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

This study is ongoing, but not recruiting participants.
Sponsor:
Collaborator:
Information provided by (Responsible Party):
Mary Kay Smith Fawzi, Harvard Medical School
ClinicalTrials.gov Identifier:
NCT02039973
First received: January 1, 2014
Last updated: August 15, 2014
Last verified: August 2014
  Purpose

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.


Condition Intervention
Depression
Behavioral: Task-sharing approach to group therapy
Behavioral: Enhanced standard of care

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Health Services Research
Official Title: Healthy Options: Group Psychotherapy for HIV-positive Depressed Perinatal Women.

Resource links provided by NLM:


Further study details as provided by Harvard Medical School:

Primary Outcome Measures:
  • Depressive disorder and suicidality [ Time Frame: Q3 2016 after an average of 1.5 years of follow-up ] [ Designated as safety issue: Yes ]
    Using a cut-off score based on the validation study, participants will be classified as having depressive and or suicidality or not. The trial aims to reduce rates of depression and suicidality among participants.


Secondary Outcome Measures:
  • Social support [ Time Frame: Q3 2016 after an average of 1.5 years of follow-up ] [ Designated as safety issue: No ]
    For this measure, the Duke University-University of North Carolina Functional Social Support Questionnaire will be used; this scale has demonstrated positive correlations with other social support scales. A listing of ten items from this of this questionnaire has been used previously in Tanzania, reflecting dimensions of instrumental and emotional support

  • Self-Efficacy [ Time Frame: Q3 2016 after an average of 1.5 years of follow-up ] [ Designated as safety issue: No ]
    The General Self-Efficacy Scale will be used to assess self-efficacy. This scale has demonstrated good internal consistency (Cronbach's alpha ranging from 0.81 to 0.91) and construct validity was shown through positive correlations with optimism and negative correlations with depression and anxiety.

  • HIV-related stigma [ Time Frame: Q3 2016 after an average of 1.5 years of follow-up ] [ Designated as safety issue: No ]
    The HIV Stigma Scale developed by Berger et al. will be used to assess stigma; it has been validated in a diverse sample in the U.S. demonstrated construct validity through factor analysis and internal consistency (Cronbach's alpha of 0.96). A sub-sample of these items also demonstrated construct validity of this scale has also been demonstrated in a resource-limited setting.

  • Intimate partner violence [ Time Frame: Q3 2016 after an average of 1.5 years of follow-up ] [ Designated as safety issue: Yes ]
    For intimate partner violence (IPV) the WHO Women's Health and Domestic Violence against Women Questionnaire will be used, which assesses emotional, sexual, and physical violence by intimate partners and has demonstrated good internal consistency ranging from 0.66 to 0.81.

  • Infant birthwight [ Time Frame: At time of birth ] [ Designated as safety issue: Yes ]
    The infant's birth weight will be measured at the time of birth.

  • Gestational Age and Prematurity [ Time Frame: At time of birth ] [ Designated as safety issue: Yes ]
    The gestational age of the infant at the time of birth will be measured. Premature infants are those whose gestational age is less than 37 weeks.

  • Infant diarrheal disease [ Time Frame: Two weeks after infant's birth ] [ Designated as safety issue: Yes ]
    The occurrence of diarrheal disease among infants will be assessed during the first two weeks of the infant's life.

  • Weight-for-height [ Time Frame: Up to 1.5 years after infant birth ] [ Designated as safety issue: Yes ]
    Wight and height will be measured as an outcome for the infant, with low weight-for-height being used to classify infants as wasting (more than two standard deviations below the mean).

  • Height-for-age [ Time Frame: Up to 1.5 years after infant's birth ] [ Designated as safety issue: Yes ]
    Height and age of infants will be measured at the end of follow-up, and low height-for-age will be used to classify infants as stunted (more than two standard deviations below the mean).


Estimated Enrollment: 720
Study Start Date: January 2014
Estimated Study Completion Date: April 2018
Estimated Primary Completion Date: February 2018 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: 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.
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.

Active Comparator: 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.
Behavioral: Enhanced standard of care
N/A

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
  Eligibility

Ages Eligible for Study:   18 Years to 49 Years
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT02039973

Locations
Tanzania
Dar es Salaam City Health Department
Dar es Salaam, Tanzania
Sponsors and Collaborators
Harvard Medical School
Investigators
Principal Investigator: Mary Kay Smith-Fawzi, ScD Harvard Medical School
Principal Investigator: Sylvia Kaaya, MD, PhD Muhimbili University of Health and Allied Sciences
  More Information

No publications provided

Responsible Party: Mary Kay Smith Fawzi, Assistant Professor of Global Health and Social Medicine, Harvard Medical School
ClinicalTrials.gov Identifier: NCT02039973     History of Changes
Other Study ID Numbers: 1R01MH100338-01, 1R01MH100338-01
Study First Received: January 1, 2014
Last Updated: August 15, 2014
Health Authority: United States: Institutional Review Board
Tanzania: National Institute for Medical Research

Keywords provided by Harvard Medical School:
HIV
AIDS
Tanzania
depression
perinatal
psychotherapy
task-sharing
problem-solving

Additional relevant MeSH terms:
Depression
Depressive Disorder
HIV Seropositivity
Behavioral Symptoms
HIV Infections
Immune System Diseases
Immunologic Deficiency Syndromes
Lentivirus Infections
Mental Disorders
Mood Disorders
RNA Virus Infections
Retroviridae Infections
Sexually Transmitted Diseases
Sexually Transmitted Diseases, Viral
Virus Diseases

ClinicalTrials.gov processed this record on November 27, 2014