Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
NA
560 participants
INTERVENTIONAL
2014-10-31
2017-02-28
Brief Summary
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Detailed Description
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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.
Conditions
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Keywords
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
DOUBLE
Study Groups
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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
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.
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.
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.
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.
Interventions
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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.
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 Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* 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 who do not speak any of the following languages: Urdu, Punjabi, Potohari or English.
18 Years
FEMALE
No
Sponsors
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National Institute of Mental Health (NIMH)
NIH
London School of Hygiene and Tropical Medicine
OTHER
University of Liverpool
OTHER
Responsible Party
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Atif Rahman
Prof Atif Rahman
Principal Investigators
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Atif Rahman, PhD
Role: PRINCIPAL_INVESTIGATOR
University of Liverpool
Locations
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Human Development Research Foundation
Islamabad, , Pakistan
Countries
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References
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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.
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.
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.
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.
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.
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.
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.
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.
Other Identifiers
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THPP-P MH095687
Identifier Type: -
Identifier Source: org_study_id