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IntelliCare: Artificial Intelligence in a Mobile Intervention for Depression and Anxiety (AIM)

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ClinicalTrials.gov Identifier: NCT02176226
Recruitment Status : Completed
First Posted : June 27, 2014
Results First Posted : October 29, 2018
Last Update Posted : October 29, 2018
Sponsor:
Information provided by (Responsible Party):
David Mohr, Northwestern University

Study Type Interventional
Study Design Intervention Model: Single Group Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Conditions Major Depressive Disorder
Anxiety Disorders
Intervention Behavioral: IntelliCare
Enrollment 105
Recruitment Details  
Pre-assignment Details  
Arm/Group Title 8-Week Single Arm Field Trial
Hide Arm/Group Description

Use of IntelliCare program for 8 weeks.

IntelliCare: Behavioral interventions for depression and anxiety via a suite of mobile phone applications, IntelliCare.

Period Title: Overall Study
Started 105
Completed 96
Not Completed 9
Reason Not Completed
Lost to Follow-up             3
Withdrew prior to treatment             6
Arm/Group Title 8-Week Single Arm Field Trial
Hide Arm/Group Description

Use of IntelliCare program for 8 weeks.

IntelliCare: Behavioral interventions for depression and anxiety via a mobile phone application, IntelliCare.

Overall Number of Baseline Participants 105
Hide Baseline Analysis Population Description
[Not Specified]
Age, Continuous  
Median (Inter-Quartile Range)
Unit of measure:  Years
Number Analyzed 105 participants
36
(27 to 50)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 105 participants
Female
80
  76.2%
Male
25
  23.8%
Ethnicity (NIH/OMB)  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 105 participants
Hispanic or Latino
5
   4.8%
Not Hispanic or Latino
99
  94.3%
Unknown or Not Reported
1
   1.0%
Race (NIH/OMB)  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 105 participants
American Indian or Alaska Native
1
   1.0%
Asian
6
   5.7%
Native Hawaiian or Other Pacific Islander
0
   0.0%
Black or African American
8
   7.6%
White
88
  83.8%
More than one race
1
   1.0%
Unknown or Not Reported
1
   1.0%
Marital Status  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 105 participants
Single
35
  33.3%
Married or domestic partner
38
  36.2%
Separated
1
   1.0%
Divorced
13
  12.4%
Widowed
3
   2.9%
Living with significant other
15
  14.3%
Education  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 105 participants
Some high school
1
   1.0%
Completed high school or GED
4
   3.8%
Some college
20
  19.0%
2-year college (Associate)
16
  15.2%
4-year college (BA, BS)
37
  35.2%
Master's degree
22
  21.0%
Doctoral degree
4
   3.8%
Professional degree (MD, JD)
1
   1.0%
Employment status  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 105 participants
Employed
76
  72.4%
Unemployed
11
  10.5%
Disability
8
   7.6%
Retired
5
   4.8%
Other
5
   4.8%
Number of hours per week spent working  
Median (Inter-Quartile Range)
Unit of measure:  Hours per week spent working
Number Analyzed 105 participants
40
(7 to 40)
Income, yearly household income  
Median (Inter-Quartile Range)
Unit of measure:  USD
Number Analyzed 105 participants
63,000
(30,000 to 100,000)
Income, yearly personal gross income  
Median (Inter-Quartile Range)
Unit of measure:  USD
Number Analyzed 105 participants
35,000
(15,000 to 58,000)
Treatment  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 105 participants
Psychotherapy
23
  21.9%
Pharmacotherapy
66
  62.9%
None
16
  15.2%
Recruitment Source  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 105 participants
HealthPartners Healthcare system
38
  36.2%
Web or social media
16
  15.2%
ResearchMatch
11
  10.5%
Other
40
  38.1%
1.Primary Outcome
Title Patient Health Questionnaire - 9 (PHQ-9) - Depression Severity Module
Hide Description The PHQ-9 measures degree of depression severity. Possible range of scores for the PHQ-9 is 0-27. Higher values represent a worse outcome. Specifically, scores of 0-4 indicate minimal or no depression; 5-9 is mild; 10-14 is moderate; 15-19 is moderately severe; and 20-27 is severe.
Time Frame Baseline, Week 4, and Week 8
Hide Outcome Measure Data
Hide Analysis Population Description
Two participants missed week 4 assessment; and two participants missed week 8 assessment. This is why number analyzed in Week 4 row and Week 8 row differs from overall.
Arm/Group Title 8-Week Single Arm Field Trial
Hide Arm/Group Description:

Use of IntelliCare program for 8 weeks.

IntelliCare: Behavioral interventions for depression and anxiety via a suite of mobile phone applications, IntelliCare.

