Thinking Healthy Program - Peer Delivered (Pakistan)

NCT02111915 | Completed DMC

• 2 other identifiers: THPP-P MH0956871U19MH095687-01
• Study Type: interventional
• Target: 560
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Unipolar Depression

Keywords

Maternal depression

Outcome Measures

Primary Outcomes (1)

• Remission (i.e. recovery from depression)

  Measured with the Patient Health Questionnaire- 9 (PHQ-9)

  6 months post child birth

Secondary Outcomes (5)

• Remission (i.e. recovery from depression)

  3 months post child birth

• Maternal disability

  3 and 6 months post child birth

• Maternal support

  3 and 6 months post child birth

• Breastfeeding rates

  3 and 6 months post child birth

• Infant height

  3 and 6 months post child birth

Study Arms (2)

Enhanced Usual Care (EUC)

OTHER

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

THPP-P

EXPERIMENTAL

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.

Behavioral: THPP-P; Other: EUC

Interventions

THPP-P BEHAVIORAL

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.

Also known as: Thinking Healthy Program : Peer Delivered - Pakistan

THPP-P

EUC OTHER

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.

Also known as: Enhanced Usual Care

Enhanced Usual Care (EUC); THPP-P

Eligibility Criteria

• Age: 18 Years+
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• University of Liverpool: lead
• National Institute of Mental Health (NIMH): collaborator
• London School of Hygiene and Tropical Medicine: collaborator

Study Sites (1)

Human Development Research Foundation

Islamabad, Pakistan

Location

Related Publications (8)

• LeMasters K, Bates LM, Chung EO, Gallis JA, Hagaman A, Scherer E, Sikander S, Staley BS, Zalla LC, Zivich PN, Maselko J. Adverse childhood experiences and depression among women in rural Pakistan. BMC Public Health. 2021 Feb 25;21(1):400. doi: 10.1186/s12889-021-10409-4.

  PMID: 33632175 DERIVED

• 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.

  PMID: 32090783 DERIVED

• LeMasters K, Andrabi N, Zalla L, Hagaman A, Chung EO, Gallis JA, Turner EL, Bhalotra S, Sikander S, Maselko J. Maternal depression in rural Pakistan: the protective associations with cultural postpartum practices. BMC Public Health. 2020 Jan 15;20(1):68. doi: 10.1186/s12889-020-8176-0.

  PMID: 31941468 DERIVED

• Scherer E, Hagaman A, Chung E, Rahman A, O'Donnell K, Maselko J. The relationship between responsive caregiving and child outcomes: evidence from direct observations of mother-child dyads in Pakistan. BMC Public Health. 2019 Feb 28;19(1):252. doi: 10.1186/s12889-019-6571-1.

  PMID: 30819173 DERIVED

• 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.

  PMID: 30686386 DERIVED

• Atif N, Krishna RN, Sikander S, Lazarus A, Nisar A, Ahmad I, Raman R, Fuhr DC, Patel V, Rahman A. Mother-to-mother therapy in India and Pakistan: adaptation and feasibility evaluation of the peer-delivered Thinking Healthy Programme. BMC Psychiatry. 2017 Feb 23;17(1):79. doi: 10.1186/s12888-017-1244-z.

  PMID: 28231791 DERIVED

• Turner EL, Sikander S, Bangash O, Zaidi A, Bates L, Gallis J, Ganga N, O'Donnell K, Rahman A, Maselko J. The effectiveness of the peer delivered Thinking Healthy Plus (THPP+) Programme for maternal depression and child socio-emotional development in Pakistan: study protocol for a three-year cluster randomized controlled trial. Trials. 2016 Sep 8;17(1):442. doi: 10.1186/s13063-016-1530-y.

  PMID: 27608926 DERIVED

• Sikander S, Lazarus A, Bangash O, Fuhr DC, Weobong B, Krishna RN, Ahmad I, Weiss HA, Price L, Rahman A, Patel V. The effectiveness and cost-effectiveness of the peer-delivered Thinking Healthy Programme for perinatal depression in Pakistan and India: the SHARE study protocol for randomised controlled trials. Trials. 2015 Nov 25;16:534. doi: 10.1186/s13063-015-1063-9.

  PMID: 26604001 DERIVED

MeSH Terms

Conditions

Depressive Disorder

Interventions

meso-tetra-(4-hydroxyphenyl)porphyrin

Condition Hierarchy (Ancestors)

Mood Disorders; Mental Disorders

Study Officials

• Atif Rahman, PhD

  University of Liverpool

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Prof Atif Rahman

Study Record Dates

• First Submitted: April 9, 2014
• First Posted: April 11, 2014
• Study Start: October 1, 2014
• Primary Completion: January 1, 2017
• Study Completion: February 1, 2017
• Last Updated: December 24, 2019

Record last verified: 2019-12

Locations

PA (1)