Neuroinflammation and Modulating Factors in Depression and HIV

Phase 2

Completed

Interventions: Other: HIV Standard of Care
Behavioral: Group Pyschotherapy
Other: Depression Standard of Care

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.

Recruitment & Eligibility

Inclusion Criteria

For the depressed patient arm,

For the non-depressed patient arm,

Exclusion Criteria

Arm && Interventions

Group	Intervention	Description
Standard of Care (Non-Depressed)	HIV Standard of Care	100 participants with HIV and without depression will receive standard of care therapy for HIV and no depression treatment.
Standard of Care + Group Support Psychotherapy	Group Pyschotherapy	The second 100 participants with HIV and depression will receive standard of care, including SSRI therapy, and group support psychotherapy.
Standard of Care + Group Support Psychotherapy	Depression Standard of Care	The second 100 participants with HIV and depression will receive standard of care, including SSRI therapy, and group support psychotherapy.
Standard of Care + Group Support Psychotherapy	HIV Standard of Care	The second 100 participants with HIV and depression will receive standard of care, including SSRI therapy, and group support psychotherapy.
Standard of Care	Depression Standard of Care	The first 100 participants with HIV and depression will receive standard of care including SSRI therapy.
Standard of Care	HIV Standard of Care	The first 100 participants with HIV and depression will receive standard of care including SSRI therapy.

Primary Outcome Measures

Name	Time	Method
Change in Patient Health Questionnaire (PHQ)-9	Baseline, 26 weeks	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.
Change in Morning Plasma Cortisol Concentration	Baseline, 26 weeks	Plasma cortisol concentration will be measured with enzyme-linked immunosorbant assay (ELISA) and reported in ng/ml.
Change in Plasma Interleukin (IL)-6 Concentration	Baseline, 26 weeks	Plasma concentration of IL-6 will be measured using Luminex magnetic bead technology and reported in ng/ml.

Secondary Outcome Measures

Name	Time	Method

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