Trial Outcomes & Findings for IntelliCare Study: Artificial Intelligence in a Mobile (AIM) Intervention for Depression (NCT NCT02801877)
NCT ID: NCT02801877
Last Updated: 2023-04-04
Results Overview
Defined as the median time to last engagement with the mobile application suite within 8 weeks of trial
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
301 participants
Primary outcome timeframe
Participants will be followed for the duration of the 8 week trial
Results posted on
2023-04-04
Participant Flow
Participant milestones
| Measure |
IntelliCare Hub Recommender, Coach
Participant is randomly assigned to receive the IntelliCare Hub App with the recommender system, and receive coaching for the 8 week IntelliCare program.
IntelliCare
Hub App with the Recommender System
Coaching
|
IntelliCare Hub Recommender, no Coach
Participant is randomly assigned to receive the IntelliCare Hub App with the recommender system, and independently use the IntelliCare program for 8 weeks.
IntelliCare
Hub App with the Recommender System
|
IntelliCare Hub no Recommender, Coach
Participant is randomly assigned to receive the IntelliCare Hub App without the recommender system, and receive coaching for the 8 week IntelliCare program.
IntelliCare
Coaching
|
IntelliCare Hub no Recommender, no Coach
Participant is randomly assigned to receive the IntelliCare Hub App without the recommender system, and independently use the IntelliCare program for 8 weeks.
IntelliCare
|
|---|---|---|---|---|
|
Overall Study
STARTED
|
74
|
75
|
76
|
76
|
|
Overall Study
COMPLETED
|
71
|
74
|
70
|
76
|
|
Overall Study
NOT COMPLETED
|
3
|
1
|
6
|
0
|
Reasons for withdrawal
| Measure |
IntelliCare Hub Recommender, Coach
Participant is randomly assigned to receive the IntelliCare Hub App with the recommender system, and receive coaching for the 8 week IntelliCare program.
IntelliCare
Hub App with the Recommender System
Coaching
|
IntelliCare Hub Recommender, no Coach
Participant is randomly assigned to receive the IntelliCare Hub App with the recommender system, and independently use the IntelliCare program for 8 weeks.
IntelliCare
Hub App with the Recommender System
|
IntelliCare Hub no Recommender, Coach
Participant is randomly assigned to receive the IntelliCare Hub App without the recommender system, and receive coaching for the 8 week IntelliCare program.
IntelliCare
Coaching
|
IntelliCare Hub no Recommender, no Coach
Participant is randomly assigned to receive the IntelliCare Hub App without the recommender system, and independently use the IntelliCare program for 8 weeks.
IntelliCare
|
|---|---|---|---|---|
|
Overall Study
Lost to Follow-up
|
1
|
1
|
2
|
0
|
|
Overall Study
Never Started Treatment
|
2
|
0
|
4
|
0
|
Baseline Characteristics
Participants were provided option to not answer, or to answer not applicable.
Baseline characteristics by cohort
| Measure |
IntelliCare Hub Recommender, Coach
n=74 Participants
Participant is randomly assigned to receive the IntelliCare Hub App with the recommender system, and receive coaching for the 8 week IntelliCare program.
IntelliCare
Hub App with the Recommender System
Coaching
|
IntelliCare Hub Recommender, no Coach
n=75 Participants
Participant is randomly assigned to receive the IntelliCare Hub App with the recommender system, and independently use the IntelliCare program for 8 weeks.
IntelliCare
Hub App with the Recommender System
|
IntelliCare Hub no Recommender, Coach
n=76 Participants
Participant is randomly assigned to receive the IntelliCare Hub App without the recommender system, and receive coaching for the 8 week IntelliCare program.
IntelliCare
Coaching
|
IntelliCare Hub no Recommender, no Coach
n=76 Participants
Participant is randomly assigned to receive the IntelliCare Hub App without the recommender system, and independently use the IntelliCare program for 8 weeks.
