An examination of the relationship between risk perceptions, cultural-religious beliefs and coping during COVID-19 pandemic control in South Asian countries: a systematic review.

BACKGROUND: Covid 19 was declared as a public health emergency by the World Health Organisation (WHO) due to its rapid spread and catastrophic effects on health. It affected around 119 M people with mortality rate of 0.27% worldwide, including South-Asians. This review aims to understand the risk perceptions, cultural religious beliefs and the coping mechanisms of South Asians during the Covid 19 pandemic. METHODS: We conducted a systematic review following the Preferred Reporting Items for Systematic Reviews and Meta-Analyses (PRISMA) guidelines. The following search engines were used: Medline, Cochrane Library, PsycINFO, CINAHL, and Web of Science. Included studies investigated perceptions and opinions of individuals on knowledge, risk and protective factors, native faith based practices, and attitudes towards the COVID-19 pandemic. RESULTS: The database search produced 282 articles to screen. The final narrative synthesis included five studies comprising of 13,476 participants from Pakistan, India, Nepal, and Bangladesh. Ten studies, comprising 7,893 participants, were eligible and included for meta-analysis. The overall pooled prevalence with maximum heterogeneity for correct knowledge of symptoms, hand washing or use of sanitizers, face masking use of herbal or traditional remedies and physical distancing or avoidance of contact was reported through meta-analysis. CONCLUSION: The review brings forth a useful comparison of individual and cultural differences in KAP, risk perceptions and coping strategies. This review highlights the need for and importance of tailored information dissemination, culturally sensitive risk communication, targeted educational interventions, community engagement and empowerment, policy, and infrastructure improvements, as well as continued research and data collection. By addressing these implications, efforts to mitigate the impact of COVID-19 can be more effective and equitable across diverse populations. PROSPERO REGISTRATION: CRD42021246475.

A feasibility randomized controlled trial of culturally adapted Getting Better Bite-by-Bite (Ca-GBBB) intervention for individuals with eating disorders in Pakistan.

BACKGROUND: Eating disorders (EDs) are serious mental health conditions that affect a person physically and psychologically. In the past, EDs were only recognized as a cultural phenomenon/societal by-product of the West. However, research evidence marks its presence in non-western countries also, including South Asia. This study aims to evaluate the feasibility and acceptability of a manualized psychological intervention called Getting Better Bite by Bite (GBBB) in individuals who screened positive on measures of EDs in Pakistan. METHODS: The proposed study is a feasibility randomized controlled trial (fRCT). The study will be conducted at five sites across Pakistan: Karachi, Hyderabad, Lahore, Rawalpindi, and Multan to recruit a total of 80 participants. Eligible participants will be randomized to either (1) the intervention group; in which they will receive one-to-one sessions of GBBB along with routine care or (2) the routine care group; in which they will only have access to the routine care. We have received ethics approval by the National Bioethics Committee. The study is registered at clinicaltrials.gov (NCT05724394). The study team has received permission from recruitment centers: hospitals (i.e. the psychiatry department of public and private hospitals based in these cities), fitness centers (i.e., gyms), educational institutes (i.e., colleges and universities), and community settings (i.e. community health clinics). Self-referrals from General Practitioners and community settings will be accepted. The intervention manual has been translated into Urdu and a multidisciplinary team including service users has culturally adapted the content of intervention for local context. DISCUSSION: This study will provide evidence on feasibility and acceptability of a culturally adapted intervention for individuals who screen positive on measures of EDs. The findings of this study will inform a fully powered Randomized Controlled Trial of the proposed intervention. TRIAL REGISTRATION: The study is registered on clinicaltrials.gov (NCT05724394). Protocol version (1.0. 1st June 2022).

Assessing the efficacy of a brief universal family skills programme on child behaviour and family functioning in Gilgit-Baltistan, Pakistan: protocol for a feasibility randomised controlled trial of the Strong Families programme.

