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

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ClinicalTrials.gov Identifier: NCT02111915
Recruitment Status : Unknown
Verified September 2015 by Atif Rahman, University of Liverpool.
Recruitment status was:  Recruiting
First Posted : April 11, 2014
Last Update Posted : September 18, 2015
Sponsor:
Collaborators:
National Institute of Mental Health (NIMH)
London School of Hygiene and Tropical Medicine
Information provided by (Responsible Party):
Atif Rahman, University of Liverpool

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.

Condition or disease Intervention/treatment Phase
Unipolar Depression Behavioral: THPP-P Other: EUC Phase 2 Phase 3

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  (Clinical Trial)
Estimated Enrollment : 560 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Thinking Healthy Program - Peer Delivered in Pakistan
Study Start Date : October 2014
Estimated Primary Completion Date : October 2016
Estimated Study Completion Date : December 2016

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
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 Name: 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.
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 Name: Thinking Healthy Program : Peer Delivered - Pakistan

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 Name: Enhanced Usual Care




Primary Outcome Measures :
  1. Remission (i.e. recovery from depression) [ Time Frame: 6 months post child birth ]
    Measured with the Patient Health Questionnaire- 9 (PHQ-9)


Secondary Outcome Measures :
  1. Remission (i.e. recovery from depression) [ Time Frame: 3 months post child birth ]
    Measured with the Patient Health Questionnaire-9 (PHQ-9)

  2. Maternal disability [ Time Frame: 3 and 6 months post child birth ]
    Measured with the World Health Organization's Disability Assessment Schedule (WHO-DAS)

  3. Maternal support [ Time Frame: 3 and 6 months post child birth ]
    Measured with the Multidimensional Scale of Perceived Social Support (MSPSS)

  4. Breastfeeding rates [ Time Frame: 3 and 6 months post child birth ]
  5. Infant height [ Time Frame: 3 and 6 months post child birth ]


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02111915


Contacts
Contact: Atif Rahman, PhD Atif.Rahman@liverpool.ac.uk
Contact: Siham Sikander, PhD siham.sikander@hdrfoundation.org

Locations
Pakistan
Human Development Research Foundation Recruiting
Islamabad, Pakistan
Contact: Siham Sikander, PhD       siham.sikander@hdrfoundation.org   
Contact: Omer FK Bangash, MPH       omer.bangash@hdrfoundation.org   
Principal Investigator: Siham Sikander, PhD         
Sponsors and Collaborators
University of Liverpool
National Institute of Mental Health (NIMH)
London School of Hygiene and Tropical Medicine
Investigators
Principal Investigator: Atif Rahman, PhD University of Liverpool

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Atif Rahman, Prof Atif Rahman, University of Liverpool
ClinicalTrials.gov Identifier: NCT02111915     History of Changes
Other Study ID Numbers: THPP-P MH095687
1U19MH095687-01 ( U.S. NIH Grant/Contract )
First Posted: April 11, 2014    Key Record Dates
Last Update Posted: September 18, 2015
Last Verified: September 2015

Keywords provided by Atif Rahman, University of Liverpool:
Maternal depression

Additional relevant MeSH terms:
Depression
Depressive Disorder
Behavioral Symptoms
Mood Disorders
Mental Disorders