Depression, HIV
Conditions
Brief summary
Determine if depression, which persists after depression treatment at 26 weeks, is associated with increased innate inflammation in a prospective cohort of HIV-infected Ugandans receiving SSRIs in which group psychotherapy is initiated.
Detailed description
Depression in HIV is a complex co-morbidity with both social factors such as stigma as well as biologic components. Disruptions in neurotransmitters such as serotonin and catecholamines are known to cause depression. Inflammation caused by diseases such as stroke, diabetes, and HIV is associated with higher rates of depression. HIV causes inflammation throughout the body, but since the virus can cross the blood-brain-barrier, HIV can replicate in and target the brain causing neuroinflammation which predisposes depression. However the pathophysiology of the role of inflammation in comorbid depression and HIV is poorly understood. 1. Among depressed HIV-infected Ugandans, determine if the resolution of depression at 26 weeks of HIV therapy is improved with group psychotherapy. 2. In the same population determine if persistent depression is associated with higher levels of innate inflammation. Also, compare baseline and follow up inflammation among depressed compared to non-depressed control group. 3. Evaluate if viral suppression levels at 26 weeks are improved by group psychotherapy.
Interventions
BEHAVIORALGroup Pyschotherapy
Group psychotherapy
OTHERDepression Standard of Care
Standard clinical care for depression, which may include the use of selective serotonin re-uptake inhibitors (SSRIs).
OTHERHIV Standard of Care
Standard clinical care for HIV
Sponsors
National Institute of Mental Health (NIMH)
University of Minnesota
Study design
Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 65 Years
Healthy volunteers
No
Inclusion criteria
For the depressed patient arm, * Newly-presenting clinic patients (\<3 months) * Mild to Moderately-Severe Depressive Symptoms with PHQ-9 score \>5 but \<20 * Not suicidal (PHQ-9 question 9 score \>2) * Not receiving antiretroviral therapy (ART) at screening * Outpatient, not requiring hospitalization For the non-depressed patient arm, * Newly-presenting clinic patients (\<3 months) * Not suicidal (PHQ-9 question 9 score \>2) * Not receiving antiretroviral therapy (ART) at screening * Outpatient, not requiring hospitalization
Exclusion criteria
\- No additional
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change in Patient Health Questionnaire (PHQ)-9 | 3 months | 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 |
Countries
Uganda
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| 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 | 62 |
| 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 | 47 |
| Total | 109 |
Baseline characteristics
| Characteristic | Standard of Care + Group Support Psychotherapy | Total | Standard of Care |
|---|---|---|---|
| Age, Continuous | 29 YEARS | 29 YEARS | 29 YEARS |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Asian | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Black or African American | 47 Participants | 109 Participants | 62 Participants |
| Race (NIH/OMB) More than one race | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) White | 0 Participants | 0 Participants | 0 Participants |
| Sex: Female, Male Female | 31 Participants | 74 Participants | 43 Participants |
| Sex: Female, Male Male | 16 Participants | 35 Participants | 19 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 0 | 0 / 0 |
| other Total, other adverse events | 0 / 0 | 0 / 0 |
| serious Total, serious adverse events | 0 / 0 | 0 / 0 |
Outcome results
Primary
Change in Patient Health Questionnaire (PHQ)-9
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
Time frame: 3 months
| Arm | Measure | Value (MEAN) |
|---|---|---|
| Standard of Care | Change in Patient Health Questionnaire (PHQ)-9 | 5 units on a scale |
| Standard of Care + Group Support Psychotherapy | Change in Patient Health Questionnaire (PHQ)-9 | 7 units on a scale |
Primary
Change in Patient Health Questionnaire (PHQ)-9
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 6 months
Time frame: 6 months
| Arm | Measure | Value (MEAN) |
|---|---|---|
| Standard of Care | Change in Patient Health Questionnaire (PHQ)-9 | 7 units on a scale |
| Standard of Care + Group Support Psychotherapy | Change in Patient Health Questionnaire (PHQ)-9 | 8 units on a scale |