PURPOSE: The global burden of mental health difficulties among children underscores the importance of early prevention. This study aims to assess the efficacy, feasibility and acceptability of the Strong Families programme in enhancing child behaviour and family functioning in low-resource settings in Gilgit-Baltistan, Pakistan. METHODS AND ANALYSIS: This is a two-arm, multisite feasibility randomised controlled trial with an embedded process evaluation in three districts of Gilgit-Baltistan, namely Gilgit, Hunza and Skardu. 90 families living in these challenged settings, comprising a female primary caregiver aged 18 or above, and at least one child aged 8-15 years, will participate. Participants will be randomly assigned to either receive the Strong Families programme or to the waitlist group. Strong Families is a 7-hour family skills group intervention programme attended by children and their primary caregivers over 3 weeks. The waitlist group will be offered the intervention after their outcome assessment. Three raters will conduct blind assessments at baseline, 2 and 6 weeks postintervention. The primary outcome measures include the feasibility of Strong Families, as determined by families' recruitment and attendance rates, and programme completeness (mean number of sessions attended, attrition rates). The secondary outcomes include assessment of child behaviour, parenting practices, parental adjustment and child resilience. Purposefully selected participants, including up to five caregivers from each site, researchers and facilitators delivering the intervention, will be interviewed. Descriptive statistics will be used to analyse primary and secondary outcomes. The process evaluation will be conducted in terms of programme context, reach, fidelity, dose delivered and received, implementation, and recruitment. ETHICS AND DISSEMINATION: This study has been approved by the UNODC Drug Prevention and Health Branch in the Headquarters office of Vienna and the National Bioethics Committee of Pakistan. Findings will be disseminated through publication in reputable journals, newsletters and presentations at conferences. TRIAL REGISTRATION NUMBER: NCT05933850.

Effectiveness of Learning through Play Plus (LTP Plus) Parenting Intervention on Behaviours of Young Children of Depressed Mothers: A Randomised Controlled Trial.

Evidence has shown that parenting intervention programmes improve parental knowledge, attitudes, and practices, which helps in promoting child development. This study aims to examine the effectiveness of parenting intervention in improving child behaviours. This is a secondary analysis of data from a cluster-randomised controlled trial with depressed mothers aged 18-44 years with a child aged 0 to 36 months. This paper reports findings from the dataset of participants with a child aged between 24 and 36 months. Villages (n = 120) were randomised into either of two arms: learning through play plus (LTP Plus) or treatment as usual (TAU). LTP Plus is a 10-session, group parenting intervention integrated with cognitive behaviour therapy, delivered over 3 months. This secondary analysis reports findings on the Eyberg Child Behaviour Inventory (ECBI) and the Home Observation for Measurement of the Environment (HOME). Findings show a significant improvement in child behaviour (ECBI) scores (p < 0.011) and HOME scores (p < 0.001) in the intervention group compared to TAU at 3-month follow-up. In a low-resource setting, low-cost group parenting intervention delivered by community health workers has the potential to improve child behaviours and quality of the home environment. Parenting interventions aimed at improving child behavioural problems can have significant implications for the child, family, and broader societal outcomes. Addressing behavioural problems in early years, parenting interventions can potentially reduce long-term consequences and costs associated with untreated child behavioural issues.

Lived experiences of mothers with postnatal anxiety: a qualitative phenomenology study from Pakistan.

OBJECTIVE: The prevalence of postnatal anxiety is high among women during the first year of childbirth globally. Rates are higher in low and middle-income countries (LMICs), that is, 24%. Existing literature on maternal mood and its impact on child development has largely focused on postnatal depression. Postnatal anxiety has been recognised to have significant independent effects similar to those of postnatal depression, including negative effects on various aspects of maternal well-being including quality of life, parent-child interaction and child development. The evidence exploring lived experiences of postnatal anxiety is limited from LMICs. This study explored the lived experiences of anxiety in postnatal mothers in Pakistan. DESIGN: A phenomenological approach was used for this qualitative study. The audio-recorded interviews were transcribed and analysed using the process of thematic analysis. SETTINGS: The study was conducted in two community settings in Karachi, Pakistan; the Bin Qasim and Gadap town. PARTICIPANTS: Women who were 18 years of age or older, had a live childbirth within the previous 12 months and had a score of 10 or higher on the Generalised Anxiety Disorder-7. RESULTS: In-depth, one-to-one interviews were conducted with 10 participants. The qualitative data comprised of three themes. Theme one: Factors perceived to be associated with postnatal anxiety, Theme two: The perceived impact of postnatal anxiety and Theme three: Support needs. The first theme was further subdivided into two subthemes, that is, Mothers' perception of navigating domestic responsibilities and sociocultural norms of motherhood and financial constraints. CONCLUSION: Despite the high prevalence of postnatal anxiety in LMICs there is not any published evidence on exploring this phenomenon through in-depth research in Pakistan. Understanding the lived experiences will help health professionals to identify women at risk of developing postnatal anxiety and to develop effective culturally appropriate interventions for women with anxiety during this postnatal period.

