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      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

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          Abstract

          Background

          Rates of perinatal depression (antenatal and postnatal depression) in South Asia are among the highest in the world. The delivery of effective psychological treatments for perinatal depression through existing health systems is a challenge due to a lack of human 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; THPP), for women with moderate to severe perinatal depression in rural and urban settings in Pakistan and India.

          Methods/Design

          THPP is evaluated with two randomised controlled trials: a cluster trial in Rawalpindi, Pakistan, and an individually randomised trial in Goa, India. Trial participants are pregnant women who are registered with the lady health workers in the study area in Pakistan and pregnant women attending outpatient antenatal clinics in India. They will be screened using the patient health questionnaire-9 (PHQ-9) for depression 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 women in Pakistan and India, respectively. Women in the intervention arm (THPP) 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). Women 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 depression treatment, and providing the woman with her diagnosis and information on how to seek help for herself. The primary outcomes are remission and severity of depression symptoms at the 6-month postnatal follow-up. Secondary outcomes include remission and severity of depression symptoms at the 3-month postnatal follow-up, functional disability, perceived social support, breastfeeding rates, infant 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 depression. The trials have the unique opportunity to overcome the shortage of human 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)

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          Most cited references32

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          Prevalence and determinants of common perinatal mental disorders in women in low- and lower-middle-income countries: a systematic review.

          To review the evidence about the prevalence and determinants of non-psychotic common perinatal mental disorders (CPMDs) in World Bank categorized low- and lower-middle-income countries. Major databases were searched systematically for English-language publications on the prevalence of non-psychotic CPMDs and on their risk factors and determinants. All study designs were included. Thirteen papers covering 17 low- and lower-middle-income countries provided findings for pregnant women, and 34, for women who had just given birth. Data on disorders in the antenatal period were available for 9 (8%) countries, and on disorders in the postnatal period, for 17 (15%). Weighted mean prevalence was 15.6% (95% confidence interval, CI: 15.4-15.9) antenatally and 19.8% (19.5-20.0) postnatally. Risk factors were: socioeconomic disadvantage (odds ratio [OR] range: 2.1-13.2); unintended pregnancy (1.6-8.8); being younger (2.1-5.4); being unmarried (3.4-5.8); lacking intimate partner empathy and support (2.0-9.4); having hostile in-laws (2.1-4.4); experiencing intimate partner violence (2.11-6.75); having insufficient emotional and practical support (2.8-6.1); in some settings, giving birth to a female (1.8-2.6), and having a history of mental health problems (5.1-5.6). Protective factors were: having more education (relative risk: 0.5; P = 0.03); having a permanent job (OR: 0.64; 95% CI: 0.4-1.0); being of the ethnic majority (OR: 0.2; 95% CI: 0.1-0.8) and having a kind, trustworthy intimate partner (OR: 0.52; 95% CI: 0.3-0.9). CPMDs are more prevalent in low- and lower-middle-income countries, particularly among poorer women with gender-based risks or a psychiatric history.
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            Impact of maternal depression on infant nutritional status and illness: a cohort study.

            The risk for emotional and behavioral problems is known to be high among children of depressed mothers, but little is known about the impact of prenatal and postnatal depression on the physical health of infants. To determine whether maternal depression is a risk factor for malnutrition and illness in infants living in a low-income country. Prospective cohort study. Rural community in Rawalpindi, Pakistan. Six hundred thirty-two physically healthy women were assessed in their third trimester of pregnancy to obtain at birth a cohort of 160 infants of depressed mothers and 160 infants of psychologically well mothers. All infants were weighed and measured at birth and at 2, 6, and 12 months of age, and they were monitored for episodes of diarrhea and acute respiratory infections. The mothers' mental states were reassessed at 2, 6, and 12 months. Data were collected on potential confounders of infant outcomes, such as birth weight and socioeconomic status. Infants of prenatally depressed mothers showed significantly more growth retardation than controls at all time points. The relative risks for being underweight (weight-for-age z score of less than -2) were 4.0 (95% confidence interval [CI], 2.1 to 7.7) at 6 months of age and 2.6 (95% CI, 1.7 to 4.1) at 12 months of age, and the relative risks for stunting (length-for-age z score of less than -2) were 4.4 (95% CI, 1.7 to 11.4) at 6 months of age and 2.5 (95% CI, 1.6 to 4.0) at 12 months of age. The relative risk for 5 or more diarrheal episodes per year was 2.4 (95% CI, 1.7 to 3.3). Chronic depression carried a greater risk for poor outcome than episodic depression. The associations remained significant after adjustment for confounders by multivariate analyses. Maternal depression in the prenatal and postnatal periods predicts poorer growth and higher risk of diarrhea in a community sample of infants. As depression can be identified relatively easily, it could be an important marker for a high-risk infant group. Early treatment of prenatal and postnatal depression could benefit not only the mother's mental health but also the infant's physical health and development.
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              Postnatal depression and its effects on child development: a review of evidence from low- and middle-income countries.

              It is well established that postnatal depression (PND) is prevalent in high-income countries and is associated with negative personal, family and child developmental outcomes. Here, studies on the prevalence of maternal PND in low- and middle-income countries are reviewed and a geographical prevalence map is presented. The impact of PND upon child outcomes is also reviewed. The available evidence suggests that rates of PND are substantial, and in many regions, are higher than those reported for high-income countries. An association between PND and adverse child developmental outcomes was identified in many of the countries examined. Significant heterogeneity in prevalence rates and impact on child outcomes across studies means that the true extent of the disease burden is still unclear. Nonetheless, there is a compelling case for the implementation of interventions to reduce the impact of PND on the quality of the mother-infant relationship and improve child outcomes.
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                Author and article information

                Contributors
                siham.sikander@hdrfoundation.org
                anisha.lazarus@sangath.in
                omer.bangash@hdrfoundation.org
                daniela.fuhr@lshtm.ac.uk
                benedict.weobong@lshtm.ac.uk
                revathi.krishna@sangath.in
                ikhlaq.malik@hdrfoundation.org
                helen.weiss@lshtm.ac.uk
                lprice@mail.nih.gov
                atif.rahman@liverpool.ac.uk
                vikram.patel@lshtm.ac.uk
                Journal
                Trials
                Trials
                Trials
                BioMed Central (London )
                1745-6215
                25 November 2015
                25 November 2015
                2015
                : 16
                : 534
                Affiliations
                [ ]Human Development Research Foundation, Islamabad, Pakistan
                [ ]Sangath, , Goa, India
                [ ]Faculty of Epidemiology and Population Health, London School of Hygiene and Tropical Medicine, London, UK
                [ ]Department of Health and Human Services, National Institute of Mental Health, National Institutes of Health, Bethesda, Maryland, USA
                [ ]Institute of Psychology, Health and Society, University of Liverpool, Liverpool, UK
                [ ]Centre for Chronic Conditions and Injuries, Public Health Foundation of India, Delhi NCR, India
                Article
                1063
                10.1186/s13063-015-1063-9
                4659202
                26604001
                cedc6ef7-bd15-432c-b389-5be5861cc1b4
                © Sikander et al. 2015

                Open AccessThis article is distributed under the terms of the Creative Commons Attribution 4.0 International License ( http://creativecommons.org/licenses/by/4.0/), which permits unrestricted use, distribution, and reproduction in any medium, provided you give appropriate credit to the original author(s) and the source, provide a link to the Creative Commons license, and indicate if changes were made. The Creative Commons Public Domain Dedication waiver ( http://creativecommons.org/publicdomain/zero/1.0/) applies to the data made available in this article, unless otherwise stated.

                History
                : 7 July 2015
                : 17 November 2015
                Categories
                Study Protocol
                Custom metadata
                © The Author(s) 2015

                Medicine
                thinking healthy programme,psychological treatment,peers,non-mental health professionals,perinatal depression,task-shifting,randomised trials,low and middle income countries

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