IntelliCare
|
Total
n=301 Participants
Total of all reporting groups
|
|---|---|---|---|---|---|
|
Age, Continuous
|
37.6 years
STANDARD_DEVIATION 12.2 • n=74 Participants
|
36.2 years
STANDARD_DEVIATION 11.5 • n=75 Participants
|
37.1 years
STANDARD_DEVIATION 12.3 • n=76 Participants
|
35.3 years
STANDARD_DEVIATION 11.5 • n=76 Participants
|
36.5 years
STANDARD_DEVIATION 11.8 • n=301 Participants
|
|
Sex: Female, Male
Female
|
57 Participants
n=72 Participants • Participants were provided option to not answer, or to answer not applicable.
|
54 Participants
n=75 Participants • Participants were provided option to not answer, or to answer not applicable.
|
62 Participants
n=76 Participants • Participants were provided option to not answer, or to answer not applicable.
|
55 Participants
n=76 Participants • Participants were provided option to not answer, or to answer not applicable.
|
228 Participants
n=299 Participants • Participants were provided option to not answer, or to answer not applicable.
|
|
Sex: Female, Male
Male
|
15 Participants
n=72 Participants • Participants were provided option to not answer, or to answer not applicable.
|
21 Participants
n=75 Participants • Participants were provided option to not answer, or to answer not applicable.
|
14 Participants
n=76 Participants • Participants were provided option to not answer, or to answer not applicable.
|
21 Participants
n=76 Participants • Participants were provided option to not answer, or to answer not applicable.
|
71 Participants
n=299 Participants • Participants were provided option to not answer, or to answer not applicable.
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
10 Participants
n=74 Participants
|
8 Participants
n=75 Participants
|
7 Participants
n=76 Participants
|
5 Participants
n=76 Participants
|
30 Participants
n=301 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
62 Participants
n=74 Participants
|
67 Participants
n=75 Participants
|
68 Participants
n=76 Participants
|
71 Participants
n=76 Participants
|
268 Participants
n=301 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
2 Participants
n=74 Participants
|
0 Participants
n=75 Participants
|
1 Participants
n=76 Participants
|
0 Participants
n=76 Participants
|
3 Participants
n=301 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=74 Participants
|
0 Participants
n=75 Participants
|
0 Participants
n=76 Participants
|
0 Participants
n=76 Participants
|
0 Participants
n=301 Participants
|
|
Race (NIH/OMB)
Asian
|
3 Participants
n=74 Participants
|
0 Participants
n=75 Participants
|
5 Participants
n=76 Participants
|
2 Participants
n=76 Participants
|
10 Participants
n=301 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=74 Participants
|
0 Participants
n=75 Participants
|
0 Participants
n=76 Participants
|
0 Participants
n=76 Participants
|
0 Participants
n=301 Participants
|
|
Race (NIH/OMB)
Black or African American
|
10 Participants
n=74 Participants
|
5 Participants
n=75 Participants
|
8 Participants
n=76 Participants
|
6 Participants
n=76 Participants
|
29 Participants
n=301 Participants
|
|
Race (NIH/OMB)
White
|
57 Participants
n=74 Participants
|
63 Participants
n=75 Participants
|
57 Participants
n=76 Participants
|
60 Participants
n=76 Participants
|
237 Participants
n=301 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=74 Participants
|
0 Participants
n=75 Participants
|
0 Participants
n=76 Participants
|
0 Participants
n=76 Participants
|
0 Participants
n=301 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
4 Participants
n=74 Participants
|
7 Participants