Economic costs of perinatal depression and anxiety in a lower middle income country: Pakistan.

BACKGROUND: Women's mental health during the perinatal period is a major public health problem in Pakistan. Many challenges and competing priorities prevent progress to address the large treatment gap. Aim To quantify the long-term impacts of untreated perinatal depression and anxiety in economic terms, thus highlighting its overall burden based on country-specific evidence. METHODS: Cost estimates were generated for a hypothetical cohort of women giving birth in 2017, and their children. Women and children experiencing adverse events linked to perinatal mental health problems were modelled over 40 years. Costs assigned to adverse events included were those linked to losses in quantity and quality-of-life, productivity, and healthcare-related expenditure. Present values were derived using a discount rate of 3 %. Data were taken from published cohort studies, as well as from sources of population, economic and health indicators. RESULTS: The total costs were $16.5 billion for the cohort and $2680 per woman giving birth. The by far largest proportion referred to quality-of-life losses ($15.8 billion). Productivity losses and out-of-pocket expenditure made up only a small proportion of the costs, due to low wages and market prices. When the costs of maternal suicide were included, total costs increased to $16.6 billion. LIMITATIONS: Important evidence gaps prevented the inclusion of all cost consequences linked to perinatal mental health problems. CONCLUSIONS: Total national costs are much higher compared with those in other, higher middle-income countries, reflecting the excessive disease burden. This study is an important first step to inform resource allocations.

Antecedents, clinical and psychological characteristics of a large sample of individuals who have self-harmed recruited from primary care and hospital settings in Pakistan.

BACKGROUND: Suicide is one of the leading causes of mortality worldwide, and the majority of suicide deaths occur in low- and middle-income countries. AIMS: To evaluate the demographic and clinical characteristics of individuals who have presented to health services following self-harm in Pakistan. METHOD: This study is a cross-sectional baseline analysis of participants from a large multicentre randomised controlled trial of self-harm prevention in Pakistan. A total of 901 participants with a history of self-harm were recruited from primary care clinics, emergency departments and general hospitals in five major cities in Pakistan. The Beck Scale for Suicide Ideation (BSI), Beck Depression Inventory (BDI), Beck Hopelessness Scale (BHS) and Suicide Attempt Self Injury Interview assessment scales were completed. RESULTS: Most participants recruited were females (n = 544, 60.4%) in their 20s. Compared with males, females had lower educational attainment and higher unemployment rates and reported higher severity scores on BSI, BDI and BHS. Interpersonal conflict was the most frequently cited antecedent to self-harm, followed by financial difficulties in both community and hospital settings. Suicide was the most frequently reported motive of self-harm (N = 776, 86.1%). Suicidal intent was proportionally higher in community-presenting patients (community: N = 318, 96.9% v. hospital: N = 458, 79.9%; P < 0.001). The most frequently reported methods of self-harm were ingestion of pesticides and toxic chemicals. CONCLUSIONS: Young females are the dominant demographic group in this population and are more likely to attend community settings to seek help. Suicidal intent as the motivator of self-harm and use of potentially lethal methods may suggest that this population is at high risk of suicide.

Psychosocial and pharmacological interventions for personality disorders in low- and middle-income countries: A systematic review.

Personality disorders (PDs) have a global prevalence of 7.8% and are associated with increased rates of morbidity and mortality. Most research on PDs has been conducted in High Income Countries (HICs). We conducted a systematic review to investigate the effectiveness of psychosocial and pharmacological interventions for personality disorders (PDs) in individuals from Low- and Middle-Income Countries (LMICs.) We systematically searched MEDLINE, Embase, APA PsycInfo, Web of Science, Cumulative Index of Nursing and Allied Health Literature (CINAHL), and The Cochrane Library from inception to January 5, 2023. Inclusion criteria were quantitative studies and grey literature where participants received a psychosocial or pharmacological intervention for PD. Exclusion criteria were qualitative studies, review articles, studies in which PD was not the primary condition, and articles not available in English. The Cochrane Risk of Bias tool version 2.0 and Joanna Briggs Institute instruments were used to measure risk of bias. Studies were pooled by type of study, PD investigated, type of intervention, assessment methods, and outcomes. Sixteen studies met inclusion criteria and were included. Fifteen were intervention studies related to borderline PD. Only one studied mixed PDs. Twelve studies were of psychotherapy, one pharmacotherapy, one combination of both, and two neurostimulation. Most of the studies showed improvement in symptoms though data was largely collected using self-report measures. There were only six RCTs. There is a dearth of literature on interventions for PDs in LMICs and funding bodies should prioritize research in LMICs. Systematic Review Registration Number: PROSPERO CRD42021233415.

