Thinking Healthy Program - Peer Delivered (Pakistan) (THPP-P)

December 20, 2019 updated by: Atif Rahman, University of Liverpool

Thinking Healthy Program - Peer Delivered in Pakistan

The rates of perinatal depression in South Asian women are reported to be amongst the highest in the world, ranging from 18%-30% in urban areas and 28%-36% in rural areas. In addition to its profound impact on women's health, disability and functioning, perinatal depression is associated with poor child health outcomes such as pre-term birth, infant under-nutrition and stunting. There is robust evidence that perinatal depression can be effectively managed with psychological treatments delivered by non-specialist health care workers. Our previous research conducted in Pakistan led to the development of the Thinking Healthy Program (THP). THP is a psychological treatment delivered by community health workers (CHWs) which more than halved the rate of perinatal depression among mothers and led to significant improvements in child health outcomes. To enhance access to such evidence-based psychological treatments, there is a need to examine the potential role of other human resources such as lay persons in delivering psychological treatments such as THP in poor resource settings.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

Objectives To evaluate the effectiveness and cost-effectiveness of THP delivered by peers (the Thinking Healthy Program - Peer delivered in Rawalpindi, Pakistan; THPP-P) over the duration of 6 months. Peers will be healthy mothers who live in the same community as potential trial participants (TPs).

Study design and outcomes Single-blind stratified cluster randomized controlled trial in Rawalpindi, Pakistan (rural area) involving 40 clusters (560 women). TPs will not be blinded to treatment allocation. TPs include all pregnant women in their third trimester of pregnancy who are identified through the list of their local community health worker (Lady Health Worker or LHW). Those who are eligible will be invited to participate in screening for depression; mothers who consent will be screened for depression with a locally validated version of the Patient Health Questionnaire (PHQ-9). TPs who screen positive (PHQ-9 score ≥ 10) receive enhanced usual care (EUC) or THPP+EUC. The primary outcome measures will be remission (i.e. recovery from depression) and reduction in depressive symptoms, both assessed by the PHQ-9 at 6 months post child birth. Secondary outcomes are depressive symptoms and remission at 3 months (PHQ-9), maternal disability at 3 and 6 months post child birth (measured with the WHO-DAS), improved maternal support (measured with MSPSS) at 3 and 6 months post child birth, breastfeeding rates and infant weight and height of children at 3 and 6 months. Outcomes will be analysed on an intention to treat basis.

Interventions EUC will comprise communicating the results to the mother's LHW and medical officer (MO) at the Basic Health Unit (BHU) of her area, providing the MO with the WHO mhGAP guidelines for the treatment of depression, and providing guidance on referral of depressed mothers to mental health services. TPs who are in the THPP group will receive, in addition, 14 sessions of THPP starting from their recruitment in the third trimester until up to 5 months after child birth. Sessions will be delivered by peers on an individual and group basis at a location of convenience to the TPs (usually at their own homes).

Implications THPP has the potential to advance knowledge of the extent to which task-shifting of the delivery of evidence-based psychological treatments can be extended to peers in the community. If effectiveness is observed, this approach offers a potential opportunity to access a vast untapped human resource for maternal mental health care and addresses a major barrier in global mental health - the lack of skilled and motivated human resources in the formal health sector - offering a new avenue for the scaling up of evidence-based psychological treatments in low resourced settings.

Study Type

Interventional

Enrollment (Actual)

560

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Pakistan
      • Islamabad, Pakistan
        • Human Development Research Foundation

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Female

Description

Inclusion Criteria:

  • Depressive disorder (PHQ-9 (>10 score)),
  • In the 3rd trimester of pregnancy,
  • Aged 18 years and over,
  • Intending to reside in the study area for the entire duration of the study.

Exclusion criteria:

  • Mothers requiring immediate inpatient care for any reason (medical or psychiatric),
  • Mothers who do not speak any of the following languages: Urdu, Punjabi, Potohari or English.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Other: Enhanced Usual Care (EUC)
EUC will comprise communicating the results to the mother's Lady Health Worker and medical officer (MO) at the Basic Health Unit (BHU) of her area, providing the MO with the WHO mental health gap (mhGAP) guidelines for the treatment of depression, and providing guidance on referral of depressed mothers to mental health services
Other: EUC
EUC will comprise communicating the results to the mother's Lady Health Worker and medical officer (MO) at the Basic Health Unit (BHU) of her area, providing the MO with the WHO mental health gap (mhGAP) guidelines for the treatment of depression, and providing guidance on referral of depressed mothers to mental health services.
Other Names:
  • Enhanced Usual Care
Experimental: THPP-P
Trial participant s who are in the THPP group will receive, in addition to EUC, 14 sessions of THPP (simplified cognitive behaviour therapy) starting from their recruitment in the third trimester until up to 5 months after child birth.
Other: EUC
EUC will comprise communicating the results to the mother's Lady Health Worker and medical officer (MO) at the Basic Health Unit (BHU) of her area, providing the MO with the WHO mental health gap (mhGAP) guidelines for the treatment of depression, and providing guidance on referral of depressed mothers to mental health services.
Other Names:
  • Enhanced Usual Care
Behavioral: THPP-P
Trial participant s who are in the THPP group will receive, in addition to Enhanced Usual Care (EUC), 14 sessions of THPP (simplified cognitive behaviour therapy) starting from their recruitment in the third trimester until up to 5 months after child birth.
Other Names:
  • Thinking Healthy Program : Peer Delivered - Pakistan

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Remission (i.e. recovery from depression)
Time Frame: 6 months post child birth
Measured with the Patient Health Questionnaire- 9 (PHQ-9)
6 months post child birth

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Remission (i.e. recovery from depression)
Time Frame: 3 months post child birth
Measured with the Patient Health Questionnaire-9 (PHQ-9)
3 months post child birth
Maternal disability
Time Frame: 3 and 6 months post child birth
Measured with the World Health Organization's Disability Assessment Schedule (WHO-DAS)
3 and 6 months post child birth
Maternal support
Time Frame: 3 and 6 months post child birth
Measured with the Multidimensional Scale of Perceived Social Support (MSPSS)
3 and 6 months post child birth
Breastfeeding rates
Time Frame: 3 and 6 months post child birth
3 and 6 months post child birth
Infant height
Time Frame: 3 and 6 months post child birth
3 and 6 months post child birth

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Liverpool

Collaborators

London School of Hygiene and Tropical Medicine
National Institute of Mental Health (NIMH)

Investigators

  • Principal Investigator: Atif Rahman, PhD, University of Liverpool

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

October 1, 2014

Primary Completion (Actual)

January 1, 2017

Study Completion (Actual)

February 1, 2017

Study Registration Dates

First Submitted

April 9, 2014

First Submitted That Met QC Criteria

April 9, 2014

First Posted (Estimate)

April 11, 2014

Study Record Updates

Last Update Posted (Actual)

December 24, 2019

Last Update Submitted That Met QC Criteria

December 20, 2019

Last Verified

December 1, 2019

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • THPP-P MH095687
  • 1U19MH095687-01 (U.S. NIH Grant/Contract)

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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