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Thinking Healthy Program-Technology Assisted (THP-TA)

NCT05353491 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 980

Last updated 2024-11-22

No results posted yet for this study

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

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.

Sponsors & Collaborators

  • Shifa Tameer-e-Millat University

    collaborator OTHER

  • University of Liverpool

    collaborator OTHER

  • Human Development Research Foundation, Pakistan

    lead OTHER

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
FEMALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2022-06-13
Primary Completion
2024-05-01
Completion
2024-09-30

Countries

  • Pakistan

Study Locations

More Related Trials

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05353491 on ClinicalTrials.gov