Prevalence of suicidal ideation and suicide attempts in individuals with psychosis and bipolar disorder in South Asia: systematic review and meta-analysis.

BACKGROUND: Suicidal ideation and attempts are growing public health concerns globally. Evidence from high-income countries suggests that individuals with psychosis and bipolar disorder are at increased risk of suicidal ideation and attempts, but there is a scarcity of evidence from South Asia. AIMS: To estimate the prevalence of suicidal ideation and attempts in individuals with psychosis and bipolar disorder in South Asia. METHOD: In this systematic review and meta-analysis, four databases (PsycINFO, Web of Science, EMBASE and Medline) were searched until December 2022. Pooled prevalence was estimated with random-effects models. Heterogeneity was quantified with the I2-statistic. RESULTS: The pooled sample size across the 21 studies was 3745 participants, 1941 (51.8%) of which were male. The pooled prevalence of suicide attempts in South Asian people with either psychosis or bipolar disorder was 22% (95% CI 17-27; n = 15). The pooled prevalence of suicidal ideation with psychosis or bipolar disorder combined was 38% (95% CI 27-51; n = 10). Meta-regression, subgroup and sensitivity analysis showed that the pooled prevalence estimates for both suicide attempt and ideation remained unaffected by variations in critical appraisal ratings and study designs. Only one study reported data on suicide-related deaths. CONCLUSIONS: One in four individuals diagnosed with psychosis or bipolar disorder have reported suicide attempts, whereas up to one in three have experienced suicidal ideation. These findings underscore the urgent need for clinicians to regularly assess and monitor suicidal ideation and attempts among individuals with these disorders in South Asia.

Is equipoise a useful concept to justify randomised controlled trials in the cultural context of Pakistan? A survey of clinicians in relation to a trial of talking therapy for young people who self-harm.

BACKGROUND: Clinical equipoise, also defined as the uncertainty principle, is considered essential when recruiting subjects to a clinical trial. However, equipoise is threatened when clinicians are influenced by their own preferences. Little research has investigated equipoise in the context of trial recruitment. METHODS: This cross-sectional survey sought clinicians' views (operationalised as 11 statements relating to treatments offered in a trial of a psychological intervention for young people) about equipoise and individual treatment preferences in the context of moral justification for recruiting young people at risk of self-harm or suicide to a randomised controlled trial (RCT) to evaluate the Youth Culturally Adapted Manual Assisted Psychological Intervention (Y-CMAP) in Pakistan. We compared the views of clinicians involved in Y-CMAP RCT recruitment to those of a sample of clinicians not involved in trial recruitment but treating similar patients, comparing their sociodemographic characteristics and the proportions of those in each group agreeing with each statement. RESULTS: There was a response rate of 96% (75/78). Findings showed that, during trial recruitment and before the RCT results were known, the majority of all responding clinicians (73.3%) considered Y-CMAP to be an effective treatment for young people at risk of self-harm or suicide. Although there was an acknowledgement of individual preferences for the intervention, there was near consensus (90%) on the need to conduct an RCT for reaching an evidence-based decision. However, there were no significant differences in the proportion of recruiting clinicians reporting a treatment preference for Y-CMAP than non-recruiting clinicians (31 (88.6%) versus 36 (90%), p = 0.566). A significantly higher proportion of non-recruiting clinicians (87.5%) as compared to (48.5%) in the trial (p = 0.000) stated that there may be other treatments that may be equally good for the patients, seemingly undermining a preference for the intervention. Those reporting a treatment preference also acknowledged that there was nothing on which this preference was based, however confident they felt about them, thus accepting clinical equipoise as ethical justification for conducting the RCT. There was a significant group difference in views that treatment overall is better as a result of young patients' participation in the Y-CMAP trial (p = 0.015) (i.e. more clinicians not involved in the trial agreed with this statement). Similarly, more clinicians not involved in the trial agreed on the perceived availability of other treatment options that were good for young people at risk of self-harm (p < 0.05). CONCLUSIONS: The paper highlights that clinicians in Pakistan accept the notion of clinical equipoise as an ethical justification for patient participation in RCTs. The need for conducting RCTs to generate evidence base and to reduce bias was considered important by the clinical community.

