Thinking Healthy Program-Technology Assisted (THP-TA)

Human Development Research Foundation, Pakistan

Status: Completed

Conditions: Perinatal Depression; Depression, Postpartum

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

Study type: Interventional

Funder types: Other

Identifiers

NCT05353491

NIHR200817 (Other Grant/Funding Number)

UoL001668

Details and patient eligibility

About

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.

Enrollment: 980 patients

Sex: Female

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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980 participants in 2 patient groups

Technology assisted Thinking Healthy Program delivered by peers

Experimental group

Description:

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.

Treatment:

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

Standard Thinking Healthy Program delivered by community health workers

Active Comparator group

Description:

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.

Treatment:

Behavioral: Standard Thinking Healthy Program