Technology-assisted Cognitive-behaviour Therapy Delivered by Peers Versus Standard Cognitive Behaviour Therapy Delivered by Community Health Workers for Perinatal Depression: A Cluster Randomised Controlled Non-inferiority Trial
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 980
- 试验地点
- 1
- 主要终点
- Remission rates of perinatal depression
研究概览
简要总结
Background
The Thinking Healthy Program (THP) is an evidence based task-shifted low intensity psychosocial intervention, recommended by the World Health Organization for the treatment of perinatal depression. The investigators developed a technology-assisted version of Thinking Healthy Program (THP-TA) which allows peers to deliver the THP, while ensuring minimal resources for training of delivery agents and ensuring adequate fidelity.
Method
This is a non-inferiority, pragmatic cluster randomized controlled trial designed to test the primary hypothesis that technology assisted delivery of THP is not worse than THP intervention delivered by community health workers, in increasing perinatal depression remission rates at 3 months postnatal. In addition, this study will also test the effectiveness of the THP-TA in improving recovery from perinatal depression at 6 months postpartum, quality of life and social support. This study also aims to evaluate the cost-effectiveness of the THP-TA.
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
- Double (Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Pregnant women with current major depressive episode in their second or third trimester (4 to 8 months of pregnancy).
- •Aged 18 years and above
- •Intent to stay in the study area for at least 1 year.
排除标准
- •Women requiring inpatient care for any reason (medical or psychiatric) as determined by their primary health care professional
- •Those who do not comprehend Urdu language will be excluded.
研究组 & 干预措施
Technology assisted Thinking Healthy Program delivered by peers
A technology adapted version of the Thinking Healthy Program (THP) delivered by peers using multimedia android based app. The bespoke android app leverages human-centered design and makes use of 2-d videos demonstrating narrative scripts delivered by culturally appropriate animated avatars representing depressed mothers, families, peers and mental health experts.
It is designed as a low intensity psychosocial multicomponent intervention based on cognitive behavioral approaches. The THP improves depression through psychoeducation, behavior activation, thought challenging, improving problem solving skills and by activating social support networks.
The intervention program comprises of 8 sessions delivered by trained peers.
干预措施: Technology assisted Thinking Healthy Program (THP-TA) (Behavioral)
Standard Thinking Healthy Program delivered by community health workers
The Thinking Healthy Programme (THP) is a CBT-based manualised paper version of the intervention targeting women with perinatal depression in low socioeconomic settings.
The CBT techniques include guided discovery using illustrated brief vignettes, behavioural activation, and problem solving. Non-specific techniques include empathic listening and promoting social support from key family members for the mother in negotiating challenges during the perinatal period. This intervention programme is paper based utilizing reference manual, health calendar and job aid as tools for delivering content.
The intervention employs these techniques to improve outcomes in three areas: maternal well-being, mother-infant interaction and relationship with significant others. The intervention consists of 8 core sessions starting in the second or third trimester of pregnancy and continuing to 3 months postnatal.
干预措施: Standard Thinking Healthy Program (Behavioral)
结局指标
主要结局
Remission rates of perinatal depression
时间窗: 3 months postnatal
Remission rates from perinatal depression among the trial participants will be based on clinical diagnostic criteria based on the Structured Clinical Interview for the DSM-IV Axis (SCID) module. The SCID will be employed at baseline and 3 months postnatal.
次要结局
- Sustained remission rates of perinatal depression(3 months and 6 months postnatal)
- Change in disability using the World Health Organization Disability Assessment Schedule 2.0(3 months and 6 months postnatal)
- Infant nutrition/breastfeeding(3 months and 6 months postnatal)
- Family planning practices(3 months and 6 months postnatal)
- Maternal Social support(3 months and 6 months postnatal)
- Parental time spent in play with the infant(3 months and 6 months postnatal)
- Change in maternal Quality of Life(3 months and 6 months postnatal)
- Acute upper respiratory tract infections among infants(3 months and 6 months postnatal)
- Change in severity of perinatal depressive symptoms(3 months and 6 months postnatal)
- Service use and costs(Pregnancy through to 6 months postnatal)
- Change in severity of perinatal anxiety symptoms(3 months and 6 months postnatal)
- Infant Immunization Status(3 months and 6 months postnatal)
- Diarrheal episodes among infants(3 months and 6 months postnatal)
研究者
Siham Sikander
Co-investigator
University of Liverpool