Trial Outcomes & Findings for Improving Depression Management (NCT NCT05050227)
NCT ID: NCT05050227
Last Updated: 2025-07-20
Results Overview
The Patient Health Questionnaire (PHQ-9) is a scale commonly used to measure and categorize depression symptoms. It is already administered as part of routine primary care at our study site. The minimum score is 0, the maximum is 27. A higher score indicates a worse outcome (i.e. more severe depression symptoms).
COMPLETED
NA
57 participants
3-months
2025-07-20
Participant Flow
Participant milestones
| Measure |
cCBT Enhanced Collaborative Care
Participants in the intervention arm will receive computerized cognitive behavioral therapy (cCBT) supported by a depression care manager in addition to the usual care provided.
cCBT Enhanced Collaborative Care: Computerized CBT (cCBT) will be delivered supported by a depression care manger who will facilitate access to cCBT, promote and monitor cCBT use, reinforce CBT concepts (during outside CBT session "homework"), and monitor mental health symptoms for each participant.
|
Usual Care
Participants in the usual care arm will receive the usual care provided as described below.
Usual Care: Primary Care Provider supported usual care typically includes medication prescription and referrals to specialty mental health, including Primary Care - Mental Health Integration services.
|
|---|---|---|
|
Overall Study
STARTED
|
29
|
28
|
|
Overall Study
COMPLETED
|
21
|
21
|
|
Overall Study
NOT COMPLETED
|
8
|
7
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Improving Depression Management
Baseline characteristics by cohort
| Measure |
cCBT Enhanced Collaborative Care
n=29 Participants
Participants in the intervention arm will receive computerized cognitive behavioral therapy (cCBT) supported by a depression care manager in addition to the usual care provided.
cCBT Enhanced Collaborative Care: Computerized CBT (cCBT) will be delivered supported by a depression care manger who will facilitate access to cCBT, promote and monitor cCBT use, reinforce CBT concepts (during outside CBT session "homework"), and monitor mental health symptoms for each participant.
|
Usual Care
n=28 Participants
Participants in the usual care arm will receive the usual care provided as described below.
Usual Care: Primary Care Provider supported usual care typically includes medication prescription and referrals to specialty mental health, including Primary Care - Mental Health Integration services.
|
Total
n=57 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
24 Participants
n=5 Participants
|
22 Participants
n=7 Participants
|
46 Participants
n=5 Participants
|
|
Age, Categorical
>=65 years
|
5 Participants
n=5 Participants
|
6 Participants
n=7 Participants
|
11 Participants
n=5 Participants
|
|
Age, Continuous
|
49.9 years
STANDARD_DEVIATION 17.6 • n=5 Participants
|
49.8 years
STANDARD_DEVIATION 15.1 • n=7 Participants
|
49.9 years
STANDARD_DEVIATION 16.3 • n=5 Participants
|
|
Sex: Female, Male
Female
|
8 Participants
n=5 Participants
|
9 Participants
n=7 Participants
|
17 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
21 Participants
n=5 Participants
|
19 Participants
n=7 Participants
|
40 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
10 Participants
n=5 Participants
|
8 Participants
n=7 Participants
|
18 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
19 Participants
n=5 Participants
|
19 Participants
n=7 Participants
|
38 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Asian
|
1 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
3 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
1 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Black or African American
|
8 Participants
n=5 Participants
|
9 Participants
n=7 Participants
|
17 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
10 Participants
n=5 Participants
|
9 Participants
n=7 Participants
|
19 Participants
n=5 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
9 Participants
n=5 Participants
|
8 Participants
n=7 Participants
|
17 Participants
n=5 Participants
|
|
Region of Enrollment
United States
|
29 Participants
n=5 Participants
|
28 Participants
n=7 Participants
|
57 Participants
n=5 Participants
|
|
Patient Health Questionnaire (PHQ-9)
|
15.4 units on a scale
STANDARD_DEVIATION 4.9 • n=5 Participants
|
14.6 units on a scale
STANDARD_DEVIATION 5.2 • n=7 Participants
|
15.1 units on a scale
STANDARD_DEVIATION 5.0 • n=5 Participants
|
PRIMARY outcome
Timeframe: 3-monthsThe Patient Health Questionnaire (PHQ-9) is a scale commonly used to measure and categorize depression symptoms. It is already administered as part of routine primary care at our study site. The minimum score is 0, the maximum is 27. A higher score indicates a worse outcome (i.e. more severe depression symptoms).
