Clinical trial NCT05353491: Thinking Healthy Program-Technology Assisted (THP-TA)
Official title: 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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
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
Lead sponsor: Human Development Research Foundation, Pakistan
Sponsor class: OTHER
Collaborators: name: Shifa Tameer-e-Millat University
name: University of Liverpool
First posted: 2022-04-29
Enrollment: 980
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


Eligibility criteria: Inclusion Criteria:

1. Pregnant women with current major depressive episode in their second or third trimester (4 to 8 months of pregnancy).
2. Aged 18 years and above
3. Intent to stay in the study area for at least 1 year.

Exclusion Criteria:

1. Women requiring inpatient care for any reason (medical or psychiatric) as determined by their primary health care professional
2. Those who do not comprehend Urdu language will be excluded.

Primary outcomes:
measure: Remission rates of perinatal depression
timeFrame: 3 months postnatal
Secondary outcomes:
measure: Sustained remission rates of perinatal depression
timeFrame: 3 months and 6 months postnatal
measure: Change in severity of perinatal depressive symptoms
timeFrame: 3 months and 6 months postnatal
measure: Change in severity of perinatal anxiety symptoms
timeFrame: 3 months and 6 months postnatal
measure: Change in maternal Quality of Life
timeFrame: 3 months and 6 months postnatal
measure: Change in disability using the World Health Organization Disability Assessment Schedule 2.0
timeFrame: 3 months and 6 months postnatal
measure: Service use and costs
timeFrame: Pregnancy through to 6 months postnatal
measure: Infant nutrition/breastfeeding
timeFrame: 3 months and 6 months postnatal
measure: Family planning practices
timeFrame: 3 months and 6 months postnatal
measure: Infant Immunization Status
timeFrame: 3 months and 6 months postnatal
measure: Maternal Social support
timeFrame: 3 months and 6 months postnatal
measure: Parental time spent in play with the infant
timeFrame: 3 months and 6 months postnatal
measure: Diarrheal episodes among infants
timeFrame: 3 months and 6 months postnatal
measure: Acute upper respiratory tract infections among infants
timeFrame: 3 months and 6 months postnatal
Other outcomes:
Locations:
city: Rawalpindi
country: Pakistan
facility: Human Development Research Foundation
state: Punjab
Study officials:
References:
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.