NCT05353491

Thinking Healthy Program-Technology Assisted (THP-TA)

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

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 980 (actual)
• Sponsor: Human Development Research Foundation, Pakistan · Academic / Other
• Sex: Female
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

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.

Conditions

• Perinatal Depression
• Depression, Postpartum

Interventions

Type	Name	Description
BEHAVIORAL	Technology assisted Thinking Healthy Program (THP-TA)	A technology adapted version of the Thinking Healthy Program (THP) delivered by peers using multimedia android based app.
BEHAVIORAL	Standard Thinking Healthy Program	This intervention paper-based manual delivered by lady health workers ie government employed community health workers with health training background.

Timeline

• Start date: 2022-06-13
• Primary completion: 2024-05-01
• Completion: 2024-09-30
• First posted: 2022-04-29
• Last updated: 2024-11-22

Locations

1 site across 1 country: Pakistan