The effectiveness and cost-effectiveness of the peer-delivered Thinking Healthy Programme for perinatal XXXX in Pakistan and India: the SHARE study protocol for randomised controlled trials.

@entity1 @entity308 @entity72303
BACKGROUND: Rates of perinatal @entity308 ( @entity308 ) in South Asia are among the highest in the world. The delivery of effective psychological treatments for perinatal @entity308 through existing health systems is a challenge due to a lack of @entity1 resources. This paper reports on a trial protocol that aims to evaluate the effectiveness and cost-effectiveness of the Thinking Healthy Programme delivered by peers (Thinking Healthy Programme Peer-delivered; @entity72303 ), for @entity1 with moderate to severe perinatal @entity308 in rural and urban settings in Pakistan and India. METHODS/DESIGN: @entity72303 is evaluated with two randomised controlled trials: a cluster trial in Rawalpindi, Pakistan, and an individually randomised trial in Goa, India. Trial @entity1 are pregnant @entity1 who are registered with the lady health workers in the study area in Pakistan and pregnant @entity1 attending outpatient antenatal clinics in India. They will be screened using the @entity1 health questionnaire-9 (PHQ-9) for @entity308 symptoms and will be eligible if their PHQ-9 is equal to or greater than 10 (PHQ-9   >=    10). The sample size will be 560 and 280 @entity1 in Pakistan and India, respectively. @entity1 in the intervention arm ( @entity72303 ) will be offered ten individual and four group sessions (Pakistan) or 6-14 individual sessions (India) delivered by a peer (defined as a mother from the same community who is trained and supervised in delivering the intervention). @entity1 in the control arm (enhanced usual care) will receive health care as usual, enhanced by providing the gynaecologist or primary-health facilities with adapted WHO mhGAP guidelines for @entity308 treatment, and providing the @entity1 with her diagnosis and information on how to seek help for herself. The primary outcomes are remission and severity of @entity308 symptoms at the 6-month postnatal follow-up. Secondary outcomes include remission and severity of @entity308 symptoms at the 3-month postnatal follow-up, functional disability, perceived social support, breastfeeding rates, @entity1 height and weight, and costs of health care at the 3- and 6-month postnatal follow-ups. The primary analysis will be intention-to-treat. DISCUSSION: The trials have the potential to strengthen the evidence on the effectiveness and cost-effectiveness of an evidence-based psychological treatment recommended by the World Health Organisation and delivered by peers for perinatal @entity308 . The trials have the unique opportunity to overcome the shortage of @entity1 resources in global mental health and may advance our understanding about the use of peers who work in partnership with the existing health systems in low-resource settings. TRIAL REGISTRATION: Pakistan Trial: ClinicalTrials.gov Identifier: NCT02111915 (9 April 2014) India Trial: ClinicalTrials.gov Identifier: NCT02104232 (1 April 2014).