Exploratory RCT of a group psychological intervention for postnatal depression in British mothers of South Asian origin - ROSHNI-D.

BACKGROUND: Postnatal depression (PND) is a global public health problem. There is a high prevalence of PND amongst ethnic minority women and major ethnic inequalities in mental health care in the U.K. Language and cultural barriers pose a significant challenge for access to timely treatment and interventions for British South Asian (BSA) women with PND. METHODS: The study, carried out in Manchester and Lancashire, England, was a two-arm single-blind exploratory randomised controlled trial. BSA women (N = 83) having a baby <12 months were randomised either to the group receiving the culturally adapted Positive Health Programme (PHP) (n = 42) or to the group receiving treatment as usual (TAU) (n = 41). Follow-up assessments were at 3 months (end of intervention) and 6 months after randomisation. RESULTS: Using an intention to treat analysis, there was no significant difference between PHP intervention and TAU groups in depression measured using Hamilton Depression Rating Scale both at 3 and 6 months follow up. Using modified intention to treat analysis, women who attended four or more sessions showed significant reduction in depression in the PHP group compared to the TAU group and the greater number of sessions attended was associated with greater reductions in depression scores. LIMITATIONS: The sample was relatively small and the study was conducted in one geographical area in Northwest England; hence, these results may not be generalizable to other regions and populations. CONCLUSION: The recruitment and trial retention figures highlighted the ability of the research team to engage with BSA women, having implications in planning services for this group. TRIAL REGISTRATION: Clinicaltrials.govNCT01838889.

Integrated Moving on After Breast Cancer and Culturally Adapted Cognitive Behavior Therapy intervention for depression and anxiety among Pakistani women with breast cancer: Protocol of a randomized controlled trial.

Objective: The diagnosis and treatment of breast cancer is associated with significant distress that has huge impact on survivors' quality of life. The objective of this study is to assess the effectiveness of an integrated intervention "Moving on After Breast Cancer (ABC) Plus culturally adapted Cognitive Behavior Therapy" (Moving on ABC Plus). Method: This is a randomized controlled trial that aims to recruit 354 breast cancer survivors from the inpatient and outpatient oncology departments in public and private hospitals in Karachi, Hyderabad, Lahore, Multan, and Rawalpindi in Pakistan. Patients scoring 10 or above on either the Patient Health Questionnaire-9 and/or the Generalized Anxiety Disorder scale (GAD-7) will be recruited. Baseline assessments will include Functional Assessment of Cancer Therapy-Breast; EuroQol-5D; Multidimensional Scale for Perceived Social Support; Intrusive Thoughts Scale; and Rosenberg Self-Esteem Scale. Participants randomized into intervention arm, Moving on ABC Plus, will receive 12 individual therapy sessions over 4 months. Follow-up will be completed at 4- and 6-month post-randomization, using all baseline instruments along with the Client Satisfaction Questionnaire (CSQ-8). We will also explore the participants', their family members', and the therapists' experiences of the trial and intervention. Results: We will be assessing the effectiveness of intervention in reducing depression and anxiety in breast cancer survivors as a primary outcome of the trial. The secondary outcomes will include effectiveness of intervention in terms of reduction in intrusive thoughts and improvement in health-related quality of life, self-esteem, and perceived social support. Conclusion: The results of the study will inform the design of a future larger randomized control trial with long-term follow-up.

A culturally adapted manual-assisted problem-solving intervention (CMAP) for adults with a history of self-harm: a multi-centre randomised controlled trial.

