Background:The Thinking Healthy Programme (THP) is a psychological intervention recommended for the treatment of perinatal depression. We assessed the effectiveness and cost-effectiveness of THP delivered by peers (THPP) in Goa, India. Methods:In this single-blind, individually-randomised controlled trial, we recruited pregnant women aged ≥18 years attending antenatal clinics, who scored ≥10 on the Patient Health Questionnaire (PHQ-9). Participants were randomly allocated (1:1) to THPP plus enhanced usual care (EUC), or to EUC alone in randomly-sized blocks, stratified by area of residence. Allocation was concealed using sequentiallynumbered opaque envelopes. Primary outcomes were severity of depressive symptoms (PHQ-9 score) and remission (PHQ-9 score <5) 6 months post-birth assessed by researchers masked to the treatment allocation. Analyses were by intention to treat, adjusting for covariates defined a priori or that showed imbalance at baseline. The trial is registered with ClinicalTrials.gov (NCT02104232).Findings: 280 women were enrolled between 24th October 2014 and 22nd June 2016 (140 per group). At 6 months, 122 (87%) and 129 (92%) women in the THPP plus EUC, and EUC alone groups, respectively, contributed primary outcome data. There was evidence of higher prevalence of remission at 6 months in the THPP plus EUC versus EUC alone group (n=89 (73%) versus n=77 (60%), respectively; prevalence ratio (PR)=1·21; 95% confidence interval (CI) 1·01 to 1·45, p=0·04), but weaker evidence for lower symptom severity (mean 3·47, standard deviation (SD) 4·49 versus 4·48 (SD=5·11), respectively; standardised mean difference (SMD)=-0·18; 95% CI -0·43 to 0·07, p=0·16).Repeated measures analyses over the duration of the trial (measured at 3 and 6 months post-birth) showed beneficial effects on symptom severity (SMD -0·37, 95% CI -0·88 to -0·24, p=0·01), remission (PR=1·21, 95% CI 1·01 to 1·41, p=0·02), WHO-Disability Assessment Schedule (WHO-DAS) scores (SMD=-0·32, 95% CI -0·76 to -0·21, p=0·02) and Multidimensional Scale of Perceived Social Support (MSPSS) scores (SMD=0·51, 95% CI 0·43 to 1·20, p=0·02). . The incremental societal cost per unit improvement on PHQ-9 was -US$ 29·64 (95% CI-32·88 to -26·41) at 3 months, and -US$93·53 (95% CI -180·21 to -6·84) for the whole duration of the trial, with a 87% likelihood of being costsaving in the study setting. The mean cost of providing THPP was US$ 1·36 per beneficiary (95% CI 1·32 to 1·39). There was no evidence of differences in serious adverse events by group, except stigmatisation was more often reported in the EUC alone (9%) versus the THPP plus EUC group (4%; p=0·08).Interpretation: THPP had a moderate effect on symptom severity and remission from perinatal depression over the 6 month post-natal period. THPP is relatively cheap to deliver and pays for itself through reduced health care, time and productivity costs. Funding: NIMH

Background: Most people with stroke in India have no access to organised

BackgroundPerinatal depression is highly prevalent in South Asia. Although effective and culturally feasible interventions exist, a key bottleneck for scaled-up delivery is lack of trained human resource. The aim of this study was to adapt an evidence-based intervention so that local women from the community (peers) could be trained to deliver it, and to test the adapted intervention for feasibility in India and Pakistan.MethodsThe study was conducted in Rawalpindi, Pakistan and Goa, India. To inform the adaptation process, qualitative data was collected through 7 focus groups (four in Pakistan and three in India) and 61 in-depth interviews (India only). Following adaptation, the intervention was delivered to depressed mothers (20 in Pakistan and 24 in India) for six months through 8 peers in Pakistan and nine in India. Post intervention data was collected from depressed mothers and peers through 41 in-depth interviews (29 in Pakistan and 12 in India) and eight focus groups (one in Pakistan and seven in India). Data was analysed using Framework Analysis approach.ResultsMost mothers perceived the intervention to be acceptable, useful, and viewed the peers as effective delivery-agents. The simple format using vignettes, pictures and everyday terms to describe distress made the intervention easy to understand and deliver. The peers were able to use techniques for behavioural activation with relative ease. Both the mothers and peers found that shared life-experiences and personal characteristics greatly facilitated the intervention-delivery. A minority of mothers had concerns about confidentiality and stigma related to their condition, and some peers felt the role was emotionally challenging.ConclusionsThe study demonstrates the feasibility of using peers to provide interventions for perinatal depression in two South Asian settings. Peers can be a potential resource to deliver evidence-based psychosocial interventions.Trial registrationPakistan Trial: ClinicalTrials.gov Identifier: NCT02111915 (9 April 2014), India Trial: ClinicalTrials.gov Identifier: NCT02104232 (1 April 2014).

BackgroundRates 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/DesignTHPP 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.DiscussionThe 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 registrationPakistan Trial: ClinicalTrials.gov Identifier: NCT02111915 (9 April 2014)India Trial: ClinicalTrials.gov Identifier: NCT02104232 (1 April 2014)

When one parent kills the other, children are confronted with multiple losses, involving their attachment figures and their direct living environment. In these complex situations, potentially drastic decisions are made, for example, regarding new living arrangements and contact with the perpetrating parent. We aimed to synthesize the empirical literature on children's mental health and well-being after parental intimate partner homicide. A systematic search identified 17 relevant peer-reviewed articles (13 independent samples). We recorded the theoretical background, methodology, and sample characteristics of the studies, and extracted all child outcomes as well as potential risk and protective factors. Children's outcomes varied widely and included psychological, social, physical, and academic consequences (e.g., post-traumatic stress, attachment difficulties, weight and appetite changes, and drops in school grades). Potential risk and protective factors for children's outcomes included 10 categories of pre-, peri-, and post-homicide characteristics such as cultural background of the family, whether the child witnessed the homicide, and the level of conflict between the families of the victim and the perpetrator. We integrated the findings into a conceptual model of risk factors to direct clinical reflection and further research.

Background:The Thinking Healthy Programme (THP) is recommended to treat perinatal depression in resource-limited settings, but scale-up is hampered by a paucity of community health workers.THP was adapted for peer-delivery (THPP) and evaluated in two randomized controlled trials in India and Pakistan. Our aim was to estimate the effectiveness of THPP on maternal outcomes across these two settings, and evaluate effect-modification by country and other pre-defined covariates.Methods: Participants were pregnant women aged≥18 years with depression (Patient Health Questionnaire (PHQ-9) score≥10), randomized to THPP plus enhanced usual care (EUC) or EUC-only.Primary outcomes were symptom severity and remission (PHQ-9 score<5) 6 months post-childbirth.Secondary outcomes included further measures of depression, disability and social support at 3 and 6 months post-childbirth.Results: Among 850 women (280 India; 570 Pakistan), 704 (83%) attended 6-month follow-up.Participants in the intervention arm had lower symptom severity (PHQ-9 score adjusted mean difference -0.78 (95% confidence interval -1.47,-0.09)) and higher odds of remission (adjusted odds ratio 1.35 (1.02,1.78)) versus EUC-only. There was a greater intervention effect on remission among women with short chronicity of depression, and those primiparous. There were beneficial intervention effects across multiple secondary outcomes. Limitations:The trials were not powered to assess effect-modifications. 10-20% of participants were missing outcome data. Conclusions:This pooled analysis demonstrates the effectiveness, acceptability and feasibility of THPP, which can be scaled-up within a stepped-care approach by engaging with the existing health care systems and the communities to address the treatment gap for perinatal depression in resource-limited settings.

Background. The aims of the current study were three-fold: i) to estimate the reliability and predictive validity of a therapy quality measure for use by peers; ii) to assess the extent to which peer delivery agents could be trained to evaluate their peers' counsellors as reliably as experts; and iii) to identify barriers and facilitators of several implemented models of peer supervision. Methods. 26 peers (called 'Sakhis' in the study context), with no previous experience or formal training in mental health care delivery, were trained by experts to deliver the Thinking Healthy Program Peerdelivered (THPP) and conduct peer-led supervision. Using the Therapy Quality Scale (TQS)-an 18 item Likert scale (0-2) measuring both general and treatment-specific skills-both peers and experts independently rated 167 individual sessions to estimate: a) the psychometric properties of TQS; and b) the mean difference between peer and expert TQS ratings; these data were analyzed using SAS 9.3. This was complemented with qualitative data (two rounds of in-depth interviews with four experts and focus group discussions with all Sakhis) which were analyzed using framework analysis. Results. We observed good internal consistency on TQS ratings among expert (α=0.814) and Sakhis (α=0.843) and good to excellent scores of inter-rater reliability among experts (ICC=0.779) and Sakhis (ICC=0.714). TQS ratings were not significantly related to patient depressive symptoms at 6-months post-child birth but were significantly related to patient activation scores (r=0.375, p<0.01 for treatment-specific skills and 0.313, p<0.01 for general skills) at 3-months post-child birth, which in turn were significantly related to depressive symptom scores at 6-months post-child birth (r=-0.455, p<0.001), highlighting a potential temporal pathway between therapy quality, patient behaviours and patient outcomes. Following additional training and with growing expertise, Sakhis eventually evaluated their peers' counselling sessions as reliably as experts-demonstrating no significant mean differences on general (t=-0.42, p>0.05) or treatment-specific (t=-1.44, p>0.05) subscale scores. Qualitative findings were also consistent between experts and Sakhis: barriers included peers' initial difficulties in rating the TQS and leading supervision which declined over time. Most Sakhis and experts reported the benefits of using a structured scale to rate therapy quality which in turn facilitated consistent and relevant feedback and motivation to ultimately improve Sakhis' counselling skills. In addition, most Sakhis and experts found that peer supervision methods were acceptable and feasible, particularly when linked to financial incentives and expert supervisor. Conclusion.With time, non-specialist or lay providers can be trained to implement peer supervision and assess therapy quality as reliably as experts using a psychometrically-sound measure. However, peer supervision with experts was more preferred than peer supervision without experts to facilitate structured, rel...

Background:The Thinking Healthy Programme (THP) is a psychological intervention recommended for the treatment of perinatal depression. We assessed the effectiveness and cost-effectiveness of THP delivered by peers (THPP) in Goa, India. Methods:In this single-blind, individually-randomised controlled trial, we recruited pregnant women aged ≥18 years attending antenatal clinics, who scored ≥10 on the Patient Health Questionnaire (PHQ-9). Participants were randomly allocated (1:1) to THPP plus enhanced usual care (EUC), or to EUC alone in randomly-sized blocks, stratified by area of residence. Allocation was concealed using sequentiallynumbered opaque envelopes. Primary outcomes were severity of depressive symptoms (PHQ-9 score) and remission (PHQ-9 score <5) 6 months post-birth assessed by researchers masked to the treatment allocation. Analyses were by intention to treat, adjusting for covariates defined a priori or that showed imbalance at baseline. The trial is registered with ClinicalTrials.gov (NCT02104232).Findings: 280 women were enrolled between 24th October 2014 and 22nd June 2016 (140 per group). At 6 months, 122 (87%) and 129 (92%) women in the THPP plus EUC, and EUC alone groups, respectively, contributed primary outcome data. There was evidence of higher prevalence of remission at 6 months in the THPP plus EUC versus EUC alone group (n=89 (73%) versus n=77 (60%), respectively; prevalence ratio (PR)=1·21; 95% confidence interval (CI) 1·01 to 1·45, p=0·04), but weaker evidence for lower symptom severity (mean 3·47, standard deviation (SD) 4·49 versus 4·48 (SD=5·11), respectively; standardised mean difference (SMD)=-0·18; 95% CI -0·43 to 0·07, p=0·16).Repeated measures analyses over the duration of the trial (measured at 3 and 6 months post-birth) showed beneficial effects on symptom severity (SMD -0·37, 95% CI -0·88 to -0·24, p=0·01), remission (PR=1·21, 95% CI 1·01 to 1·41, p=0·02), WHO-Disability Assessment Schedule (WHO-DAS) scores (SMD=-0·32, 95% CI -0·76 to -0·21, p=0·02) and Multidimensional Scale of Perceived Social Support (MSPSS) scores (SMD=0·51, 95% CI 0·43 to 1·20, p=0·02). . The incremental societal cost per unit improvement on PHQ-9 was -US$ 29·64 (95% CI-32·88 to -26·41) at 3 months, and -US$93·53 (95% CI -180·21 to -6·84) for the whole duration of the trial, with a 87% likelihood of being costsaving in the study setting. The mean cost of providing THPP was US$ 1·36 per beneficiary (95% CI 1·32 to 1·39). There was no evidence of differences in serious adverse events by group, except stigmatisation was more often reported in the EUC alone (9%) versus the THPP plus EUC group (4%; p=0·08).Interpretation: THPP had a moderate effect on symptom severity and remission from perinatal depression over the 6 month post-natal period. THPP is relatively cheap to deliver and pays for itself through reduced health care, time and productivity costs. Funding: NIMH