Thinking Healthy Program-Technology Assisted (THP-TA)

Study Overview
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Brief Summary
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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.

Official Title
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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

Conditions
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Perinatal Depression, Depression, Postpartum

Intervention / Treatment
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* Behavioral: Technology assisted Thinking Healthy Program (THP-TA)
* Behavioral: Standard Thinking Healthy Program


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: 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. Exclusion Criteria: 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.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Technology assisted Thinking Healthy Program delivered by peers<br>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)<br>* A technology adapted version of the Thinking Healthy Program (THP) delivered by peers using multimedia android based app.<br>|
| Active Comparator: Standard Thinking Healthy Program delivered by community health workers<br>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<br>* This intervention paper-based manual delivered by lady health workers ie government employed community health workers with health training background.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Sustained remission rates of perinatal depression | Sustained 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, assessed at baseline, 3 and 6 months postnatal. | 3 months and 6 months postnatal | 
| Change in severity of perinatal depressive symptoms | Severity of perinatal depressive symptoms will be measured using the Patient Health Questionnaire-9 items assessed at baseline, 3 months and 6 months postnatal. Score on this scale ranges from 0 to 27, with higher scores indicating increased severity. | 3 months and 6 months postnatal | 
| Change in severity of perinatal anxiety symptoms | Severity of perinatal anxiety symptoms will be measured using the Generalized anxiety Disorder-7 scale assessed at baseline, 3 months and 6 months postnatal. Score on this scale ranges from 0 to 21, with higher scores indicating increased severity. | 3 months and 6 months postnatal | 
| Change in maternal Quality of Life | Change in maternal quality of life will be measured using the EuroQuality of Life scale (EQ-5D-3L), at baseline, 3 months and 6 months postnatal. It is a valid and reliable scale to quantify health status across 5 dimensions: mobility, self-care, usual activities, pain/discomfort and anxiety/depression. | 3 months and 6 months postnatal | 
| Change in disability using the World Health Organization Disability Assessment Schedule 2.0 | This World Health Organization Disability Assessment Schedule 2.0 questionnaire assesses disability due to health conditions or illnesses (chronic or acute) including mental and emotional health problems. It is a valid and reliable instrument that generates domain-specific scores for six different functioning domains: i) cognition ii) mobility iii) self-care iv) getting along v) life activities (household and work/school) and vi) participation. It will be employed at baseline, 3 and 6 months postnatal. | 3 months and 6 months postnatal | 
| Service use and costs | Service use will be measured using Client Service Receipt Inventory (CSRI), including costs of healthcare services used, details and costs of medications and wider health service utilization and economic costs at 3 months and 6 months postnatal. | Pregnancy through to 6 months postnatal | 
| Infant nutrition/breastfeeding | Using 24-hour recall WHO breastfeeding practices tool, we will quantify percentage of infants being exclusively breastfed at 3 months and 6 months postnatal. | 3 months and 6 months postnatal | 
| Family planning practices | To ascertain family planning practices, categorical questions will be asked regarding the use of contraception during the postpartum period. | 3 months and 6 months postnatal | 
| Infant Immunization Status | Immunization status of the infant will be assessed using a categorical question assessing completely or incompletely immunized as per the Expanded Programme on Immunization program in Pakistan, at 3 months and 6 months postnatal. | 3 months and 6 months postnatal | 
| Maternal Social support | Multidimensional Scale of Perceived Social Support (MSPSS) will be used to assess the perceived levels of social support among the intervention recipients at baseline, 3 months and 6 months postnatal, from three sources: family, friends and significant other. It comprises of 12 items, scores on which can be summed together with higher scores corresponding to better social support. | 3 months and 6 months postnatal | 
| Parental time spent in play with the infant | Parental time spent in play with the infant will be assessed at 3 months and 6 months postnatal. | 3 months and 6 months postnatal | 
| Diarrheal episodes among infants | Number of episodes of diarrheal episodes among infants will be assessed using the WHO criteria and definitions, at 3 months and 6 months postnatal | 3 months and 6 months postnatal | 
| Acute upper respiratory tract infections among infants | Number of episodes of acute upper respiratory tract infections among infants will be assessed using the WHO criteria and definitions, at 3 months and 6 months postnatal | 3 months and 6 months postnatal | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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CBT, Perinatal depression, Perinatal anxiety, perinatal mental health conditions, electronic CBT, task shifting, low-resourced settings, task sharing, Thinking Healthy Programme, LMIC, Technology-assisted, peers, community health workers