Outcome measures
| Measure |
cCBT Enhanced Collaborative Care
n=21 Participants
Participants in the intervention arm will receive computerized cognitive behavioral therapy (cCBT) supported by a depression care manager in addition to the usual care provided.
cCBT Enhanced Collaborative Care: Computerized CBT (cCBT) will be delivered supported by a depression care manger who will facilitate access to cCBT, promote and monitor cCBT use, reinforce CBT concepts (during outside CBT session "homework"), and monitor mental health symptoms for each participant.
|
Usual Care
n=21 Participants
Participants in the usual care arm will receive the usual care provided as described below.
Usual Care: Primary Care Provider supported usual care typically includes medication prescription and referrals to specialty mental health, including Primary Care - Mental Health Integration services.
|
|---|---|---|
|
Patient Health Questionnaire (PHQ-9)
|
12.6 score on a scale
Standard Deviation 5.2
|
15.2 score on a scale
Standard Deviation 5.1
|
SECONDARY outcome
Timeframe: 3-monthsThe 10-item PROMIS Global Health assesses health-related quality of life and is summarized into "physical health" (physical functioning, pain, fatigue) and "mental health" (emotional problems, social functioning). Raw scores are summed (minimum score for either physical health or mental health=4, maximum score for either =20) and converted to a t-score by using a conversion table (minimum t-score for physical health=16.2, maximum =67.7; minimum t-score for mental health=21.2, maximum =67.6). A score of 50, with a standard deviation of 10, is the average for the United States general population. For both the physical and mental health, a higher score indicates a better outcome (i.e., better health). For physical health, a score of 35 or less is reflective of "poor" physical health, and 36-42 of "fair". Similarly, for mental health, a score of 29 or less is reflective of "poor" mental health, 29-40 of "fair".
Outcome measures
| Measure |
cCBT Enhanced Collaborative Care
n=21 Participants
Participants in the intervention arm will receive computerized cognitive behavioral therapy (cCBT) supported by a depression care manager in addition to the usual care provided.
cCBT Enhanced Collaborative Care: Computerized CBT (cCBT) will be delivered supported by a depression care manger who will facilitate access to cCBT, promote and monitor cCBT use, reinforce CBT concepts (during outside CBT session "homework"), and monitor mental health symptoms for each participant.
|
Usual Care
n=21 Participants
Participants in the usual care arm will receive the usual care provided as described below.
Usual Care: Primary Care Provider supported usual care typically includes medication prescription and referrals to specialty mental health, including Primary Care - Mental Health Integration services.
|
|---|---|---|
|
PROMIS Global Health
Physical Health
|
38.3 t-score
Standard Deviation 7.1
|
38.7 t-score
Standard Deviation 8.4
|
|
PROMIS Global Health
Mental Health
|
36.9 t-score
Standard Deviation 6.1
|
38.2 t-score
Standard Deviation 6.5
|
SECONDARY outcome
Timeframe: 3-monthsThe 7-item Generalized Anxiety Disorder (GAD-7) is among the most commonly used and best validated anxiety measures in primary care settings. The minimum score is 0, the maximum is 21. Higher scores indicate a worse outcome (i.e., more severe anxiety). For reference: scores of 0-4=minimal anxiety, 5-9=mild anxiety, 10-14=moderate anxiety, and 15-21=severe anxiety.
Outcome measures
| Measure |
cCBT Enhanced Collaborative Care
n=21 Participants
Participants in the intervention arm will receive computerized cognitive behavioral therapy (cCBT) supported by a depression care manager in addition to the usual care provided.
cCBT Enhanced Collaborative Care: Computerized CBT (cCBT) will be delivered supported by a depression care manger who will facilitate access to cCBT, promote and monitor cCBT use, reinforce CBT concepts (during outside CBT session "homework"), and monitor mental health symptoms for each participant.
|
Usual Care
n=21 Participants
Participants in the usual care arm will receive the usual care provided as described below.
Usual Care: Primary Care Provider supported usual care typically includes medication prescription and referrals to specialty mental health, including Primary Care - Mental Health Integration services.
|
|---|---|---|
|
Generalized Anxiety Disorder (GAD-7)
|
9.6 score on a scale
Standard Deviation 5.8
|
10.6 score on a scale
Standard Deviation 5.2
|
SECONDARY outcome
Timeframe: 3-monthsThe 13-item Patient Activation Measure (PAM) will be used to assess an individual's knowledge, skill, and confidence for self-management. The minimum score is 0, the maximum is 100. Higher scores indicate a better outcome (i.e., higher patient activation).
Outcome measures
| Measure |
cCBT Enhanced Collaborative Care
n=21 Participants
Participants in the intervention arm will receive computerized cognitive behavioral therapy (cCBT) supported by a depression care manager in addition to the usual care provided.
cCBT Enhanced Collaborative Care: Computerized CBT (cCBT) will be delivered supported by a depression care manger who will facilitate access to cCBT, promote and monitor cCBT use, reinforce CBT concepts (during outside CBT session "homework"), and monitor mental health symptoms for each participant.
|
Usual Care
n=21 Participants
Participants in the usual care arm will receive the usual care provided as described below.
Usual Care: Primary Care Provider supported usual care typically includes medication prescription and referrals to specialty mental health, including Primary Care - Mental Health Integration services.
|
|---|---|---|
|
Patient Activation Measure (PAM)
|
37.5 score on a scale
Standard Deviation 4.2
|
38.6 score on a scale
Standard Deviation 5.4
|
SECONDARY outcome
Timeframe: 3-monthsThe PTSD Checklist for DSM-5 (PCL-5) is a 20-item self-reported measure that will be used to assesses PTSD symptoms and symptom change. The minimum score is 0, the maximum is 80. Higher score indicate a worse outcome (i.e., more severe PTSD symptoms).
Outcome measures
| Measure |
cCBT Enhanced Collaborative Care
n=21 Participants
Participants in the intervention arm will receive computerized cognitive behavioral therapy (cCBT) supported by a depression care manager in addition to the usual care provided.
cCBT Enhanced Collaborative Care: Computerized CBT (cCBT) will be delivered supported by a depression care manger who will facilitate access to cCBT, promote and monitor cCBT use, reinforce CBT concepts (during outside CBT session "homework"), and monitor mental health symptoms for each participant.
|
Usual Care
n=21 Participants
Participants in the usual care arm will receive the usual care provided as described below.
Usual Care: Primary Care Provider supported usual care typically includes medication prescription and referrals to specialty mental health, including Primary Care - Mental Health Integration services.
|
|---|---|---|
|
PTSD Checklist for DSM-5 (PCL-5)
|
30.1 score on a scale
Standard Deviation 19.5
|
34.0 score on a scale
Standard Deviation 16.7
|
SECONDARY outcome
Timeframe: 3-monthsThe 9-item Behavioral Activation for Depression Scale (BADS-SF) will also be used to examine behavioral activation as an intermediary to depression symptomatology outcomes. The minimum score is 0, the maximum is 54. Higher scores indicate a better outcome (i.e., higher activation).
Outcome measures
| Measure |
cCBT Enhanced Collaborative Care
n=21 Participants
Participants in the intervention arm will receive computerized cognitive behavioral therapy (cCBT) supported by a depression care manager in addition to the usual care provided.
cCBT Enhanced Collaborative Care: Computerized CBT (cCBT) will be delivered supported by a depression care manger who will facilitate access to cCBT, promote and monitor cCBT use, reinforce CBT concepts (during outside CBT session "homework"), and monitor mental health symptoms for each participant.
|
Usual Care
n=21 Participants
Participants in the usual care arm will receive the usual care provided as described below.
Usual Care: Primary Care Provider supported usual care typically includes medication prescription and referrals to specialty mental health, including Primary Care - Mental Health Integration services.
|
|---|---|---|
|
Behavioral Activation for Depression Scale (BADS-SF)
|
21.4 score on a scale
Standard Deviation 9.1
|
22.6 score on a scale
Standard Deviation 7.8
|
OTHER_PRE_SPECIFIED outcome
Timeframe: 3-monthsPopulation: Usual care participants were not given the opportunity to use the cCBT program.
Treatment engagement will be conceptualized as the number of cCBT sessions completed. The minimum number of sessions is 0 and the maximum is 11. A higher number indicates more cCBT sessions completed, but isn't indicative of a better or worse outcome.
Outcome measures
| Measure |
cCBT Enhanced Collaborative Care
n=29 Participants
Participants in the intervention arm will receive computerized cognitive behavioral therapy (cCBT) supported by a depression care manager in addition to the usual care provided.
cCBT Enhanced Collaborative Care: Computerized CBT (cCBT) will be delivered supported by a depression care manger who will facilitate access to cCBT, promote and monitor cCBT use, reinforce CBT concepts (during outside CBT session "homework"), and monitor mental health symptoms for each participant.
|
Usual Care
Participants in the usual care arm will receive the usual care provided as described below.
Usual Care: Primary Care Provider supported usual care typically includes medication prescription and referrals to specialty mental health, including Primary Care - Mental Health Integration services.
|
|---|---|---|
|
Treatment Engagement
|
6.7 number of sessions
Standard Deviation 4.9
|
—
|
Adverse Events
cCBT Enhanced Collaborative Care
Usual Care
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Lucinda B. Leung, MD, PhD, MPH
VA Greater Los Angeles Healthcare System, UCLA David Geffen School of Medicine
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place