n=75 Participants
|
6 Participants
n=76 Participants
|
8 Participants
n=76 Participants
|
25 Participants
n=301 Participants
|
|
Patient Health Questionaire 9 (PHQ-9)
|
12.78 units on a scale
STANDARD_DEVIATION 4.45 • n=74 Participants
|
13.24 units on a scale
STANDARD_DEVIATION 4.55 • n=75 Participants
|
13.11 units on a scale
STANDARD_DEVIATION 4.75 • n=76 Participants
|
13.70 units on a scale
STANDARD_DEVIATION 4.79 • n=76 Participants
|
13.21 units on a scale
STANDARD_DEVIATION 4.63 • n=301 Participants
|
|
Generalized Anxiety Disorder 7 (GAD-7)
|
11.86 units on a scale
STANDARD_DEVIATION 4.05 • n=74 Participants
|
11.88 units on a scale
STANDARD_DEVIATION 3.85 • n=75 Participants
|
12.33 units on a scale
STANDARD_DEVIATION 4.51 • n=76 Participants
|
11.84 units on a scale
STANDARD_DEVIATION 3.66 • n=76 Participants
|
11.98 units on a scale
STANDARD_DEVIATION 4.02 • n=301 Participants
|
PRIMARY outcome
Timeframe: Participants will be followed for the duration of the 8 week trialDefined as the median time to last engagement with the mobile application suite within 8 weeks of trial
Outcome measures
| Measure |
IntelliCare Hub Recommender, Coach
n=74 Participants
Participant is randomly assigned to receive the IntelliCare Hub App with the recommender system, and receive coaching for the 8 week IntelliCare program.
IntelliCare
Hub App with the Recommender System
Coaching
|
IntelliCare Hub Recommender, no Coach
n=75 Participants
Participant is randomly assigned to receive the IntelliCare Hub App with the recommender system, and independently use the IntelliCare program for 8 weeks.
IntelliCare
Hub App with the Recommender System
|
IntelliCare Hub no Recommender, Coach
n=76 Participants
Participant is randomly assigned to receive the IntelliCare Hub App without the recommender system, and receive coaching for the 8 week IntelliCare program.
IntelliCare
Coaching
|
IntelliCare Hub no Recommender, no Coach
n=76 Participants
Participant is randomly assigned to receive the IntelliCare Hub App without the recommender system, and independently use the IntelliCare program for 8 weeks.
IntelliCare
|
|---|---|---|---|---|
|
Adherence to the Mobile Application Intervention
|
56 days
Interval 56.0 to 56.0
|
56 days
Interval 56.0 to 56.0
|
56 days
Interval 55.0 to 56.0
|
56 days
Interval 53.0 to 56.0
|
PRIMARY outcome
Timeframe: Measured at start of treatment (baseline), week 4, week 8, month 3, and month 6.Population: Participants with at least one follow-up measure of self-reported depression
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.
Outcome measures
| Measure |
IntelliCare Hub Recommender, Coach
n=71 Participants
Participant is randomly assigned to receive the IntelliCare Hub App with the recommender system, and receive coaching for the 8 week IntelliCare program.
IntelliCare
Hub App with the Recommender System
Coaching
|
IntelliCare Hub Recommender, no Coach
n=74 Participants
Participant is randomly assigned to receive the IntelliCare Hub App with the recommender system, and independently use the IntelliCare program for 8 weeks.
IntelliCare
Hub App with the Recommender System
|
IntelliCare Hub no Recommender, Coach
n=70 Participants
Participant is randomly assigned to receive the IntelliCare Hub App without the recommender system, and receive coaching for the 8 week IntelliCare program.
IntelliCare
Coaching
|
IntelliCare Hub no Recommender, no Coach
n=76 Participants
Participant is randomly assigned to receive the IntelliCare Hub App without the recommender system, and independently use the IntelliCare program for 8 weeks.
