NCT02039973

Healthy Options: Group Psychotherapy for HIV-positive Depressed Perinatal Women.

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 742 (actual)
• Sponsor: Harvard Medical School (HMS and HSDM) · Academic / Other
• Sex: Female
• Age: 18 Years – 49 Years
• Healthy volunteers: Not accepted

Summary

Although there is a significant burden of depression among HIV-positive women in Tanzania, there is a critical gap between the needs of this population and the integration of mental health and PMTCT-plus services. The long-term intent of the research is to bridge this gap with the overall goal to examine the potential for successful integration of enhanced mental health care and brief group interventions among HIV-positive women receiving PMTCT-plus services and to evaluate a combination of evidence-based approaches for treatment of depression in this vulnerable population in Tanzania.

Detailed description

In resource-limited settings, there has been a significant increase in access to antiretroviral therapy (ART) in recent years. Although there remain serious limitations in access to ART in these settings, for many who have initiated and continue treatment, HIV disease is a chronic condition that needs to be managed over time. There is considerable evidence that individuals with chronic illness have an increased risk of depression, in part related to the challenges in coping and managing their illness. Rates for depression during pregnancy in women living with HIV are estimated to be higher. Despite this relatively high burden of depression among persons living with HIV/AIDS (PLHA), it has been documented that clinical staff working with PLHA do not routinely identify or treat depression in this setting. This is in contrast to recent revisions in the Tanzanian health policy that emphasize integrating mental health and HIV care at district and lower level health care services. The long-term intent of the research is to bridge this gap between Tanzanian health policy and implementation of integrating mental health care among pre- and post-natal women receiving HIV care. Therefore, the overall goal of the proposed study is to examine the potential for successful integration of enhanced mental health care and group counseling among HIV-positive women receiving preventing mother to child transmission (PMTCT)-plus services and to evaluate a combination of evidence-based approaches in treatment of depression in this vulnerable population in Tanzania. Specifically this application aims to: 1. Examine the acceptability and feasibility of integrating an enhanced standard of mental health care and group counseling with PMTCT-plus services provided at government-run maternal and child health (MCH) clinics, from the perspectives of: a) facility mental health care focal points and MCH clinic managers, b) perinatal direct care providers; and c) HIV-positive perinatal women; 2. Validate a depression screening tool for major depressive disorder (MDD) and suicidality for use in Tanzania; and 3. Conduct a cluster randomized controlled trial comparing a task-sharing approach (i.e. problem solving and cognitive behavioral therapy components delivered to groups facilitated by lay community based health care workers (CBHWs) versus improved standard

Conditions

• Depression

Interventions

Type	Name	Description
BEHAVIORAL	Task-sharing approach to group therapy	Participants will also identify, select and clarify common concerns/problems; provide orientation to steps in problem-solving; break down identified problems into manageable pieces; choose pieces of problem to address in facilitated discussion of problem solving for implementing solutions; support the sharing of feedback of strategies used in problem-solving and maintaining pleasurable activities. Additionally, the intervention to aim to effect behavior by: explaining the links between problems, negative thoughts, choices made on a day-to-day basis, behaviors, and mood (symptoms of depression); facilitate sharing of practical skills to tackle problems, to change mood-related thoughts, choices and/or behaviors; offer and provide feedback on homework assignments to encourage practice of skills; and help participants attribute reported improvements to the use of new skills during feedback sessions.
BEHAVIORAL	Enhanced standard of care

Timeline

• Start date: 2013-07-01
• Primary completion: 2017-12-31
• Completion: 2017-12-31
• First posted: 2014-01-20
• Last updated: 2018-02-22

Locations

1 site across 1 country: Tanzania