Overall Number of Participants Analyzed 96
Mean (Standard Deviation)
Unit of Measure: units on a scale
Baseline Number Analyzed 96 participants
12.5  (4.3)
Week 4 Number Analyzed 94 participants
8.4  (4.1)
Week 8 Number Analyzed 94 participants
6.4  (4.3)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection 8-Week Single Arm Field Trial
Comments [Not Specified]
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <.001
Comments [Not Specified]
Method t-test, 2 sided
Comments [Not Specified]
2.Primary Outcome
Title GAD-7 (Generalized Anxiety Disorder Scale-7)
Hide Description The GAD-7 is a self-administered 7 item instrument that uses some of the DSM-V criteria for GAD (General Anxiety Disorder) to identify probable cases of GAD along with measuring anxiety symptom severity. GAD-7 total score for the seven items ranges from 0 to 21. Higher values represent a worse outcome. Specifically, scores of 1-4 indicate minimal anxiety symptoms; 5-9 is mild anxiety symptoms; 10-14 is moderate anxiety symptoms; and 15-21 is severe anxiety symptoms.
Time Frame Baseline, Week 4, and Week 8
Hide Outcome Measure Data
Hide Analysis Population Description
Two participants missed week 4 assessment; and two participants missed week 8 assessment. This is why number analyzed in Week 4 row and Week 8 row differs from overall.
Arm/Group Title 8-Week Single Arm Field Trial
Hide Arm/Group Description:

Use of IntelliCare program for 8 weeks.

IntelliCare: Behavioral interventions for depression and anxiety via a suite of mobile phone applications, IntelliCare.

Overall Number of Participants Analyzed 96
Mean (Standard Deviation)
Unit of Measure: units on a scale
Baseline Number Analyzed 96 participants
10.9  (4.5)
Week 4 Number Analyzed 94 participants
7.1  (3.9)
Week 8 Number Analyzed 94 participants
5.8  (4.0)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection 8-Week Single Arm Field Trial
Comments [Not Specified]
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <.001
Comments [Not Specified]
Method t-test, 2 sided
Comments [Not Specified]
3.Secondary Outcome
Title Mean Number of Treatment App Use Sessions by Study Week
Hide Description [Not Specified]
Time Frame Weekly for Two Months
Hide Outcome Measure Data
Hide Analysis Population Description
Of the 99 participants who initiated the treatment, 96.0% (95/99) continued to use the apps at week 5 and 90.1% (90/99) continued through week 8.
Arm/Group Title 8-Week Single Arm Field Trial
Hide Arm/Group Description:

Use of IntelliCare program for 8 weeks.

IntelliCare: Behavioral interventions for depression and anxiety via a suite of mobile phone applications, IntelliCare.

Overall Number of Participants Analyzed 98
Mean (Standard Deviation)
Unit of Measure: number of treatment app use sessions
Week 1 Number Analyzed 98 participants
20.09  (15.63)
Week 2 Number Analyzed 97 participants
22.79  (16.76)
Week 3 Number Analyzed 97 participants
24.1  (20.21)
Week 4 Number Analyzed 94 participants
25.33  (20.68)
Week 5 Number Analyzed 94 participants
26.07  (20.41)
Week 6 Number Analyzed 91 participants
26.25  (23.66)
Week 7 Number Analyzed 89 participants
23.44  (22.27)
Week 8 Number Analyzed 90 participants
23.3  (25.57)
Time Frame 8 weeks
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title 8-Week Single Arm Field Trial
Hide Arm/Group Description

Use of IntelliCare program for 8 weeks.

IntelliCare: Behavioral interventions for depression and anxiety via a suite of mobile phone applications, IntelliCare.

All-Cause Mortality
8-Week Single Arm Field Trial
Affected / at Risk (%)
Total   --/-- 
Show Serious Adverse Events Hide Serious Adverse Events
8-Week Single Arm Field Trial
Affected / at Risk (%)
Total   0/105 (0.00%) 
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 0%
8-Week Single Arm Field Trial
Affected / at Risk (%)
Total   0/105 (0.00%) 
Certain Agreements
All Principal Investigators ARE employed by the organization sponsoring the study.
Results Point of Contact
Layout table for Results Point of Contact information
Name/Title: David C. Mohr, PhD
Organization: Northwestern University
Phone: 312-503-1403
EMail: d-mohr@northwestern.edu
Layout table for additonal information
Responsible Party: David Mohr, Northwestern University
ClinicalTrials.gov Identifier: NCT02176226     History of Changes
Other Study ID Numbers: R01MH100482-01FTIC ( U.S. NIH Grant/Contract )
First Submitted: June 25, 2014
First Posted: June 27, 2014
Results First Submitted: August 2, 2017
Results First Posted: October 29, 2018
Last Update Posted: October 29, 2018