Technology-assisted cognitive-behavior therapy delivered by peers versus standard cognitive behavior therapy delivered by community health workers for perinatal depression: study protocol of a cluster randomized controlled non-inferiority trial

Trials

Study Protocol

Ahmed Waqas¹  Siham Sikander¹  Atif Rahman¹  Abid Malik²  Najia Atif³  Ahmed Zaidi³  Huma Nazir³  Maria Sharif³  Anum Nisar³  Duolao Wang⁴  Tao Chen⁵ 

[1] Department of Primary Care and Mental Health, Institute of Population Health, University of Liverpool, Waterhouse Building, Block B First Floor, 1-5 Dover Street, L69 3GL, Liverpool, UK;Health Services Academy, Islamabad, Pakistan;Human Development Research Foundation, Islamabad, Pakistan;Liverpool School of Tropical Medicine, Liverpool, UK;University of York, York, UK;

关键词: Perinatal depression;    Psychosocial intervention;    Cognitive-behavioral therapy;    Thinking Healthy Programme;    Digital intervention;    Technology;    Mental health;   

DOI  :  10.1186/s13063-023-07581-w

 received in 2023-06-10, accepted in 2023-08-11,  发布年份 2023

来源: Springer

【 摘 要 】

BackgroundThe 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.MethodsWe 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.DiscussionThis 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.Trial registrationThe trial was registered at Clinicaltrials.gov (NCT05353491) on 29 April 2022.

【 授权许可】

CC BY   
© BioMed Central Ltd., part of Springer Nature 2023

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Fig. 3