Neuroinflammation and Modulating Factors in Depression and HIV

Neuroinflammation and Modulating Factors in Depression and HIV: The Growth Study-Group Therapy in HIV for Depression IN Uganda

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.

Study Overview

• Status: Completed
• Conditions: Depression; HIV
• Intervention / Treatment: Other: Depression Standard of Care; Other: HIV Standard of Care; Behavioral: Group Pyschotherapy

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.

• Study Type: Interventional
• Enrollment (Actual): 109
• Phase: Phase 2

Contacts and Locations

Study Locations

• Uganda
  • Kampala, Uganda
    • Infectious Diseases Institute

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 65 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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 exclusion criteria

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Non-Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Standard of Care; The first 100 participants with HIV and depression will receive standard of care including SSRI therapy.	Other: Depression Standard of Care; Standard clinical care for depression, which may include the use of selective serotonin re-uptake inhibitors (SSRIs).; Other: HIV Standard of Care; Standard clinical care for HIV
Experimental: 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.	Other: Depression Standard of Care; Standard clinical care for depression, which may include the use of selective serotonin re-uptake inhibitors (SSRIs).; Other: HIV Standard of Care; Standard clinical care for HIV; Behavioral: Group Pyschotherapy; Group psychotherapy
Active Comparator: Standard of Care (Non-Depressed); 100 participants with HIV and without depression will receive standard of care therapy for HIV and no depression treatment.	Other: HIV Standard of Care; Standard clinical care for HIV

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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	3 months
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	6 months

Collaborators and Investigators

• Sponsor: University of Minnesota
• Collaborators: National Institute of Mental Health (NIMH)
• Investigators: Principal Investigator: Sarah Lofgren, MD, University of Minnesota

Study record dates

Study Major Dates

• Study Start (Actual): February 1, 2021
• Primary Completion (Actual): November 9, 2023
• Study Completion (Actual): April 9, 2024

Study Registration Dates

• First Submitted: February 24, 2020
• First Submitted That Met QC Criteria: February 24, 2020
• First Posted (Actual): February 26, 2020

Study Record Updates

• Last Update Posted (Actual): March 25, 2025
• Last Update Submitted That Met QC Criteria: January 4, 2025
• Last Verified: January 1, 2025

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Nervous System Diseases; Mental Disorders; Pathologic Processes; Behavioral Symptoms; Inflammation; Mood Disorders; Neuroinflammatory Diseases; Depression; Depressive Disorder
• Other Study ID Numbers: STUDY00006374; K23MH121220 (U.S. NIH Grant/Contract)

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No