence as Measured by the Fagerstrom Test of Nicotine Dependence [ Time Frame: Baseline to 1, 2, 3 and 4 month follow up ]
    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"
  • Change in Number of Average Cigarettes Smoked Per Day [ Time Frame: Baseline to 1, 2, 3 and 4 month follow up ]
    Participants will self-report average number of cigarettes smoked in the past week
  • Nicotine Replacement Patch Utilization [ Time Frame: 1 month follow up ]
    Percent of subjects in each group self-reporting adherence to patch directions
  • Nicotine Replacement Patch Utilization [ Time Frame: 2 month follow up ]
    Percent of subjects in each group self-reporting adherence to patch directions
  • Nicotine Replacement Patch Utilization [ Time Frame: 3 month follow up ]
    Percent of subjects in each group self-reporting adherence to patch directions
  • Nicotine Replacement Patch Utilization [ Time Frame: 4 month follow up ]
    Percent of subjects in each group self-reporting adherence to patch directions
  • Nicotine Replacement Lozenge Utilization [ Time Frame: 1 month follow up ]
    Percent of subjects in each group self-reporting adherence to nicotine lozenge directions
  • Nicotine Replacement Lozenge Utilization [ Time Frame: 2 month follow up ]
    Percent of subjects in each group self-reporting adherence to nicotine lozenge directions
  • Nicotine Replacement Lozenge Utilization [ Time Frame: 3 month follow up ]
    Percent of subjects in each group self-reporting adherence to nicotine lozenge directions
  • Nicotine Replacement Lozenge Utilization [ Time Frame: 4 month follow up ]
    Percent of subjects in each group self-reporting adherence to nicotine lozenge directions
  • Affect [ Time Frame: Daily throughout study duration, 4 months ]
    Mood ratings as self-reported through each smartphone app
  • Smoking Cravings [ Time Frame: Daily throughout study duration, 4 months ]
    Smoking cravings as self-reported through each smartphone app
  • Psychotic symptoms [ Time Frame: 1 month follow up ]
    Percent of subjects in each group with clinically interfering psychotic symptoms as determined by the Positive and Negative Syndrome Scale for Schizophrenia
  • Psychotic Symptoms [ Time Frame: 2 month follow up ]
    Percent of subjects in each group with clinically interfering psychotic symptoms as determined by the Positive and Negative Syndrome Scale for Schizophrenia
  • Psychotic Symptoms [ Time Frame: 3 month follow up ]
    Percent of subjects in each group with clinically interfering psychotic symptoms as determined by the Positive and Negative Syndrome Scale for Schizophrenia
  • Psychotic Symptoms [ Time Frame: 4 month follow up ]
    Percent of subjects in each group with clinically interfering psychotic symptoms as determined by the Positive and Negative Syndrome Scale for Schizophrenia
  • Non-psychotic psychiatric symptoms [ Time Frame: 1 month follow up ]
    Percent of subjects in each group with clinically interfering psychotic symptoms as determined by the Brief Symptom Inventory
  • Non-psychotic psychiatric symptoms [ Time Frame: 2 month follow up ]
    Percent of subjects in each group with clinically interfering psychotic symptoms as determined by the Brief Symptom Inventory
  • Non-psychotic psychiatric symptoms [ Time Frame: 3 month follow up ]
    Percent of subjects in each group with clinically interfering psychotic symptoms as determined by the Brief Symptom Inventory
  • Non-psychotic psychiatric symptoms [ Time Frame: 4 month follow up ]
    Percent of subjects in each group with clinically interfering psychotic symptoms as determined by the Brief Symptom Inventory
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Feasibility Trial of a Tailored Smoking Cessation App for People With Serious Mental Illness
Official Title  ICMJE Feasibility Trial of a Tailored Smoking Cessation App for People With Serious Mental Illness
Brief Summary

Quitting smoking has important health benefits for people with serious mental illness, more than half of whom are smokers. Smoking reductions in this population, in turn, could contribute to saving billions of dollars in healthcare expenditures.

Finding ways to deliver more effective and wider reaching smoking cessation interventions to individuals with serious mental illness is a pressing priority. Smartphone apps are a wide reaching technology that could provide a viable platform to deliver smoking cessation interventions for individuals with serious mental illness.

However, do smoking cessation apps need to be tailored for people with serious mental illness to ensure their success? Or can providers simply use standard and freely available smoking cessation mobile health treatments designed for the general population? Furthermore, is it feasible to conduct mHealth trials in this population?

Therefore, this trial will test whether (1) a tailored smoking cessation app for people with serious mental illness results in higher levels of engagement with smoking cessation content as compared to an app designed for the general population and (2) smoking cessation mHealth trials can be feasibly conducted in this population.

Detailed Description

Smoking tobacco shortens the lifespan of adults with serious mental illness by 25 years and contributes to $317 billion expenditures in healthcare, indirect loss of earnings and disability benefits. Determining whether it is possible to deliver more effective and wider reaching smoking cessation interventions to individuals with serious mental illness is a high priority. Smartphone apps are a wide reaching technology that could provide individuals with serious mental illness the necessary skills for quitting.

