Thinking Healthy Program-Technology Assisted (THP-TA)

NCT05353491 | Completed DMC

• 2 other identifiers: UoL001668NIHR200817
• Study Type: interventional
• Target: 980
• Locations: 1 country
• Sites: 1

Brief 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

Keywords

Perinatal depression; Perinatal anxiety; perinatal mental health conditions; electronic CBT; CBT; task shifting; low-resourced settings; task sharing; Thinking Healthy Programme; LMIC; Technology-assisted; peers; community health workers

Outcome Measures

Primary Outcomes (1)

• Remission rates of perinatal depression

  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.

  3 months postnatal

Secondary Outcomes (13)

• Sustained remission rates of perinatal depression

  3 months and 6 months postnatal

• Change in severity of perinatal depressive symptoms

  3 months and 6 months postnatal

• Change in severity of perinatal anxiety symptoms

  3 months and 6 months postnatal

• Change in maternal Quality of Life

  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

Study Arms (2)

Technology assisted Thinking Healthy Program delivered by peers

EXPERIMENTAL

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.

Behavioral: Technology assisted Thinking Healthy Program (THP-TA)

Standard Thinking Healthy Program delivered by community health workers

ACTIVE COMPARATOR

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.

Behavioral: Standard Thinking Healthy Program

Interventions

Technology assisted Thinking Healthy Program (THP-TA) BEHAVIORAL

A technology adapted version of the Thinking Healthy Program (THP) delivered by peers using multimedia android based app.

Technology assisted Thinking Healthy Program delivered by peers

Standard Thinking Healthy Program BEHAVIORAL

This intervention paper-based manual delivered by lady health workers ie government employed community health workers with health training background.

Standard Thinking Healthy Program delivered by community health workers

Eligibility Criteria

• Age: 18 Years+
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Human Development Research Foundation, Pakistan: lead
• Shifa Tameer-e-Millat University: collaborator
• University of Liverpool: collaborator

Study Sites (1)

Human Development Research Foundation

Rawalpindi, Punjab Province, Pakistan

Location

Related Publications (8)

• Rahman A, Malik A, Sikander S, Roberts C, Creed F. Cognitive behaviour therapy-based intervention by community health workers for mothers with depression and their infants in rural Pakistan: a cluster-randomised controlled trial. Lancet. 2008 Sep 13;372(9642):902-9. doi: 10.1016/S0140-6736(08)61400-2.

  PMID: 18790313 BACKGROUND

• Sikander S, Ahmad I, Atif N, Zaidi A, Vanobberghen F, Weiss HA, Nisar A, Tabana H, Ain QU, Bibi A, Bilal S, Bibi T, Liaqat R, Sharif M, Zulfiqar S, Fuhr DC, Price LN, Patel V, Rahman A. Delivering the Thinking Healthy Programme for perinatal depression through volunteer peers: a cluster randomised controlled trial in Pakistan. Lancet Psychiatry. 2019 Feb;6(2):128-139. doi: 10.1016/S2215-0366(18)30467-X.

  PMID: 30686386 BACKGROUND

• Fuhr DC, Weobong B, Lazarus A, Vanobberghen F, Weiss HA, Singla DR, Tabana H, Afonso E, De Sa A, D'Souza E, Joshi A, Korgaonkar P, Krishna R, Price LN, Rahman A, Patel V. Delivering the Thinking Healthy Programme for perinatal depression through peers: an individually randomised controlled trial in India. Lancet Psychiatry. 2019 Feb;6(2):115-127. doi: 10.1016/S2215-0366(18)30466-8.

  PMID: 30686385 BACKGROUND

• Rahman A, Akhtar P, Hamdani SU, Atif N, Nazir H, Uddin I, Nisar A, Huma Z, Maselko J, Sikander S, Zafar S. Using technology to scale-up training and supervision of community health workers in the psychosocial management of perinatal depression: a non-inferiority, randomized controlled trial. Glob Ment Health (Camb). 2019 May 16;6:e8. doi: 10.1017/gmh.2019.7. eCollection 2019.

  PMID: 31157115 BACKGROUND

• Maselko J, Sikander S, Turner EL, Bates LM, Ahmad I, Atif N, Baranov V, Bhalotra S, Bibi A, Bibi T, Bilal S, Biroli P, Chung E, Gallis JA, Hagaman A, Jamil A, LeMasters K, O'Donnell K, Scherer E, Sharif M, Waqas A, Zaidi A, Zulfiqar S, Rahman A. Effectiveness of a peer-delivered, psychosocial intervention on maternal depression and child development at 3 years postnatal: a cluster randomised trial in Pakistan. Lancet Psychiatry. 2020 Sep;7(9):775-787. doi: 10.1016/S2215-0366(20)30258-3.

  PMID: 32828167 BACKGROUND

• Vanobberghen F, Weiss HA, Fuhr DC, Sikander S, Afonso E, Ahmad I, Atif N, Bibi A, Bibi T, Bilal S, De Sa A, D'Souza E, Joshi A, Korgaonkar P, Krishna R, Lazarus A, Liaqat R, Sharif M, Weobong B, Zaidi A, Zuliqar S, Patel V, Rahman A. Effectiveness of the Thinking Healthy Programme for perinatal depression delivered through peers: Pooled analysis of two randomized controlled trials in India and Pakistan. J Affect Disord. 2020 Mar 15;265:660-668. doi: 10.1016/j.jad.2019.11.110. Epub 2019 Nov 23.

  PMID: 32090783 BACKGROUND

• Rahman A, Malik A, Nazir H, Zaidi A, Nisar A, Waqas A, Atif N, Gibbs NK, Luo Y, Sikander S, Wang D. Technology-assisted cognitive-behavioral therapy for perinatal depression delivered by lived-experience peers: a cluster-randomized noninferiority trial. Nat Med. 2025 Jul;31(7):2196-2203. doi: 10.1038/s41591-025-03655-1. Epub 2025 Apr 8.

  PMID: 40200057 DERIVED

• Rahman A, Malik A, Atif N, Nazir H, Zaidi A, Nisar A, Waqas A, Sharif M, Chen T, Wang D, Sikander S. 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. 2023 Aug 25;24(1):555. doi: 10.1186/s13063-023-07581-w.

  PMID: 37626428 DERIVED

MeSH Terms

Conditions

Depression, Postpartum

Condition Hierarchy (Ancestors)

Puerperal Disorders; Pregnancy Complications; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Depressive Disorder; Mood Disorders; Mental Disorders

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Co-investigator

Study Record Dates

• First Submitted: March 28, 2022
• First Posted: April 29, 2022
• Study Start: June 13, 2022
• Primary Completion: May 1, 2024
• Study Completion: September 30, 2024
• Last Updated: November 22, 2024

Record last verified: 2024-11

Data Sharing

• IPD Sharing: Will not share

Locations

PA (1)