Technology-assisted cognitive-behavior therapy delivered by peers versus standard cognitive behavior therapy delivered by community health workers for perinatal depression: study protocol of a cluster randomized controlled non-inferiority trial.

BACKGROUND: The lack of trained mental health professionals is a key barrier to scale-up of evidence-based psychological interventions in low and middle-income countries. We have developed an app that allows a peer with no prior experience of health-care delivery to deliver the cognitive therapy-based intervention for perinatal depression, the Thinking Healthy Programme (THP). This trial aims to assess the effectiveness and cost-effectiveness of this Technology-assisted peer-delivered THP versus standard face-to-face Thinking Healthy Programme delivered by trained health workers. METHODS: We will employ a non-inferiority stratified cluster randomized controlled trial design comparing the two formats of intervention delivery. A total of 980 women in the second or third trimester of pregnancy with a diagnosis of Major Depressive Episode, evaluated with the Structured Clinical Interview for DSM-V Disorders (SCID), will be recruited into the trial. The unit of randomization will be 70 village clusters randomly allocated in a 1:1 ratio to the intervention and control arms. The primary outcome is defined as remission from major depressive episode at 3 months postnatal measured with the SCID. Data will also be collected on symptoms of anxiety, disability, quality of life, service use and costs, and infant-related outcomes such as exclusive breastfeeding and immunization rates. Data will be collected on the primary outcome and selected secondary outcomes (depression and anxiety scores, exclusive breastfeeding) at 6 months postnatal to evaluate if the improvements are sustained in the longer-term. We are especially interested in sustained improvement (recovery) from major depressive episode. DISCUSSION: This trial will evaluate the effectiveness and cost-effectiveness of a technology-assisted peer-delivered cognitive behavioral therapy-based intervention in rural Pakistan. If shown to be effective, the novel delivery format could play a role in reducing the treatment gap for perinatal depression and other common mental disorders in LMIC. TRIAL REGISTRATION: The trial was registered at Clinicaltrials.gov (NCT05353491) on 29 April 2022.

Adaptation and integration of the thinking healthy programme into pregnancy schools in Istanbul, Turkey.

BACKGROUND: Perinatal mental health is a major public health concern. In Turkey, public hospitals operate pregnancy schools which provides an opportunity to integrate an evidence-based Thinking Healthy Programme (THP) for perinatal depression. The aim of this study is to adapt the THP for universal use in the group setting and to understand its acceptability and feasibility for integration into the existing antenatal care programme for both face-to-face and online delivery. METHODS: Following an expert-led adaptation process using the Bernal Framework, field testing was conducted on a group of women and facilitators followed by in-depth interviews (n:8) and group discussions (n = 13). Data were analysed using Thematic Framework Analysis. RESULTS: Minor but significant adaptations were made to the individually delivered THP for use in the universal group pregnancy schools. Initial findings indicate that the THP-group version was acceptable to its target population and could be integrated into the antenatal care plan for delivery during face-to-face and online group classes. CONCLUSION: THP is transferable to the Turkish cultural and healthcare context. The THP-group version has the potential to add value to Turkey's existing perinatal healthcare programme.

Delivering the Thinking Healthy Programme as a universal group intervention integrated into routine antenatal care: a randomized-controlled pilot study.

BACKGROUND: Women with perinatal depression and their children are at increased risk of poor health outcomes. There is a need to implement non-stigmatizing interventions into existing health systems which reduce psychosocial distress during pregnancy and prevent perinatal depression. We adapted the WHO-endorsed Thinking Healthy Programme (THP) to be delivered universally to all women attending routine online pregnancy schools in Istanbul, Turkey. This study aimed to evaluate the feasibility and acceptability of this intervention. METHODS: This mixed-methods study incorporated a two-arm pilot randomized controlled trial and qualitative evaluation of the feasibility and acceptability of the adapted THP - Brief Group version (THP-BGV) to a range of stakeholders. We recruited pregnant women at 12-30 weeks' gestation through pregnancy schools within the University Hospital's catchment area. Women in the intervention arm received five online sessions of the THP-BGV delivered by antenatal nurses. The intervention employed principles of cognitive behaviour therapy to provide psychoeducation, behaviour activation, problem-solving strategies and group support to participants. In the control arm, women received usual care consisting of routine online educational pregnancy classes aided by the antenatal nurses. The women were assessed for depressive symptoms with the Edinburgh Postnatal Depression Scale at baseline and 4-6 weeks post-intervention and also evaluated for anxiety, perceived social support, partner relationship, level of disability and sleep quality. In-depth interviews were conducted with women and other key stakeholders. RESULTS: Of the 99 consecutive women referred to the pregnancy schools, 91 (91.9%) were eligible and 88 (88.8%) consented to participate in the study and were randomized. Eighty-two (83%) completed the final assessments. Our main findings were that this preventive group intervention was feasible to be integrated into routine antenatal educational classes and it was valued by the women and delivery-agents. While the study was not powered to detect differences between intervention and control conditions, we found small trends towards reduction in anxiety and depressive symptoms favoring the intervention arm. No serious adverse events were reported. CONCLUSIONS: Given the paucity of preventive interventions for perinatal depression in low and middle-income countries, a fully powered definitive randomized controlled trial of this feasible and acceptable intervention should be conducted. TRIAL REGISTRATION: The study was registered at Clinical Trails.gov ( NCT04819711 ) (Registration Date: 29/03/2021).

Prevalence of perinatal anxiety and its determinants in mainland China: A systematic review and meta-analysis.

BACKGROUND: Perinatal anxiety is among the most common mental health conditions that have a huge negative impact both on mothers and their children. This study aimed to establish summary estimates of the prevalence of perinatal anxiety and its influencing factors in Mainland China. METHODS: A systematic search was carried out from nine major English and Chinese electronic databases to identify studies published up to August 20, 2022 with data on the prevalence of perinatal anxiety. Two reviewers conducted data extraction and quality assessment. Meta-analysis was performed using a random-effects model. Subgroup and meta-regression analyses were performed when possible. RESULTS: 271 studies representing 369,477 women were included in the study. Pooled prevalence of perinatal anxiety was 17.4 % (95 % CI: 16.2 % to 18.7 %), with prenatal anxiety 17.4 % (95%CI: 16.1 % to 18.8 %) and postpartum anxiety 17.5 % (95%CI: 13.5 % to 22.4 %). However, the overall estimates presented substantial heterogeneity (I2 = 98.93 %). Qualitative summaries demonstrated some main potential risk factors of perinatal anxiety such as women with abnormal pregnancy-labor history, poor health status, pregnancy complications, and unplanned pregnancies, and some potential protective factors such as high family income, good social support, good interpersonal relationships, and history of multiple deliveries. LIMITATION: Very large heterogeneity among studies was observed in meta-synthesis, and all included studies used self-report scales to identify anxiety rather than diagnostic interviews. CONCLUSION: Varying degrees of perinatal anxiety is prevalent among Chinese women. Screening and evidence-based interventions are urgent and necessary to address this public concern and promote their health and well-being.

Standardising Training of Nurses in an Evidence-Based Psychosocial Intervention for Perinatal Depression: Randomized Trial of Electronic vs. Face-to-Face Training in China.

BACKGROUND: Rates of perinatal depression in China are high. The Thinking Healthy Programme is a WHO-endorsed, evidence-based psychosocial intervention for perinatal depression, requiring five days of face-to-face training by a specialist trainer. Given the paucity of specialist trainers and logistical challenges, standardized training of large numbers of nurses is a major challenge for scaling up. We developed an electronic training programme (e-training) which eliminates the need for specialist-led, face-to-face training. The aim of this study was to evaluate the effectiveness of the e-training compared to conventional face-to-face training in nursing students. METHODS: A single blind, non-inferiority, randomized controlled trial was conducted. One hundred nursing students from two nursing schools were randomly assigned to either e-training or conventional face-to-face training. RESULTS: E-training was not inferior to specialist-led face-to-face training immediately post-training [mean ENhancing Assessment of Common Therapeutic factors (ENACT) score (M) 45.73, standard deviation (SD) 4.03 vs. M 47.08, SD 4.53; mean difference (MD) -1.35, 95% CI; (-3.17, 0.46), p = 0.14]. There was no difference in ENACT scores at three months [M = 42.16, SD 4.85 vs. M = 42.65, SD 4.65; MD = -0.481, 95% CI; (-2.35, 1.39), p = 0.61]. CONCLUSIONS: E-training is a promising tool with comparative effectiveness to specialist-led face-to-face training. E-training can be used for training of non-specialists for evidence-based psychosocial interventions at scale and utilized where there is a shortage of specialist trainers, but practice under supervision is necessary to maintain competence. However, continued practice under supervision may be necessary to maintain competence.

Scalable Screening and Treatment Response Monitoring for Perinatal Depression in Low- and Middle-Income Countries.

Common perinatal mental disorders such as anxiety and depression are a public health concern in low- and middle-income countries. Several tools exist for screening and monitoring treatment responses, which have frequently been tested globally in clinical and research settings. However, these tools are relatively long and not practical for integration into routine data systems in most settings. This study aims to address this gap by considering three short tools: The Community Informant Detection Tool (CIDT) for the identification of women at risk, the 4-item Patient Health Questionnaire (PHQ-4) for screening women at high-risk, and the 4-item Hamilton Depression Rating Scale (HAMD-4) for measuring treatment responses. Studies in rural Pakistan showed that the CIDT offered a valid and reliable key-informant approach for the detection of perinatal depression by utilizing a network of peers and local health workers, yielding a sensitivity of 97.5% and specificity of 82.4%. The PHQ-4 had excellent psychometric properties to screen women with perinatal depression through trained community health workers, with a sensitivity of 93.4% and specificity of 91.70%. The HAMD-4 provided a good model fit and unidimensional construct for assessing intervention responses. These short, reliable, and valid tools are scalable and expected to reduce training, administrative and human resource costs to health systems.

Improving access to psychosocial interventions for perinatal depression in low- and middle-income countries: lessons from the field.

Over 90% women with perinatal depression in low and middle-income countries do not receive treatment. Scale-up of evidence-based psychosocial interventions is a key challenge. We developed the Thinking Healthy Programme (THP), a psychosocial intervention that can be delivered by non-specialist providers such as community health workers in primary and secondary care settings. Our research showed that three out of 4 women with perinatal depression who received the programme recovered, and there were beneficial effects on infant outcomes. In over a decade since the original research, policy and practice uptake of the programme globally has been promising. We describe factors contributing to this: the programme is relatively inexpensive and culturally transferable; the intervention can be integrated with existing maternal and child health programmes; the programme is amenable to 'task-sharing' via peers, nurses, community health-workers and other frontline workers; cascaded models of training and supervision, and the use of technology for training and delivery provide exciting future avenues for scaled-up implementation. These innovations are relevant to the neglected field of public mental health, especially in the post COVID19 era when rates of anxiety and depression are likely to rise globally.

Prevalence of perinatal depression and its determinants in Mainland China: A systematic review and meta-analysis.

BACKGROUND: Perinatal depression is a maternal mental health condition that is associated with various adverse health outcomes both for the mothers and the babies. The study aim was to estimate the prevalence of perinatal depression and its risks and determinants in Mainland China. METHODS: Systematic searches were conducted in 10 major databases and random effect meta-analysis was performed to achieve the pooled variance of perinatal depression. Subgroup analyses were conducted based on region, scale, methods of diagnosis and study design. Meta-regression was performed with the variables such as age, quality assessment score and gross domestic product (GDP) of the province. RESULTS: Pooled prevalence of perinatal depression was 16.3% (CI=95%; 14.7% to 18.2%, P < 0.001), with antenatal depression 19.7% (CI=95%; 15.8% to 24.2%, P < 0.001) and postnatal depression 14.8% (CI=95%; 13.1% to 16.6%, P < 0.001). Significant publication bias was found and heterogeneity was I2= 98.13%. Lower socioeconomic status, poor physical health, anxiety about pregnancy and reduced social support were major risk factors while better living conditions and higher level of education were protective factors. The prevalence of perinatal depression showed a significant increasing trend in the last decade. LIMITATIONS: The review does not include studies with small sample size (n <250). Moreover a narrative review of risk and protective factors was done, these were not included in meta-analysis. CONCLUSION: The prevalence of perinatal depression in China is similar to low and middle-income countries. Urgent attention is needed to address this public health priority in China.

Professional support during the postpartum period: primiparous mothers' views on professional services and their expectations, and barriers to utilizing professional help.

BACKGROUND: Primiparous mothers who lack of experience and knowledge of child caring, are usually overwhelmed by multifarious stressors and challenges. Although professional support is needed for primiparas, there is a gap between the necessary high-quality services and the currently provided poor services. This study aimed to explore Chinese primiparous mothers' views on professional services, identify barriers to utilizing professional support, and further understand mothers' expectations of and preferences for the delivery of professional services. METHOD: A descriptive phenomenological study design was utilized in this study, and semi-structured interviews were conducted with 28 primiparous mothers who had given birth in the first year period before the interview and were selected from two community health centres in Xi'an city, Shaanxi Province, Northwest China. Each conversational interview lasted between 20 and 86 min. Colaizzi's seven-step phenomenological approach was used to analyse the data. RESULTS: Three major themes were identified: (a) dissatisfaction with current professional services for postpartum mothers, (b) likelihood of health care professional help-seeking behaviour, (c) highlighting the demands for new health care services. The related seven sub-themes included being disappointed with current hospital services; distrusting services provided by community health centres, private institutes and commercial online platforms; preferring not seeking help from professionals as their first choice; hesitating to express their inner discourse to professionals; following confinement requirement and family burden prevents mothers from seeking professional help; experiencing urgent needs for new baby-care-related services; and determining the importance of mothers' needs. The necessity of professional support in the first month after childbirth was strongly emphasized by the participants. Online professional guidance and support were perceived as the best way to receive services in this study. CONCLUSION: The results of this descriptive phenomenological study suggested that the current maternal and child health care services were insufficient and could not meet primiparous mothers' need. The results also indicated that identifying barriers and providing services focused on mothers' needs may be an effective strategy to enhance primiparous mothers' well-being, and further suggested that feasibility, convenience, and the cultural adaptability of health care services should be considered during the delivery of postpartum interventions.

Psychosocial interventions on perinatal depression in China: A systematic review and meta-analysis.

BACKGROUND: The prevalence of perinatal depression is 16.3% in China and has shown a rising trend in the last decade. However, few studies summarized psychosocial interventions for perinatal depression in this country. This study aimed at evaluating and characterizing psychosocial interventions for perinatal depression in Mainland China. METHODS: Ten major English and Chinese language electronic bibliographic databases were searched for RCTs examining the effect of psychosocial interventions for perinatal depressed women in Mainland China. Studies meeting eligibility criteria and published before 25th February 2019 were included, while those focusing on a very specific sub-population or reporting non-psychosocial interventions were excluded. Data was extracted by a standard form. Meta-analysis was conducted to obtain a summary measure of the effectiveness of the interventions in reducing perinatal depressive symptoms. The theoretical underpinnings and implementation processes of the interventions were also characterised. RESULTS: A total of 6857 articles were identified in the initial database searching, of which, 26 studies were eligible for data analysis, representing a sample size of 4673. Meta-analysis indicated that psychosocial interventions in China significantly reduced perinatal depressive symptoms (standard difference in means 0.81, 95% confidence intervals -1.03 to -0.58, P < 0.001). However, the overall evidence presented substantial heterogeneity (I2 = 91.12%). Most interventions were implemented in hospitals in urban areas by non-specialist health care providers. Few studies reported details of implementation procedures or scale-up strategies. LIMITATIONS: The evidence in this review is of moderate to low quality and therefore, should be interpreted with caution. Some of the trials were inadequately powered and tended to overestimate effect sizes. CONCLUSIONS: Current psychosocial interventions in China are somewhat effective in reducing perinatal depressive symptoms. High quality RCTs on scale-up interventions are required, especially in rural areas.

Making therapies culturally relevant: translation, cultural adaptation and field-testing of the Thinking Healthy Programme for perinatal depression in China.

BACKGROUND: The prevalence of perinatal depression in China ranges from 15 to 20% and the vast majority of prenatally depressed women do not receive the intervention they require. Recent research evidence shows that evidence based, culturally-adapted psychosocial interventions are effective in reducing mental health problems. The World Health Organization (WHO) has endorsed the Thinking Healthy Programme (THP), which is an evidence based psychosocial intervention that can be delivered by non-mental health specialists. The aim of this study was to translate and adapt THP for the Chinese population and to establish its acceptability when delivered by non-specialists to a group of mothers with perinatal depression. METHODS: The study was conducted in two phases. The THP manual, handbook, and health calendar was translated and adapted based on 8 domains of the Bernal framework (language, metaphors, content, concepts, goals, context, people and methods). Pre-testing was done using cognitive interviewing in the first phase. In second phase of field-testing, THP sessions were delivered to the depressed women by local THP trained nurses. Post intervention, programme survey was used for evaluation. RESULTS: This study showed that the core structure, process and techniques of the THP were culturally compatible with the target Chinese population and did not require major changes. It was found that the adapted version of THP manual, handbook, and health calendar were acceptable, understandable, and culturally relevant to the Chinese women and their family members. Nurses were found as a suitable delivery agent by the mothers and their families. CONCLUSION: The Thinking Healthy Programme is acceptable and transferable to the Chinese cultural and healthcare context and nurses are a suitable delivery agent. The translated and adapted version of THP can be used for further implementation and evaluation studies in the Chinese context. Further evaluation can help establish the effectiveness of the programme and barriers to scale-up in China.

Measuring the implementation strength of a perinatal mental health intervention delivered by peer volunteers in rural Pakistan.

The South Asian region, including Pakistan, reports one of the highest rates of perinatal depression. Effective task-shifting perinatal mental health interventions exist and are gaining attention of policy makers, as a potential solution to bridge the existing treatment gap. However, no specific indicators are available to gauge the level of implementation for such interventions in the South Asian region. The Thinking Healthy Programme Peer-delivered (THPP) is a perinatal mental health intervention delivered, at scale, by peer volunteers (PVs). An effectiveness trial for THPP based on 570 depressed pregnant women was conducted in rural Rawalpindi, Pakistan. In addition, we also examined the implementation processes of THPP in order to develop an index to gauge implementation strength of this intervention. The key components of this index are based on four important intervention processes related to service provision which include; i) the competence of PVs, ii) supervisions attended by PVs and iii) number and iv) duration of THPP sessions. We attempt to inform an implementation strength index which best correlates with reduced perinatal depression and disability at 6 months post childbirth. Knowledge of such an implementation strength index for a task-shifted perinatal depression intervention carries implications for scale up strategies.

Delivering maternal mental health through peer volunteers: a 5-year report.

BACKGROUND: Maternal depression affects one in five women in low-and middle income countries (LMIC) and has significant economic and social impacts. Evidence-based psychosocial interventions delivered by non-specialist health workers are recommended as first-line management of the condition, and recent studies on such interventions from LMIC show promising results. However, lack of human resource to deliver the interventions is a major bottle-neck to scale-up, and much research attention has been devoted to 'task-sharing' initiatives. A peer-delivered version of the World Health Organization's Thinking Healthy Programme for perinatal depression in Pakistan and India showed clinical, functional and social benefits to women at 3 months postpartum. The programme has been iteratively adapted and continually delivered for 5 years in Pakistan. In this report, we describe the extended intervention and factors contributing to the peers' continued motivation and retention, and suggest future directions to address scale-up challenges. METHODS: The study was conducted in rural Rawalpindi. We used mixed methods to evaluate the programme 5 years since its initiation. The competency of the peers in delivering the intervention was evaluated using a specially developed Quality and Competency Checklist, an observational tool used by trainers to rate a group session on key areas of competencies. In-depth interviews explored factors contributing to the peer volunteers' continued motivation and retention, as well as the key challenges faced. RESULTS: Our key findings are that about 70% of the peer volunteers inducted 5 years ago continued to be part of the programme, retaining their competency in delivering the intervention, with only token financial incentives. Factors contributing to sustained motivation included altruistic aspirations, enhanced social standing in the community, personal benefits to their own mental health, and the possibility for other avenues of employment. Long-term challenges included demotivation due to lack of certainty about the programme's future, increased requirement for financial incentivisation, the logistics of organising groups in the community, and resistance from some families to the need for ongoing care. CONCLUSIONS: The programme, given the sustained motivation and competence of peer volunteers in delivering the intervention, has the potential for long-term sustainability in under-resourced settings and a candidate for scale-up.

Using technology to scale-up training and supervision of community health workers in the psychosocial management of perinatal depression: a non-inferiority, randomized controlled trial.

BACKGROUND: The Thinking Healthy Programme (THP) is an evidence-based psychological intervention endorsed by the World Health Organization, tailored for non-specialist health workers in low- and middle-income countries. However, training and supervision of large numbers of health workers is a major challenge for the scale-up of THP. We developed a 'Technology-Assisted Cascaded Training and Supervision system' (TACTS) for THP consisting of a training application and cascaded supervision delivered from a distance. METHODS: A single-blind, non-inferiority, randomized controlled trial was conducted in District Swat, a post-conflict area of North Pakistan. Eighty community health workers (called Lady Health Workers or LHWs) were randomly assigned to either TACTS or conventional face-to-face training and supervision by a specialist. Competence of LHWs in delivering THP post-training was assessed by independent observers rating a therapeutic session using a standardized measure, the 'Enhancing Assessment of Common Therapeutic factors' (ENACT), immediately post-training and after 3 months. ENACT uses a Likert scale to score an observed interaction on 18 dimensions, with a total score of 54, and a higher score indicating greater competence. RESULTS: Results indicated no significant differences between health workers trained using TACTS and supervised from distance v. those trained and supervised by a specialist face-to-face (mean ENACT score M  =  24.97, s.d.  =  5.95 v. M =  27.27, s.d.  =  5.60, p  =  0.079, 95% CI 4.87-0.27) and at 3 months follow-up assessment (M  =  44.48, s.d.  =  3.97 v. M =  43.63, s.d.  =  6.34, p  =  0.53, CI -1.88 to 3.59). CONCLUSIONS: TACTS can provide a promising tool for training and supervision of front-line workers in areas where there is a shortage of specialist trainers and supervisors.

Effectiveness of a brief group psychological intervention for women in a post-conflict setting in Pakistan: a single-blind, cluster, randomised controlled trial.

BACKGROUND: Many women are affected by anxiety and depression after armed conflict in low-income and middle-income countries, yet few scalable options for their mental health care exist. We aimed to establish the effectiveness of a brief group psychological intervention for women in a conflict-affected setting in rural Swat, Pakistan. METHODS: In a single-blind, cluster, randomised, controlled trial, 34 community clusters in two union councils of rural Swat, Pakistan, were randomised using block permutation at a 1:1 ratio to intervention (group intervention with five sessions incorporating behavioural strategies facilitated by non-specialists) or control (enhanced usual care) groups. Researchers responsible for identifying participants, obtaining consent, enrolment, and outcome assessments were masked to allocation. A community cluster was defined as neighbourhood of about 150 households covered by a lady health worker. Women aged 18-60 years who provided written informed consent, resided in the participating cluster catchment areas, scored at least 3 on the General Health Questionnaire-12, and at least 17 on the WHO Disability Assessment Schedule were recruited. The primary outcome, combined anxiety and depression symptoms, was measured 3 months after the intervention with the Hospital Anxiety and Depression Scale (HADS). Modified intention-to-treat analyses were done using mixed models adjusted for covariates and clusters defined a priori. The trial is registered with the Australian New Zealand Clinical Trials Registry, number 12616000037404, and is now closed to new participants. FINDINGS: From 34 eligible community clusters, 306 women in the intervention group and 306 women in the enhanced usual care (EUC) group were enrolled between Jan 11, 2016, and Aug 21, 2016, and the results of 288 (94%) of 306 women in the intervention group and 290 (95%) of 306 women in the EUC group were included in the primary endpoint analysis. At 3 months, women in the intervention group had significantly lower mean total scores on the HADS than women in the control group (10·01 [SD 7·54] vs 14·75 [8·11]; adjusted mean difference [AMD] -4·53, 95% CI -7·13 to -1·92; p=0·0007). Individual HADS anxiety scores were also significantly lower in the intervention group than in the control group (5·43 [SD 4·18] vs 8·02 [4·69]; AMD -2·52, 95% CI -4·04 to -1·01), as were depression scores (4·59 [3·87] vs 6·73 [3·91]; AMD -2·04, -3·19 to -0·88). No adverse events were reported in either group. INTERPRETATION: Our group psychological intervention resulted in clinically significant reductions in anxiety and depressive symptoms at 3 months, and might be a feasible and effective option for women with psychological distress in rural post-conflict settings. FUNDING: WHO through a grant from the Office for Foreign Disaster Assistance.

Delivering the Thinking Healthy Programme for perinatal depression through volunteer peers: a cluster randomised controlled trial in Pakistan.

BACKGROUND: The Thinking Healthy Programme (THP), which is endorsed by WHO, is an evidence-based intervention for perinatal depression. We adapted THP for delivery by volunteer peers (laywomen from the community) to address the human resource needs in bridging the treatment gap, and we aimed to assess its effectiveness and cost-effectiveness in Rawalpindi, Pakistan. METHODS: In this cluster randomised controlled trial, we randomly assigned 40 village clusters (1:1) to provide either THP peer-delivered (THPP) and enhanced usual care (EUC; intervention group) or EUC only (control group) to the participants within clusters. These villages were randomly selected from eligible villages by an independent researcher. The participants were pregnant women aged 18 years or older who had scored at least 10 on the Patient Health Questionnaire-9 (PHQ-9), who we recruited from households within communities in Rawalpindi, Pakistan. The research teams who were responsible for recruiting trial participants were masked to treatment allocations. Participants attended follow-up visits at 3 and 6 months after childbirth. 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 was registered with ClinicalTrials.gov, number NCT02111915. FINDINGS: Between April 15 and July 30, 2014, we randomly selected 40 of 46 eligible village clusters for assessment, as per sample size calculations. Between Oct 15, 2014, and Feb 25, 2016, we identified and screened 971 women from 20 village clusters that had been randomly assigned to the THPP and EUC group and 939 women from 20 village clusters that had been randomly assigned to the EUC only group. In the intervention group, 79 women were ineligible for inclusion, 11 women refused screening, 597 women screened negative on the PHQ-9, and one woman did not consent to participate. In the control group, 75 women were ineligible for inclusion, 14 women refused screening, 562 women screened negative on the PHQ-9, and one woman did not consent to participate. We enrolled 283 (29%) women in the intervention group and 287 (31%) women in the control group. At 6 months after childbirth, 227 (80%) women in the THPP and EUC group and 226 (79%) women in the EUC only group were assessed for the primary outcome. The severity of depression (assessed by PHQ-9 scores; standardised mean difference -0·13, 95% CI -0·31 to 0·06; p=0·07) and prevalence of remission (49% in the intervention group vs 45% in the control group; prevalence ratio 1·12, 95% CI 0·95 to 1·29; p=0·14) did not significantly differ between the groups 6 months after childbirth. There was no evidence of significant differences in serious adverse events between the groups. INTERPRETATION: THPP had no effect on symptom severity or remission from perinatal depression at 6 months after childbirth, but we found that it was beneficial on some other metrics of severity and disability and that it was cost-effective. THPP could be a step towards use of an unused human resource to address the treatment gap in perinatal depression. FUNDING: National Institute of Mental Health (USA).

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).

"Someone like us": delivering maternal mental health through peers in two South Asian contexts.

BACKGROUND: Peer-led psychosocial interventions are one solution to address the great paucity of skilled mental health human resources in South Asia. The aim of this study was to explore peer-delivered care for maternal depression in two diverse contexts in South Asia. METHODS: The study was carried out in the urban setting of Goa, India and rural setting in Rawalpindi, Pakistan. In total, 61 in-depth interviews (IDIs) and 3 focus group discussions (FGDs), and 38 IDIs and 10 FGDs, were conducted with multiple stakeholders in urban Goa and rural Rawalpindi respectively. We used the framework approach to analyze data. RESULTS: Peers from the same community were the most preferred delivery agents of a community-based psychosocial intervention in both sites. There were contextual similarities and differences between the two sites. Preferred characteristics among peers included local, middle-aged, educated mothers with similar experiences to participants, good communication skills and a good character. Key differences between the two contexts included a greater emphasis on the peer׳s family social standing in rural Rawalpindi and financial incentives as motivators for individual peers in urban Goa. LIMITATIONS: Generalizability of our findings is limited to two specific contexts in a vast and diverse region. DISCUSSION: Our study demonstrates that peers have the potential to deliver maternal psychosocial interventions in low-income settings. There are contextual differences in the preferred characteristics and motivators between the sites, and these should be carefully considered in program implementation.