Trial Outcomes & Findings for IntelliCare: Artificial Intelligence in a Mobile Intervention for Depression and Anxiety (AIM) (NCT NCT02176226)
NCT ID: NCT02176226
Last Updated: 2023-04-26
Results Overview
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.
COMPLETED
NA
105 participants
Baseline, Week 4, and Week 8
2023-04-26
Participant Flow
Participant milestones
| Measure |
8-Week Single Arm Field Trial
Use of IntelliCare program for 8 weeks.
IntelliCare: Behavioral interventions for depression and anxiety via a suite of mobile phone applications, IntelliCare.
|
|---|---|
|
Overall Study
STARTED
|
105
|
|
Overall Study
COMPLETED
|
96
|
|
Overall Study
NOT COMPLETED
|
9
|
Reasons for withdrawal
| Measure |
8-Week Single Arm Field Trial
Use of IntelliCare program for 8 weeks.
IntelliCare: Behavioral interventions for depression and anxiety via a suite of mobile phone applications, IntelliCare.
|
|---|---|
|
Overall Study
Lost to Follow-up
|
3
|
|
Overall Study
Withdrew prior to treatment
|
6
|
Baseline Characteristics
IntelliCare: Artificial Intelligence in a Mobile Intervention for Depression and Anxiety (AIM)
Baseline characteristics by cohort
| Measure |
8-Week Single Arm Field Trial
n=105 Participants
Use of IntelliCare program for 8 weeks.
IntelliCare: Behavioral interventions for depression and anxiety via a mobile phone application, IntelliCare.
|
|---|---|
|
Age, Continuous
|
36 years
n=5 Participants
|
|
Sex: Female, Male
Female
|
80 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
25 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
5 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
99 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
1 Participants
n=5 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
1 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Asian
|
6 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Black or African American
|
8 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
88 Participants
n=5 Participants
|
|
Race (NIH/OMB)
More than one race
|
1 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
1 Participants
n=5 Participants
|
|
Marital Status
Single
|
35 Participants
n=5 Participants
|
|
Marital Status
Married or domestic partner
|
38 Participants
n=5 Participants
|
|
Marital Status
Separated
|
1 Participants
n=5 Participants
|
|
Marital Status
Divorced
|
13 Participants
n=5 Participants
|
|
Marital Status
Widowed
|
3 Participants
n=5 Participants
|
|
Marital Status
Living with significant other
|
15 Participants
n=5 Participants
|
|
Education
Some high school
|
1 Participants
n=5 Participants
|
|
Education
Completed high school or GED
|
4 Participants
n=5 Participants
|
|
Education
Some college
|
20 Participants
n=5 Participants
|
|
Education
2-year college (Associate)
|
16 Participants
n=5 Participants
|
|
Education
4-year college (BA, BS)
|
37 Participants
n=5 Participants
|
|
Education
Master's degree
|
22 Participants
n=5 Participants
|
|
Education
Doctoral degree
|
4 Participants
n=5 Participants
|
|
Education
Professional degree (MD, JD)
|
1 Participants
n=5 Participants
|
|
Employment status
Employed
|
76 Participants
n=5 Participants
|
|
Employment status
Unemployed
|
11 Participants
n=5 Participants
|
|
Employment status
Disability
|
8 Participants
n=5 Participants
|
|
Employment status
Retired
|
5 Participants
n=5 Participants
|
|
Employment status
Other
|
5 Participants
n=5 Participants
|
|
Number of hours per week spent working
|
40 hours per week spent working
n=5 Participants
|
|
Income, yearly household income
|
63,000 USD
n=5 Participants
|
|
Income, yearly personal gross income
|
35,000 USD
n=5 Participants
|
|
Treatment
Psychotherapy
|
23 Participants
n=5 Participants
|
|
Treatment
Pharmacotherapy
|
66 Participants
n=5 Participants
|
|
Treatment
None
|
16 Participants
n=5 Participants
|
|
Recruitment Source
HealthPartners Healthcare system
|
38 Participants
n=5 Participants
|
|
Recruitment Source
Web or social media
|
16 Participants
n=5 Participants
|
|
Recruitment Source
ResearchMatch
|
11 Participants
n=5 Participants
|
|
Recruitment Source
Other
|
40 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: Baseline, Week 4, and Week 8Population: 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.
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 |
8-Week Single Arm Field Trial
n=96 Participants
Use of IntelliCare program for 8 weeks.
IntelliCare: Behavioral interventions for depression and anxiety via a suite of mobile phone applications, IntelliCare.
|
|---|---|
|
Patient Health Questionnaire - 9 (PHQ-9) - Depression Severity Module
Baseline
|
12.5 units on a scale
Standard Deviation 4.3
|
|
Patient Health Questionnaire - 9 (PHQ-9) - Depression Severity Module
Week 4
|
8.4 units on a scale
Standard Deviation 4.1
|
|
Patient Health Questionnaire - 9 (PHQ-9) - Depression Severity Module
Week 8
|
6.4 units on a scale
Standard Deviation 4.3
|
PRIMARY outcome
Timeframe: Baseline, Week 4, and Week 8Population: 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.
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 |
8-Week Single Arm Field Trial
n=96 Participants
Use of IntelliCare program for 8 weeks.
IntelliCare: Behavioral interventions for depression and anxiety via a suite of mobile phone applications, IntelliCare.
|
|---|---|
|
GAD-7 (Generalized Anxiety Disorder Scale-7)
Week 4
|
7.1 units on a scale
Standard Deviation 3.9
|
|
GAD-7 (Generalized Anxiety Disorder Scale-7)
Baseline
|
10.9 units on a scale
Standard Deviation 4.5
|
|
GAD-7 (Generalized Anxiety Disorder Scale-7)
Week 8
|
5.8 units on a scale
Standard Deviation 4.0
|
SECONDARY outcome
Timeframe: Weekly for Two MonthsPopulation: 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.
Outcome measures
| Measure |
8-Week Single Arm Field Trial
n=98 Participants
Use of IntelliCare program for 8 weeks.
IntelliCare: Behavioral interventions for depression and anxiety via a suite of mobile phone applications, IntelliCare.
|
|---|---|
|
Mean Number of Treatment App Use Sessions by Study Week
Week 1
|
20.09 number of treatment app use sessions
Standard Deviation 15.63
|
|
Mean Number of Treatment App Use Sessions by Study Week
Week 2
|
22.79 number of treatment app use sessions
Standard Deviation 16.76
|
|
Mean Number of Treatment App Use Sessions by Study Week
Week 3
|
24.1 number of treatment app use sessions
Standard Deviation 20.21
|
|
Mean Number of Treatment App Use Sessions by Study Week
Week 4
|
25.33 number of treatment app use sessions
Standard Deviation 20.68
|
|
Mean Number of Treatment App Use Sessions by Study Week
Week 5
|
26.07 number of treatment app use sessions
Standard Deviation 20.41
|
|
Mean Number of Treatment App Use Sessions by Study Week
Week 6
|
26.25 number of treatment app use sessions
Standard Deviation 23.66
|
|
Mean Number of Treatment App Use Sessions by Study Week
Week 7
|
23.44 number of treatment app use sessions
Standard Deviation 22.27
|
|
Mean Number of Treatment App Use Sessions by Study Week
Week 8
|
23.3 number of treatment app use sessions
Standard Deviation 25.57
|
Adverse Events
8-Week Single Arm Field Trial
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