Healthy Options: Group Psychotherapy for HIV-positive Depressed Perinatal Women.
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 742
- 试验地点
- 1
- 主要终点
- Depressive disorder and suicidality
研究概览
简要总结
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.
详细描述
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:
- 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;
- Validate a depression screening tool for major depressive disorder (MDD) and suicidality for use in Tanzania; and
- 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
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Single Group
- 主要目的
- Health Services Research
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 49 Years（Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •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
排除标准
- •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
研究组 & 干预措施
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.
干预措施: Task-sharing approach to group therapy (Behavioral)
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.
干预措施: Enhanced standard of care (Behavioral)
结局指标
主要结局
Depressive disorder and suicidality
时间窗: Q3 2016 after an average of 1.5 years of follow-up
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.
次要结局
- Social support(Q3 2016 after an average of 1.5 years of follow-up)
- Self-Efficacy(Q3 2016 after an average of 1.5 years of follow-up)
- HIV-related stigma(Q3 2016 after an average of 1.5 years of follow-up)
- Intimate partner violence(Q3 2016 after an average of 1.5 years of follow-up)
- Gestational Age and Prematurity(At time of birth)
- Infant birthwight(At time of birth)
- Infant diarrheal disease(Two weeks after infant's birth)
- Weight-for-height(Up to 1.5 years after infant birth)
- Height-for-age(Up to 1.5 years after infant's birth)
研究者
Mary Kay Smith Fawzi
Assistant Professor of Global Health and Social Medicine
Harvard Medical School (HMS and HSDM)