Department of Primary Care and Mental Health, Institute of Population Health, University of Liverpool, Waterhouse Building, Block B First Floor, 1-5 Dover Street, Liverpool, L69 3GL, UK.
Health Services Academy, Islamabad, Pakistan.
Trials. 2023 Aug 25;24(1):555. doi: 10.1186/s13063-023-07581-w.
The lack of trained mental health professionals is a key barrier to scale-up of evidence-based psychological interventions in low and middle-income countries. We have developed an app that allows a peer with no prior experience of health-care delivery to deliver the cognitive therapy-based intervention for perinatal depression, the Thinking Healthy Programme (THP). This trial aims to assess the effectiveness and cost-effectiveness of this Technology-assisted peer-delivered THP versus standard face-to-face Thinking Healthy Programme delivered by trained health workers.
We will employ a non-inferiority stratified cluster randomized controlled trial design comparing the two formats of intervention delivery. A total of 980 women in the second or third trimester of pregnancy with a diagnosis of Major Depressive Episode, evaluated with the Structured Clinical Interview for DSM-V Disorders (SCID), will be recruited into the trial. The unit of randomization will be 70 village clusters randomly allocated in a 1:1 ratio to the intervention and control arms. The primary outcome is defined as remission from major depressive episode at 3 months postnatal measured with the SCID. Data will also be collected on symptoms of anxiety, disability, quality of life, service use and costs, and infant-related outcomes such as exclusive breastfeeding and immunization rates. Data will be collected on the primary outcome and selected secondary outcomes (depression and anxiety scores, exclusive breastfeeding) at 6 months postnatal to evaluate if the improvements are sustained in the longer-term. We are especially interested in sustained improvement (recovery) from major depressive episode.
This trial will evaluate the effectiveness and cost-effectiveness of a technology-assisted peer-delivered cognitive behavioral therapy-based intervention in rural Pakistan. If shown to be effective, the novel delivery format could play a role in reducing the treatment gap for perinatal depression and other common mental disorders in LMIC.
The trial was registered at Clinicaltrials.gov (NCT05353491) on 29 April 2022.
缺乏经过培训的心理健康专业人员是在中低收入国家扩大基于证据的心理干预的关键障碍。我们开发了一款应用程序，允许没有医疗保健提供经验的同行提供基于认知疗法的围产期抑郁症干预措施，即“思维健康计划”（THP）。本试验旨在评估这种由技术辅助的同伴提供的 THP 与由经过培训的卫生工作者提供的标准面对面的“思维健康计划”相比的有效性和成本效益。
我们将采用非劣效性分层集群随机对照试验设计，比较两种干预方式的效果。共有 980 名处于妊娠第二或第三个三个月且患有重性抑郁发作的女性（用 DSM-V 障碍结构临床访谈[SCID]评估）将被纳入该试验。随机分组单位为以 1:1 的比例随机分配到干预组和对照组的 70 个村庄集群。主要结局定义为产后 3 个月时用 SCID 评估的重性抑郁发作缓解。还将收集焦虑、残疾、生活质量、服务利用和成本以及与婴儿相关的结局（如纯母乳喂养和免疫接种率）的数据。将在产后 6 个月收集主要结局和选定的次要结局（抑郁和焦虑评分、纯母乳喂养）的数据，以评估在长期内是否持续改善。我们特别关注重性抑郁发作的持续改善（康复）。
本试验将评估一种技术辅助的同伴提供的基于认知行为疗法的干预措施在巴基斯坦农村地区的有效性和成本效益。如果被证明有效，这种新的提供方式可能有助于缩小中低收入国家围产期抑郁症和其他常见精神障碍的治疗差距。
该试验于 2022 年 4 月 29 日在 Clinicaltrials.gov（NCT05353491）注册。
