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Completed

NCT Number: NCT05353491

Thinking Healthy Program-Technology Assisted (THP-TA)

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.

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Key information

Age range

18 year and older

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

Human Development Research Foundation

Rawalpindi, Punjab Province, Pakistan

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

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.

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.

Primary outcomes

  1. Remission rates of perinatal depression

    Time frame: 3 months postnatal

    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.

Secondary outcomes

  1. Sustained remission rates of perinatal depression

    Time frame: 3 months and 6 months postnatal

    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.

  2. Change in severity of perinatal depressive symptoms

    Time frame: 3 months and 6 months postnatal

    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. Change in severity of perinatal anxiety symptoms

    Time frame: 3 months and 6 months postnatal

    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.

  4. Change in maternal Quality of Life

    Time frame: 3 months and 6 months postnatal

    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.

  5. Change in disability using the World Health Organization Disability Assessment Schedule 2.0

    Time frame: 3 months and 6 months postnatal

    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.

  6. Service use and costs

    Time frame: Pregnancy through to 6 months postnatal

    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.

  7. Infant nutrition/breastfeeding

    Time frame: 3 months and 6 months postnatal

    Using 24-hour recall WHO breastfeeding practices tool, we will quantify percentage of infants being exclusively breastfed at 3 months and 6 months postnatal.

  8. Family planning practices

    Time frame: 3 months and 6 months postnatal

    To ascertain family planning practices, categorical questions will be asked regarding the use of contraception during the postpartum period.

  9. Infant Immunization Status

    Time frame: 3 months and 6 months postnatal

    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.

  10. Maternal Social support

    Time frame: 3 months and 6 months postnatal

    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.

  11. Parental time spent in play with the infant

    Time frame: 3 months and 6 months postnatal

    Parental time spent in play with the infant will be assessed at 3 months and 6 months postnatal.

  12. Diarrheal episodes among infants

    Time frame: 3 months and 6 months postnatal

    Number of episodes of diarrheal episodes among infants will be assessed using the WHO criteria and definitions, at 3 months and 6 months postnatal

  13. Acute upper respiratory tract infections among infants

    Time frame: 3 months and 6 months postnatal

    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

Sponsors and collaborators

Lead sponsor

Human Development Research Foundation, Pakistan

Other

Collaborators

  • Shifa Tameer-e-Millat University
  • University of Liverpool

Registry information

Official study 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

Acronym: THP-TA

Important dates

Study start
2022
Primary completion
2024
Study completion
2024
First posted
Apr 29, 2022
Registry last updated
Nov 22, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

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This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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