This feasibility trial will test whether a tailored smoking cessation app for people with serious mental illness, Learn to Quit, results in higher levels of engagement with smoking cessation content as compared to an app designed for the general population, NCI QuitGuide. The trial will also demonstrate whether it is possible to (a) feasibly recruit and retain individuals with serious mental illness in an mHealth clinical trial, and (b) successfully gather smoking cessation outcomes. Ninety individuals with serious mental illness will be randomly assigned to one of two conditions. In the experimental condition, participants will use the Learn to Quit app. In the comparator condition, participants will use the NCI QuitGuide app. Participants in both conditions will receive Nicotine Replacement Therapy (standard dosing of nicotine patch + 1-week course of 4mg nicotine lozenges) and technical coaching. Study duration will be 4 months, with four follow-up appointments at 1-month, 2-month, 3-month, and 4-months.

Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 1
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description:
Subjects will be assigned to one of two smoking cessation apps for the duration of the study: Learn to Quit or NCI QuitGuide. One app was designed to address the needs of people with serious mental illness (Learn to Quit) and the other was designed for the general population (NCI QuitGuide).
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE
  • Nicotine Addiction
  • Serious Mental Illness
Intervention  ICMJE
  • Device: Learn to Quit App
    A smartphone app designed for individuals with serious mental illness. The main intervention components of the app are skills based on an intervention called Acceptance and Commitment Therapy that will (a) teach smoking cessation skills and (b) help cope with mental health symptoms. The app incorporates gaming features to keep users engaged, and a tracking component to record smoking habits and moods.
  • Drug: Nicotine patch
    Participants enrolled in the study will be given an 8-week course of Nicotine patches. The 8-week course of trans-dermal nicotine patches starting at 21mg/24h for 4 weeks, then transitioning to 14mg/24h for 2 weeks, and finally to 7mg/24h for the last 2 weeks. This dosing will follow recommendations contained in the US DHHS Clinical Practice Guidelines.
  • Drug: Nicotine lozenge
    Each participant will be given a 1-week course of 4mg Nicotine lozenges to be taken orally as nicotine cravings arise (about 10 lozenges per day). They will be directed to use them for the week following their quit date, using no more than once every 1-2 hours. This dosing will follow recommendations contained in the US DHHS Clinical Practice Guidelines.
  • Behavioral: Technical Coaching
    Coaching to assist the user on the use of each assigned smartphone app. This coaching will be delivered by research staff following a coaching procedure. These in-person coaching meetings will be brief (~15 minutes), done on a weekly basis for 4 weeks, and will have a focus on providing technical assistance.
  • Device: NCI QuitGuide App
    A smartphone app developed by the National Cancer Institute which uses recommendations contained in the US DHHS Clinical Practice Guidelines and smokefree.gov. NCI QuitGuide has the following intervention components: (a) psycho-education about the impact of smoking in health, (b) tracking of smoking habits, and (c) Tips for quitting (e.g., distraction strategies).
Study Arms  ICMJE
  • Experimental: Learn to Quit
    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.
    Interventions:
    • Device: Learn to Quit App
    • Drug: Nicotine patch
    • Drug: Nicotine lozenge
    • Behavioral: Technical Coaching
  • Active Comparator: NCI QuitGuide
    A smartphone app developed by the National Cancer Institute which uses smoking cessation recommendations contained in the US DHHS Clinical Practice Guidelines.
    Interventions:
    • Drug: Nicotine patch
    • Drug: Nicotine lozenge
    • Behavioral: Technical Coaching
    • Device: NCI QuitGuide App
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: February 15, 2019)
63
Original Estimated Enrollment  ICMJE
 (submitted: March 2, 2017)
90
Actual Study Completion Date  ICMJE January 17, 2019
Actual Primary Completion Date January 17, 2019   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • ICD-10 diagnosis of schizophrenia, schizoaffective, bipolar or recurring depressive disorder
  • Smoking ≥ 5 cigarettes per day over the past 30 days
  • Desire to quit smoking in the next 30 days
  • Willing and medically eligible to use Nicotine Replacement Therapy
  • Fluent in spoken and written English
  • Working email, mailing address, or alternative contact person
  • Taking psychiatric medications as prescribed by their provider
  • Stable housing

Exclusion Criteria:

  • Problematic alcohol or illicit drug use in the last 30 days
  • Acute psychotic episode, unsafe to participate in the study, or psychiatrically unstable
  • Pregnant, breastfeeding, or having the intention to become pregnant in the next 4 months
  • Hearing, comprehension, or visual limitations that preclude study participation
  • Currently receiving any pharmacological and/or behavioral intervention or counseling for smoking cessation
  • Using non-cigarette forms of tobacco as the primary source of nicotine (e.g. e-cigarettes, chew)
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT03069482
Other Study ID Numbers  ICMJE Pro00075165
4R00DA037276-03 ( U.S. NIH Grant/Contract )
Has Data Monitoring Committee No
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE
Plan to Share IPD: Undecided
Responsible Party Duke University
Study Sponsor  ICMJE Duke University
Collaborators  ICMJE National Institute on Drug Abuse (NIDA)
Investigators  ICMJE
Principal Investigator: Roger Vilardaga, PhD Duke University
PRS Account Duke University
Verification Date October 2020

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP