Trial Outcomes & Findings for Neuroinflammation and Modulating Factors in Depression and HIV (NCT NCT04286282)
NCT ID: NCT04286282
Last Updated: 2025-01-09
Results Overview
The Patient Health Questionnaire (PHQ)-9 is a 9-item survey measuring degree of depression severity over the previous 2 weeks. Items assess how often the patient has been bothered by specific symptoms and are rated on a scale of 0 (not at all) to 3 (nearly every day). Total score is an unweighted sum of the 9 item scores, with higher scores indicating greater depression severity. a score of 0-27 is possible. We aren't reporting subscales. A score of 5+ will screen positive for mild depression, and a score of 10+ is considered a positive to screen for moderate-severe depression. change between baseline and 3 months
COMPLETED
PHASE2
109 participants
3 months
2025-01-09
Participant Flow
Participant milestones
| Measure |
Standard of Care
The first 100 participants with HIV and depression will receive standard of care including SSRI therapy.
Depression Standard of Care: Standard clinical care for depression, which may include the use of selective serotonin re-uptake inhibitors (SSRIs).
HIV Standard of Care: Standard clinical care for HIV
|
Standard of Care + Group Support Psychotherapy
The second 100 participants with HIV and depression will receive standard of care, including SSRI therapy, and group support psychotherapy.
Group Pyschotherapy: Group psychotherapy
Depression Standard of Care: Standard clinical care for depression, which may include the use of selective serotonin re-uptake inhibitors (SSRIs).
HIV Standard of Care: Standard clinical care for HIV
|
|---|---|---|
|
Overall Study
STARTED
|
62
|
47
|
|
Overall Study
COMPLETED
|
61
|
42
|
|
Overall Study
NOT COMPLETED
|
1
|
5
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Neuroinflammation and Modulating Factors in Depression and HIV
Baseline characteristics by cohort
| Measure |
Standard of Care
n=62 Participants
The first 100 participants with HIV and depression will receive standard of care including SSRI therapy.
Depression Standard of Care: Standard clinical care for depression, which may include the use of selective serotonin re-uptake inhibitors (SSRIs).
HIV Standard of Care: Standard clinical care for HIV
|
Standard of Care + Group Support Psychotherapy
n=47 Participants
The second 100 participants with HIV and depression will receive standard of care, including SSRI therapy, and group support psychotherapy.
Group Pyschotherapy: Group psychotherapy
Depression Standard of Care: Standard clinical care for depression, which may include the use of selective serotonin re-uptake inhibitors (SSRIs).
HIV Standard of Care: Standard clinical care for HIV
|
Total
n=109 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
29 YEARS
n=99 Participants
|
29 YEARS
n=107 Participants
|
29 YEARS
n=206 Participants
|
|
Sex: Female, Male
Female
|
43 Participants
n=99 Participants
|
31 Participants
n=107 Participants
|
74 Participants
n=206 Participants
|
|
Sex: Female, Male
Male
|
19 Participants
n=99 Participants
|
16 Participants
n=107 Participants
|
35 Participants
n=206 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
|
Race (NIH/OMB)
Black or African American
|
62 Participants
n=99 Participants
|
47 Participants
n=107 Participants
|
109 Participants
n=206 Participants
|
|
Race (NIH/OMB)
White
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
PRIMARY outcome
Timeframe: 3 monthsThe Patient Health Questionnaire (PHQ)-9 is a 9-item survey measuring degree of depression severity over the previous 2 weeks. Items assess how often the patient has been bothered by specific symptoms and are rated on a scale of 0 (not at all) to 3 (nearly every day). Total score is an unweighted sum of the 9 item scores, with higher scores indicating greater depression severity. a score of 0-27 is possible. We aren't reporting subscales. A score of 5+ will screen positive for mild depression, and a score of 10+ is considered a positive to screen for moderate-severe depression. change between baseline and 3 months
Outcome measures
| Measure |
Standard of Care
n=62 Participants
The first 100 participants with HIV and depression will receive standard of care including SSRI therapy.
Depression Standard of Care: Standard clinical care for depression, which may include the use of selective serotonin re-uptake inhibitors (SSRIs).
HIV Standard of Care: Standard clinical care for HIV
|
Standard of Care + Group Support Psychotherapy
n=47 Participants
The second 100 participants with HIV and depression will receive standard of care, including SSRI therapy, and group support psychotherapy.
Group Pyschotherapy: Group psychotherapy
Depression Standard of Care: Standard clinical care for depression, which may include the use of selective serotonin re-uptake inhibitors (SSRIs).
HIV Standard of Care: Standard clinical care for HIV
|
|---|---|---|
|
Change in Patient Health Questionnaire (PHQ)-9
|
5 units on a scale
Interval 2.0 to 7.0
|
7 units on a scale
Interval 5.0 to 11.0
|
PRIMARY outcome
Timeframe: 6 monthsThe Patient Health Questionnaire (PHQ)-9 is a 9-item survey measuring degree of depression severity over the previous 2 weeks. Items assess how often the patient has been bothered by specific symptoms and are rated on a scale of 0 (not at all) to 3 (nearly every day). Total score is an unweighted sum of the 9 item scores, with higher scores indicating greater depression severity. a score of 0-27 is possible. We aren't reporting subscales. A score of 5+ will screen positive for mild depression, and a score of 10+ is considered a positive to screen for moderate-severe depression. change between baseline and 6 months
Outcome measures
| Measure |
Standard of Care
n=62 Participants
The first 100 participants with HIV and depression will receive standard of care including SSRI therapy.
Depression Standard of Care: Standard clinical care for depression, which may include the use of selective serotonin re-uptake inhibitors (SSRIs).
HIV Standard of Care: Standard clinical care for HIV
|
Standard of Care + Group Support Psychotherapy
n=47 Participants
The second 100 participants with HIV and depression will receive standard of care, including SSRI therapy, and group support psychotherapy.
Group Pyschotherapy: Group psychotherapy
Depression Standard of Care: Standard clinical care for depression, which may include the use of selective serotonin re-uptake inhibitors (SSRIs).
HIV Standard of Care: Standard clinical care for HIV
|
|---|---|---|
|
Change in Patient Health Questionnaire (PHQ)-9
|
7 units on a scale
Interval 5.0 to 8.0
|
8 units on a scale
Interval 6.0 to 11.0
|
Adverse Events
Standard of Care
Standard of Care + Group Support Psychotherapy
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