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

NCT ID: NCT02039973

Last Updated: 2018-02-22

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 742 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2013-07-01
• Study Completion Date: 2017-12-31

Brief 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

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: HEALTH_SERVICES_RESEARCH
• Blinding Strategy: NONE

Study Groups

Task-sharing approach to group therapy

The intervention will consist of problem-solving therapy as well as cognitive behavioral components. Core problem-solving therapy components will involve lay CBHW facilitated discussions to explore symptoms of depression and how problems are related to depression. Core cognitive behavioral components will include lay CBHW facilitated discussions to explain the purpose of the sessions, as well as effect a number of behavioral changes in participants.

Group Type: EXPERIMENTAL

Task-sharing approach to group therapy

Intervention Type: BEHAVIORAL

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.

Enhanced standard of care

The control condition will promote an enhanced standard of care. Clinicians and nurses at MCH clinics included in the study will receive a structured one day re-orientation training consistent with the World Health Organization (WHO) mh-GAP guidelines for assessment as well as basic psychosocial and drug treatment of moderate to severe depression in primary care settings. The training will be consistent with the standard of care for mental health among HIV-positive populations as outlined in Tanzanian health policy. In addition, clinical staff will be trained to encourage women to invite their male partners to accompany them at clinic visits, where psycho-education on perinatal depression for couples will be offered for those opting to participate.

Group Type: ACTIVE_COMPARATOR

Enhanced standard of care

Intervention Type: BEHAVIORAL

Interventions

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.

Intervention Type: BEHAVIORAL

Enhanced standard of care

Intervention Type: BEHAVIORAL

Eligibility Criteria

Inclusion Criteria

• pregnant women who access PMTCT-plus services at MCH clinics in Dar es Salaam
• HIV-positive serostatus
• screen positive for depression
• less than 28 weeks of gestation
• confirm they will attend postnatal services at the maternal and child health service they enrolled in for antenatal care for at least two years after they give birth

Exclusion Criteria

• any woman less than 18 years of age
• HIV-negative
• screened negative for depression
• screened positive for depression and assessed to be of high suicide risk requiring immediate emergency referral for care
• not able to continue to receive care at the MCH clinic where they were initially enrolled for at least two years after giving birth

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 49 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: No

Sponsors

National Institute of Mental Health (NIMH)

NIH

Sponsor Role: collaborator

Harvard Medical School (HMS and HSDM)

OTHER

Sponsor Role: lead

Responsible Party

Mary Kay Smith Fawzi

Assistant Professor of Global Health and Social Medicine

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Mary Kay Smith-Fawzi, ScD

Role: PRINCIPAL_INVESTIGATOR

Harvard Medical School (HMS and HSDM)

Sylvia Kaaya, MD, PhD

Role: PRINCIPAL_INVESTIGATOR

Muhimbili University of Health and Allied Sciences

Locations

Dar es Salaam City Health Department

Dar es Salaam, , Tanzania

Countries

Tanzania

References

Kaaya S, Siril H, Fawzi MCS, Aloyce Z, Araya R, Kaale A, Kasmani MN, Komba A, Minja A, Mwimba A, Ngakongwa F, Somba M, Sudfeld CR, Larson E. A peer-facilitated psychological group intervention for perinatal women living with HIV and depression in Tanzania-Healthy Options: A cluster-randomized controlled trial. PLoS Med. 2022 Dec 13;19(12):e1004112. doi: 10.1371/journal.pmed.1004112. eCollection 2022 Dec.

Reference Type: DERIVED

PMID: 36512631 (View on PubMed)

Smith Fawzi MC, Siril H, Larson E, Aloyce Z, Araya R, Kaale A, Kamala J, Kasmani MN, Komba A, Minja A, Mwimba A, Ngakongwa F, Somba M, Sudfeld CR, Kaaya SF. Healthy Options: study protocol and baseline characteristics for a cluster randomized controlled trial of group psychotherapy for perinatal women living with HIV and depression in Tanzania. BMC Public Health. 2020 Jan 20;20(1):80. doi: 10.1186/s12889-019-7907-6.

Reference Type: DERIVED

PMID: 31959151 (View on PubMed)

Other Identifiers

1R01MH100338-01

Identifier Type: NIH

Identifier Source: secondary_id

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1R01MH100338-01

Identifier Type: NIH

Identifier Source: org_study_id

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