Neuroinflammation and Modulating Factors in Depression and HIV

NCT ID: NCT04286282

Last Updated: 2025-01-09

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE2
• Total Enrollment: 109 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2021-02-01
• Study Completion Date: 2024-04-09

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.

Conditions

Depression; HIV

Study Design

• Allocation Method: NON_RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Standard of Care

The first 100 participants with HIV and depression will receive standard of care including SSRI therapy.

Group Type: ACTIVE_COMPARATOR

Depression Standard of Care

Intervention Type: OTHER

Standard clinical care for depression, which may include the use of selective serotonin re-uptake inhibitors (SSRIs).

HIV Standard of Care

Intervention Type: OTHER

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 Type: EXPERIMENTAL

Group Pyschotherapy

Intervention Type: BEHAVIORAL

Group psychotherapy

Depression Standard of Care

Intervention Type: OTHER

Standard clinical care for depression, which may include the use of selective serotonin re-uptake inhibitors (SSRIs).

HIV Standard of Care

Intervention Type: OTHER

Standard clinical care for HIV

Standard of Care (Non-Depressed)

100 participants with HIV and without depression will receive standard of care therapy for HIV and no depression treatment.

Group Type: ACTIVE_COMPARATOR

HIV Standard of Care

Intervention Type: OTHER

Standard clinical care for HIV

Interventions

Group Pyschotherapy

Group psychotherapy

Intervention Type: BEHAVIORAL

Depression Standard of Care

Standard clinical care for depression, which may include the use of selective serotonin re-uptake inhibitors (SSRIs).

Intervention Type: OTHER

HIV Standard of Care

Standard clinical care for HIV

Intervention Type: OTHER

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 65 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

National Institute of Mental Health (NIMH)

NIH

Sponsor Role: collaborator

University of Minnesota

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Sarah Lofgren, MD

Role: PRINCIPAL_INVESTIGATOR

University of Minnesota

Locations

Infectious Diseases Institute

Kampala, , Uganda

Countries

Uganda

Provided Documents

Document Type: Study Protocol and Statistical Analysis Plan

View Document

Document Type: Informed Consent Form

View Document

Other Identifiers

K23MH121220

Identifier Type: NIH

Identifier Source: secondary_id

View Link

STUDY00006374

Identifier Type: -

Identifier Source: org_study_id