BACKGROUND: Self-harm is an important predictor of a suicide death. Culturally appropriate strategies for the prevention of self-harm and suicide are needed but the evidence is very limited from low- and middle-income countries (LMICs). This study aims to investigate the effectiveness of a culturally adapted manual-assisted problem-solving intervention (CMAP) for patients presenting after self-harm. METHODS: This was a rater-blind, multicenter randomised controlled trial. The study sites were all participating emergency departments, medical wards of general hospitals and primary care centres in Karachi, Lahore, Rawalpindi, Peshawar, and Quetta, Pakistan. Patients presenting after a self-harm episode (n = 901) to participating recruitment sites were assessed and randomised (1:1) to one of the two arms; CMAP with enhanced treatment as usual (E-TAU) or E-TAU. The intervention (CMAP) is a manual-assisted, cognitive behaviour therapy (CBT)-informed problem-focused therapy, comprising six one-to-one sessions delivered over three months. Repetition of self-harm at 12-month post-randomisation was the primary outcome and secondary outcomes included suicidal ideation, hopelessness, depression, health-related quality of life (QoL), coping resources, and level of satisfaction with service received, assessed at baseline, 3-, 6-, 9-, and 12-month post-randomisation. The trial is registered on ClinicalTrials.gov. NCT02742922 (April 2016). RESULTS: We screened 3786 patients for eligibility and 901 eligible, consented patients were randomly assigned to the CMAP plus E-TAU arm (n = 440) and E-TAU arm (N = 461). The number of self-harm repetitions for CMAP plus E-TAU was lower (n = 17) compared to the E-TAU arm (n = 23) at 12-month post-randomisation, but the difference was not statistically significant (p = 0.407). There was a statistically and clinically significant reduction in other outcomes including suicidal ideation (- 3.6 (- 4.9, - 2.4)), depression (- 7.1 (- 8.7, - 5.4)), hopelessness (- 2.6 (- 3.4, - 1.8), and improvement in health-related QoL and coping resources after completion of the intervention in the CMAP plus E-TAU arm compared to the E-TAU arm. The effect was sustained at 12-month follow-up for all the outcomes except for suicidal ideation and hopelessness. On suicidal ideation and hopelessness, participants in the intervention arm scored lower compared to the E-TAU arm but the difference was not statistically significant, though the participants in both arms were in low-risk category at 12-month follow-up. The improvement in both arms is explained by the established role of enhanced care in suicide prevention. CONCLUSIONS: Suicidal ideation is considered an important target for the prevention of suicide, therefore, CMAP intervention should be considered for inclusion in the self-harm and suicide prevention guidelines. Given the improvement in the E-TAU arm, the potential use of brief interventions such as regular contact requires further exploration.

Supporting Depressed Mothers of Young Children with Intellectual Disability: Feasibility of an Integrated Parenting Intervention in a Low-Income Setting.

As a lifelong condition, intellectual disability (ID) remains a public health priority. Parents caring for children with ID experience serious challenges to their wellbeing, including depression, anxiety, stress and health-related quality of life. Integrated parenting interventions, which have been well evidenced for depressed mothers, may also effectively support depressed parents with a child with ID in low-resource settings such as Pakistan, and in turn optimise child outcomes. We conducted a mixed-method rater-blind feasibility randomised controlled trial, which assessed the feasibility and acceptability of the Learning Through Play in My Own Way Plus (LTP-IMOW Plus) intervention. Mothers who screened positive for depression (n = 26) with a young child (age 3-6 years) with ID were recruited from two low-resource community settings. Participants in the intervention arm (n = 13) received 12 group sessions of LTP-IMOW Plus and others (n = 13) received routine care. The intervention was feasible and acceptable with 100% retention and 100% session attendance. The intervention improved depression, anxiety, parenting stress and child socialisation score outcomes relative to the routine care arm. The framework utilised to analyse the qualitative interviews with seven participants at pre-intervention identified a range of struggles experienced by the mothers, and at post-intervention, found improved knowledge of child development and practices, improved mother-child relationships, recommendations for the intervention and perceived practical barriers and facilitators. The findings highlight the prospects for a clinical and cost-effective trial of an integrated parenting intervention to manage long-term parental mental health needs and improve child outcomes.

Clinicians', patients' and carers' perspectives on borderline personality disorder in Pakistan: A mixed methods study protocol.

Borderline Personality Disorder (BPD) is a condition characterised by significant social and occupational impairment and high rates of suicide. In high income countries, mental health professionals carry negative attitudes towards patients with BPD, find it difficult to work with patients with BPD, and even avoid seeing these patients. Negative attitudes and stigma can cause patients to fear mistreatment by health care providers and create additional barriers to care. Patients' self-stigma and illness understanding BPD also affects treatment engagement and outcomes; better knowledge about mental illness predicts intentions to seek care. The perspectives of mental health clinicians and patients on BPD have not been researched in the Pakistani setting and likely differ from other settings due to economic, cultural, and health care system differences. Our study aims to understand the attitudes of mental health clinicians towards patients with BPD in Pakistan using a self-report survey. We also aim to explore explanatory models of illness in individuals with BPD and their family members/carers using a Short Explanatory Model Interview (SEMI). The results of this study are important as we know attitudes and illness understanding greatly impact care. Results of this study will help guide BPD-specific training for mental health clinicians who care for patients with BPD and help inform approaches to interventions for patients with BPD in Pakistan.

Effect of Adjunctive Simvastatin on Depressive Symptoms Among Adults With Treatment-Resistant Depression: A Randomized Clinical Trial.

Importance: Immune-metabolic disturbances have been implicated in the pathophysiology of major depressive disorder and may be more prominent in individuals with treatment-resistant depression (TRD). Preliminary trials suggest that lipid-lowering agents, including statins, may be useful adjunctive treatments for major depressive disorder. However, no adequately powered clinical trials have assessed the antidepressant efficacy of these agents in TRD. Objective: To assess the efficacy and tolerability of adjunctive simvastatin compared with placebo for reduction of depressive symptoms in TRD. Design, Setting, and Participants: This 12-week, double-blind, placebo-controlled randomized clinical trial was conducted in 5 centers in Pakistan. The study involved adults (aged 18-75 years) with a Diagnostic and Statistical Manual of Mental Disorders (Fifth Edition) major depressive episode that had failed to respond to at least 2 adequate trials of antidepressants. Participants were enrolled between March 1, 2019, and February 28, 2021; statistical analysis was performed from February 1 to June 15, 2022, using mixed models. Intervention: Participants were randomized to receive standard care plus 20 mg/d of simvastatin or placebo. Main Outcomes and Measures: The primary outcome was the difference between the 2 groups in change in Montgomery-Åsberg Depression Rating Scale total scores at week 12. Secondary outcomes included changes in scores on the 24-item Hamilton Rating Scale for Depression, the Clinical Global Impression scale, and the 7-item Generalized Anxiety Disorder scale and change in body mass index from baseline to week 12. C-reactive protein and plasma lipids were measured at baseline and week 12. Results: A total of 150 participants were randomized to simvastatin (n = 77; median [IQR] age, 40 [30-45] years; 43 [56%] female) or placebo (n = 73; median [IQR] age, 35 [31-41] years; 40 [55%] female). A significant baseline to end point reduction in Montgomery-Åsberg Depression Rating Scale total score was observed in both groups and did not differ significantly between groups (estimated mean difference for simvastatin vs placebo, -0.61; 95% CI, -3.69 to 2.46; P = .70). Similarly, there were no significant group differences in any of the secondary outcomes or evidence for differences in adverse effects between groups. A planned secondary analysis indicated that changes in plasma C-reactive protein and lipids from baseline to end point did not mediate response to simvastatin. Conclusions and Relevance: In this randomized clinical trial, simvastatin provided no additional therapeutic benefit for depressive symptoms in TRD compared with standard care. Trial Registration: ClinicalTrials.gov Identifier: NCT03435744.

Culturally adapted psychoeducation for bipolar disorder in a low-resource setting: protocol for a multicentre randomised controlled trial.

BACKGROUND: Bipolar disorder is a source of marked disability, morbidity and premature death. There is a paucity of research on personalised psychosocial interventions for bipolar disorder, especially in low-resource settings. A pilot randomised controlled trial (RCT) of a culturally adapted psychoeducation intervention for bipolar disorder (CaPE) in Pakistan reported higher patient satisfaction, enhanced medication adherence, knowledge and attitudes regarding bipolar disorder, and improvement in mood symptom scores and health-related quality of life measures compared with treatment as usual (TAU). AIMS: The current protocol describes a larger multicentre RCT to confirm the clinical and cost-effectiveness of CaPE in Pakistan. Trial registration: NCT05223959. METHOD: A multicentre individual, parallel-arm RCT of CaPE in 300 Pakistani adults with bipolar disorder. Participants over the age of 18, with a diagnosis of bipolar I or II disorder who are currently euthymic, will be recruited from seven sites: Karachi, Lahore, Multan, Rawalpindi, Peshawar, Hyderabad and Quetta. Time to recurrence will be the primary outcome assessed using the Longitudinal Interval Follow-up Evaluation (LIFE). Secondary measures will include mood symptoms, quality of life and functioning, adherence to psychotropic medications, and knowledge and attitudes regarding bipolar disorder. RESULTS: This trial will assess the effectiveness of the CaPE intervention compared with TAU in reducing the time to recurrence for people with bipolar disorder currently in remission in Pakistan and determine the effect on clinical outcomes, quality of life and functioning. CONCLUSIONS: A successful trial might lead to rapid implementation of CaPE in clinical practice, not only in Pakistan, but also in other low-resource settings, including those in high-income countries, to improve clinical outcomes, social and occupational functioning, and quality of life in South Asian and other minority group patients with bipolar disorder.

Youth Culturally adapted Manual Assisted Problem Solving Training (YCMAP) in Pakistani adolescent with a history of self-harm: protocol for multicentre clinical and cost-effectiveness randomised controlled trial.

INTRODUCTION: Suicide is a global health concern. Sociocultural factors have an impact on self-harm and suicide rates. In Pakistan, both self-harm and suicide are considered as criminal offence's and are condemned on both religious and social grounds. The proposed intervention 'Youth Culturally Adapted Manual Assisted Problem Solving Training (YCMAP)' is based on principles of problem-solving and cognitive-behavioural therapy. YCMAP is a brief, culturally relevant, scalable intervention that can be implemented in routine clinical practice if found to be effective. METHOD AND ANALYSIS: A multicentre rater blind randomised controlled trial to evaluate the clinical and cost-effectiveness of YCMAP including a sample of 652 participants, aged 12-18 years, presenting to general physicians/clinicians, emergency room after self harm or self referrals. We will test the effectiveness of 8-10 individual sessions of YCMAP delivered over 3 months compared with treatment as usual. Primary outcome measure is repetition of self-harm at 12 months. The seconday outcomes include reduction in suicidal ideation, hopelessness and distress and improvement in health related quality of life. Assessments will be completed at baseline, 3, 6, 9 and 12 months postrandomisation. The nested qualitative component will explore perceptions about management of self-harm and suicide prevention among adolescents and investigate participants' experiences with YCMAP. The study will be guided by the theory of change approach to ensure that the whole trial is centred around needs of the end beneficiaries as key stakeholders in the process. ETHICS AND DISSEMINATION: Ethics approval has been obtained from the Ethics Committee of University of Manchester, the National Bioethics Committee in Pakistan. The findings of this study will be disseminated through community workshops, social media, conference presentations and peer-reviewed journals. TRIAL REGISTRATION NUMBER: NCT04131179.

Building Resilience Against ViolencE (BRAVE): protocol of a parenting intervention for mothers and fathers with post-traumatic stress disorder in Pakistan.

Background: Prevalence of post-traumatic stress disorder (PTSD) is high in Pakistan both due to natural disasters and ongoing conflicts. Offspring of trauma survivors are at increased risk for mental and physical illnesses. Parental PTSD has been linked to troubled parent-child relationships, behaviour problems, trauma symptoms, and depression in children. This study aims to explore the acceptability, feasibility and indications of the effectiveness of group learning through play plus trauma-focused cognitive behaviour therapy (LTP Plus TF-CBT) for parents experiencing PTSD. Methods/Design: This is a two-arm pilot cluster randomised controlled trial (RCT). We aim to recruit 300 parents with a diagnosis of PTSD. The screening will be done using the Impact of Event Scale-Revised. Diagnosis of PTSD will be confirmed using the Clinician-Administered PTSD Scale-5 (CAPS-5). Union Councils from Peshawar and Karachi will be randomised into either group LTP Plus TF CBT arm or treatment as usual (TAU). The intervention includes 12 sessions of LTP Plus TF-CBT delivered weekly in the first 2 months and then fortnightly in a group setting by trained psychologists. The groups will be co-facilitated by the community health workers (CHWs). Parents will be assessed at baseline and 4th month (end of the intervention), using the Patient Health Questionnaire (PHQ-9), Generalised Anxiety Disorder (GAD-7) