Data for Thinking Healthy Programme India trial (THPP-India)

An anonymised dataset of 280 women (one row per woman) who gave informed consent to participate in an individually-randomised, parallel, superiority, controlled trial in Goa, India in 2014-2016. The intervention was an adapted version of the Thinking Healthy Programme, delivered by peers; the control was enhanced usual care. Further details are available in the published protocol and paper. The dataset contains records of variables on stratified randomisation, socio-demographic information, depression and related outcomes, and therapy adherence. Visits occurred at baseline, and 3 and 6 months post-natal

Mother-to-mother therapy in India and Pakistan: adaptation and feasibility evaluation of the peer-delivered Thinking Healthy Programme.

BACKGROUND: Perinatal 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. METHODS: The 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. RESULTS: Most 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. CONCLUSIONS: The 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 REGISTRATION: Pakistan Trial: ClinicalTrials.gov Identifier: NCT02111915 (9 April 2014), India Trial: ClinicalTrials.gov Identifier: NCT02104232 (1 April 2014)

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.

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)

Delivering the Thinking Healthy Programme for perinatal depression through peers: an individually randomised controlled trial in India

Background The Thinking Healthy Programme (THP) is a psychological intervention recommended for the treatment of perinatal depression. However, efforts to integrate the intervention at scale into the routines of community health workers who delivered the THP when it was first evaluated were compromised by the competing responsibilities of community health workers. We aimed to assess the effectiveness and cost-effectiveness of THP peer-delivered (THPP) in Goa, India. Methods In this single-blind, individually randomised controlled trial, we recruited pregnant women aged 18 years or older who scored at least 10 on the Patient Health Questionnaire-9 (PHQ-9) from antenatal clinics in Goa. Participants were randomly allocated (1:1) to receive enhanced usual care (EUC; so-called because, in India, perinatal depression is not typically treated) only (control group) or THPP in addition to EUC (intervention group) in randomly sized blocks that were stratified by area of residence (urban or rural). Group allocations were concealed from participants and researchers before assignments were made by use of sequentially numbered opaque envelopes. The primary outcomes were the severity of depressive symptoms (assessed by PHQ-9 score) and the prevalence of remission (defined as a PHQ-9 score of less than 5) in participants with available data 6 months after childbirth, which was assessed by researchers who were masked to treatment allocations. We analysed outcomes by intention to treat, adjusting for covariates that were defined a priori or that showed imbalance at baseline. The trial is registered with ClinicalTrials.gov, number NCT02104232. Findings Between Oct 24, 2014, and June 24, 2016, we assessed 118 260 women for their eligibility for screening, of whom 111 851 (94·6%) women were ineligible. 6409 (5·4%) women were eligible for screening and 6369 (99·4%) of these women consented to be screened with the PHQ-9 (40 women did not consent), of whom 333 (5·2%) screened positive for depression (defined as a PHQ-9 score of at least 10). We enrolled 280 (84·1%) women with perinatal depression; 140 women were assigned to the THPP and EUC group and 140 women to the EUC only group. The final treatment was given on May 27, 2017. The final 6-month outcome assessment was completed on June 9, 2017. At 6 months after birth, 122 (87%) women in the THPP and EUC group and 129 (92%) women in the EUC only group were assessed for the primary outcome. There was a higher prevalence of remission at 6 months after birth in the THPP and EUC group compared with the EUC only group (89 [73%] women in the intervention group vs 77 [60%] women in the control group; prevalence ratio 1·21, 95% CI 1·01 to 1·45; p=0·04), but there was no evidence of a difference in symptom severity between the groups (mean PHQ-9 score 3·47 [SD 4·49] in the intervention group vs 4·48 [5·11] in the control group; standardised mean difference −0·18, 95% CI −0·43 to 0·07; p=0·16). There was no evidence of significant differences in serious adverse events between the groups. Interpretation THPP had a moderate effect on remission from perinatal depression over the 6-month postnatal period. THPP is relatively cheap to deliver and is cost-saving through reduced health-care, time and productivity costs

Effectiveness of the Thinking Healthy Programme for perinatal depression delivered through peers: Pooled analysis of two randomized controlled trials in India and Pakistan

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

Cross-National Differences in Psychosocial Factors of Perinatal Depression: A Systematic Review of India and Japan

Perinatal depression is prevalent worldwide. However, there are few available studies that discuss the different cultural factors affecting perinatal depression within Asian countries. This study aims to compare the literature regarding related factors relating to perinatal depression in India and Japan, and to synthesize the evidence common to both countries in addition to the country-specific evidence. We conducted a systematic review using several databases (CINAHL, MEDLINE, Pubmed, Ovid, SCOPUS, IndMED, and ICHUSI). Keywords were “antenatal depression” or “postpartum depression”, and “India” or “Japan”. Both Japanese and English language papers were reviewed. The identified evidence was compared between the two countries, as well as with non-Asian countries based on previous reports. In total, 15 articles on India and 35 on Japan were reviewed. Although several factors were shared between the two countries as well as with other non-Asian countries (vulnerable personality, being abused, age, marital conflict, and lower socio-demographic status), some differing factors were identified between India and Japan and non-Asian countries; India: poor socioeconomic status, living only with the husband, pregnancy not welcomed by the husband, a female baby, and poor relationship with in-laws; Japan: infertility treatment, conflict with work–life balance, poor relationships with biological mother or in-laws, and concerns about social relations with the other mother’s friends. To conclude, involving the family and community may be important for implementing both global standardized and culture-specific interventions. In India, treatment involving the in-laws may be effective because large family structure is a significant predictor of perinatal depression. In Japan, a family/community approach involving not only the mother’s family of origin but also the working environment is essential

Pathways to HIV testing and care in Goa, India: exploring psychosocial barriers and facilitators using mixed methods

Abstract Background Despite recognition of the importance of timely presentation to HIV care, research on pathways to care is lacking. The adverse impact of depression upon adherence to antiretroviral therapy is established. There is emerging evidence to suggest depression may inhibit initial engagement with care. However, the effect of depression and other psychosocial factors upon the pathway to care is unknown. Methods We used mixed methods to explore pathways to care of people accessing testing and treatment in Goa, India. Questionnaires including measures of common mental disorder, hazardous alcohol use, cognition and assessment of pathways to care (motivations for testing, time since they were first aware of this reason for testing, whether they had been advised to test, who had given this advice, time elapsed since this advice was given) were administered to 1934 participants at the time of HIV testing. Qualitative interviews were carried out with 15 study participants who attended the antiretroviral therapy treatment centre. Interview topic guides were designed to elicit responses that discussed barriers and facilitators of accessing testing and care. Results Pathways were often long and complex. Quantitative findings revealed that Common Mental Disorder was associated with delayed testing when advised by a Doctor (the most common pathway to testing) (AOR = 6.18, 2.16–17.70). Qualitative results showed that triggers for testing (symptoms believed to be due to HIV, and for women, illness or death of their husband) suggested that poor health, rather than awareness of risk was a key stimulus for testing. The period immediately before and after diagnosis was characterised by distress and fear. Stigma was a prominent backdrop to narratives. However, once participants had made contact with care and support (HIV services and non-governmental organisations), these systems were often effective in alleviating fear and promoting confidence in treatment and self-efficacy. Conclusion The effectiveness of formal and informal systems of support around the time of diagnosis in supporting people with mental disorder is unclear. Ways of enhancing these systems should be explored, with the aim of achieving timely presentation at HIV care for all those diagnosed with the disease

Filmed v. live social contact interventions to reduce stigma: randomised controlled trial

BackgroundDirect social contact interventions are known to reduce mental health stigma. Filmed social contact may be equally effective and have practical and cost advantages.AimsTo compare the effectiveness of a DVD, a live intervention and a lecture control, in reducing stigma, testing the hypotheses that: (a) DVD and live interventions will be equally effective; and (b) the interventions with social contact (DVD/live) will be more effective than the lecture. Cost-effectiveness, process and acceptability are also assessed.MethodStudent nurses were randomised to: (a) watch a DVD of service users/informal carers talking about their experiences, (b) watch a similar live presentation, or (c) attend a lecture. Primary outcomes were changes in attitudes (using the Mental Illness: Clinicians Attitudes Scale, MICA), emotional reactions (using the Emotional Reactions to Mental Illness Scale, ERMIS), intended proximity (using the Reported and Intended Behaviour Scale, RIBS), and knowledge (using the Social Contact Intended Learning Outcomes, SCILO), immediately after the intervention and at 4-month follow-up.ResultsFor the 216 participants, there were no differences between the DVD and live groups on MICA, ERMIS or RIBS scores. The DVD group had higher SCILO (knowledge) scores. The combined social contact group (DVD/live) had better MICA and RIBS scores than the lecture group, the latter difference maintained at 4 months. The DVD was the most cost-effective of the interventions, and the live session the most popular.ConclusionsOur hypotheses were confirmed. This study supports the wider use of filmed social contact interventions to reduce stigma about mental illness.</jats:sec