IntelliCare
|
|---|---|---|---|---|
|
Patient Health Questionnaire - 9 (PHQ-9) - Depression Severity
Week 4
|
8.87 score on a scale
Standard Error 0.52
|
9.43 score on a scale
Standard Error 0.51
|
8.82 score on a scale
Standard Error 0.53
|
8.89 score on a scale
Standard Error 0.51
|
|
Patient Health Questionnaire - 9 (PHQ-9) - Depression Severity
Week 8
|
6.58 score on a scale
Standard Error 0.52
|
7.90 score on a scale
Standard Error 0.51
|
7.76 score on a scale
Standard Error 0.53
|
8.20 score on a scale
Standard Error 0.51
|
|
Patient Health Questionnaire - 9 (PHQ-9) - Depression Severity
Month 3 (post treatment)
|
6.52 score on a scale
Standard Error 0.52
|
7.73 score on a scale
Standard Error 0.51
|
7.62 score on a scale
Standard Error 0.53
|
8.31 score on a scale
Standard Error 0.51
|
|
Patient Health Questionnaire - 9 (PHQ-9) - Depression Severity
Month 6 (post treatment)
|
6.84 score on a scale
Standard Error 0.53
|
8.35 score on a scale
Standard Error 0.51
|
7.33 score on a scale
Standard Error 0.53
|
7.72 score on a scale
Standard Error 0.51
|
PRIMARY outcome
Timeframe: Measured at start of treatment (baseline), week 4, week 8, month 3, and month 6.Population: Participants with at least one follow-up measure of self-reported anxiety
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.
Outcome measures
| Measure |
IntelliCare Hub Recommender, Coach
n=71 Participants
Participant is randomly assigned to receive the IntelliCare Hub App with the recommender system, and receive coaching for the 8 week IntelliCare program.
IntelliCare
Hub App with the Recommender System
Coaching
|
IntelliCare Hub Recommender, no Coach
n=74 Participants
Participant is randomly assigned to receive the IntelliCare Hub App with the recommender system, and independently use the IntelliCare program for 8 weeks.
IntelliCare
Hub App with the Recommender System
|
IntelliCare Hub no Recommender, Coach
n=70 Participants
Participant is randomly assigned to receive the IntelliCare Hub App without the recommender system, and receive coaching for the 8 week IntelliCare program.
IntelliCare
Coaching
|
IntelliCare Hub no Recommender, no Coach
n=76 Participants
Participant is randomly assigned to receive the IntelliCare Hub App without the recommender system, and independently use the IntelliCare program for 8 weeks.
IntelliCare
|
|---|---|---|---|---|
|
GAD-7 (Generalized Anxiety Disorder Scale-7) - Anxiety Severity
Week 4
|
7.66 score on a scale
Standard Error 0.49
|
8.68 score on a scale
Standard Error 0.48
|
7.67 score on a scale
Standard Error 0.48
|
7.80 score on a scale
Standard Error 0.48
|
|
GAD-7 (Generalized Anxiety Disorder Scale-7) - Anxiety Severity
Week 8
|
6.14 score on a scale
Standard Error 0.49
|
7.68 score on a scale
Standard Error 0.48
|
6.88 score on a scale
Standard Error 0.48
|
7.04 score on a scale
Standard Error 0.48
|
|
GAD-7 (Generalized Anxiety Disorder Scale-7) - Anxiety Severity
Month 3 (post treatment)
|
5.70 score on a scale
Standard Error 0.49
|
7.28 score on a scale
Standard Error 0.48
|
6.45 score on a scale
Standard Error 0.48
|
6.90 score on a scale
Standard Error 0.49
|
|
GAD-7 (Generalized Anxiety Disorder Scale-7) - Anxiety Severity
Month 6 (post treatment)
|
6.09 score on a scale
Standard Error 0.49
|
6.99 score on a scale
Standard Error 0.49
|
6.00 score on a scale
Standard Error 0.48
|
6.83 score on a scale
Standard Error 0.48
|
Adverse Events
IntelliCare Hub Recommender, Coach
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
IntelliCare Hub Recommender, no Coach
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
IntelliCare Hub no Recommender, Coach
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
IntelliCare Hub no Recommender, no Coach
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place