Feasibility, Acceptability, Appropriateness, and Preliminary Effectiveness of "Thinking Healthy Programme" for Perinatal Depression in Nepal: A Pilot Cluster Randomized Controlled Trial
试验速览
- 阶段
- 不适用
- 发起方
- 入组人数
- 120
- 试验地点
- 2
- 主要终点
- Change in Female Community Health Volunteers' clinical skills to provide psychological support
研究概览
简要总结
As many as 1 in 3 women in Nepal suffer from perinatal depression however, they often go unidentified and untreated. Lack of knowledge limited trained human resources, and unavailability of specific maternal mental health services are some of the major barriers impeding help-seeking. To mitigate this gap, the World Health Organization recommended Thinking Healthy Programme (THP), a psychological intervention that can be delivered by non-specialists and has been proven effective for perinatal depression in a resource constrained context. The THP has already been translated and adapted to Nepali context. In this study, the investigators plan to pilot test the intervention and assess its feasibility, acceptability, appropriateness, and preliminary effectiveness when delivered by the Female Community Health Volunteers (FCHVs). The FCHVs are cadre of Nepal Government mobilized for the prevention and promotion of maternal and child health in the community level.
详细描述
The Thinking Healthy Programme (THP) is a community based low-intensity psychosocial intervention tailored for perinatal depression in improving outcomes in three areas - a) mother's health, b) the mother-baby relationship, and c) the mother's relationship with others. The intervention has already been tested in other South Asian context and has been found effective in reducing depressive symptoms and promoting wellbeing even when delivered by a non-specialist with limited education. The intervention is basic and does not require prior knowledge or experience on mental health however, it is preferred that the deliverer should at least know about basics of maternal and childcare. In a resource poor country like Nepal where the investment and human resource for maternal mental health is scanty despite the high burden, the THP can be promising given its effectiveness and cost-effectiveness. The THP has already been adapted to the Nepali context.
For the pilot-testing of THP, 4 health facilities will be selected. The health facilities will be randomized to intervention and control arm (2 health facilities in each arm). A list of pregnant women from the health facility's and FCHV's catchment area will be collected from the health facility's outpatient department (OPD) register and FCHV's register/logbook. Eligible women will be screened by the research assistant using the Patient Health Questionnaire (PHQ-9), a screening tool for depression consisting of 9 questions that has already been validated in Nepal. If the woman scores 10 or above in the screening tool, the research assistant will collect the baseline information within 1 week and will refer the woman to the respective FCHV from the same locality as the woman's. The FCHVs in the intervention arm will meet the woman, administer consent form regarding the "Thinking Healthy Programme" (THP). Participants providing consent will be engaged in the THP programme that will be delivered by the trained FCHV. The FCHVs in the control arm will meet the woman, provide psychoeducation, and refer to the health facility where mental health services are available.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 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
- 是
入选标准
- •Pregnant women
- •Should be residing in the FCHV's catchment area
- •Should be between 4-7 months pregnant.
- •Should have no severe physical health conditions
- •Should have depressive symptoms (scores 10 or higher in PHQ-9).
排除标准
- •Women reporting miscarriage, abortion, or still birth will be excluded from the THP intervention (but referred to the psychosocial counsellor for further care)
结局指标
主要结局
Change in Female Community Health Volunteers' clinical skills to provide psychological support
时间窗: From pre training to immediate post training
Competency of Female Community Health Volunteers will be assessed through Ensuring Quality in Psychological Support (EQUIP), an online platform consisting of a tool to assess clinical competency of mental health and psychosocial service providers. A service providers' competency is assessed in a Likert scale where 1 represents having harmful behaviour, 2 represents having any or none of the basic helping skills, 3 represents having all basic skills and 4 represents having any advanced skills.
Qualitative Information: Feasibility from service providers' perspective
时间窗: Month 18
Service providers who deliver the Thinking Healthy Programme for duration of project will be asked through Focus Group Discussion and Key Informant Interviews about the feasibility of recruiting women with perinatal depression, delivering intervention in the community setting, engaging women, and their family members in the session.
Qualitative Information: Acceptability from service providers' perspective
时间窗: Month 18
Service providers who deliver the Thinking Healthy Programme for duration of project will be asked through Focus Group Discussion and Key Informant Interviews about their experience delivering intervention focusing on facilitators and barriers, perceived benefits and challenges of intervention for perinatal depression, and their willingness to engage as deliver agents in the future.
Qualitative Information: Appropriateness of Thinking Healthy Programme from service users' perspective
时间窗: 3 months postnatal
Women with perinatal depression and their family members engaged in the Thinking Healthy Programme will be interviewed to explore their perception towards the intervention, its utility, suitability for their problem.
Qualitative Information: Feasibility from service users' perspective
时间窗: 3 months postnatal
Women with perinatal depression and their family members engaged in the Thinking Healthy Programme will be interviewed to explore feasibility in terms of engaging in the session, scheduling time for session, and completing tasks.
Qualitative Information: Acceptability of of Thinking Healthy Programme from service users' perspective
时间窗: 3 months postnatal
Women with perinatal depression and their family members engaged in the Thinking Healthy Programme will be interviewed to explore facilitators and barriers to engage in the session, perceived benefits and challenges of receiving intervention in the home setting, and their perception of the service provider.
Qualitative Information: Appropriateness of Thinking Healthy Programme from service providers' perspective
时间窗: Month 18
Service providers who deliver the Thinking Healthy Programme for duration of project will be asked through Focus Group Discussion and Key Informant Interviews about their perception towards the intervention, its utility, suitability in Nepali context.
次要结局
- Changes in Multidimensional Scale of Perceived Social Support(Baseline (M0), 2 months after baseline (M2), 3 months postnatal (M4-M8))
- Postnatal care attendance(3 months postnatal (M4-M8))
- Suicide Assessment(Baseline (M0), 2 months after baseline (M2), 3 months postnatal (M4-M8))
- Domestic violence(Baseline (M0), 2 months after baseline (M2), 3 months postnatal (M4-M8))
- Antenatal care attendance(Baseline (M0), 2 months after baseline (M2))
- Changes in World Health Organization's Disability Assessment Schedule(Baseline (M0), 2 months after baseline (M2), 3 months postnatal (M4-M8))
- Changes in Alcohol Use Disorder Identification Test(Baseline (M0), 2 months after baseline (M2), 3 months postnatal (M4-M8))
- Changes in Internalized Stigma of Mental Illness(Baseline (M0), 2 months after baseline (M2), 3 months postnatal (M4-M8))
- Changes in Patient Health Questionnaire-9+1(Baseline (M0), 2 months after baseline (M2), 3 months postnatal (M4-M8))
- Changes in Generalized Anxiety Disorder Scale(Baseline (M0), 2 months after baseline (M2), 3 months postnatal (M4-M8))
- Exclusive breastfeeding(3 months postnatal (M4-M8))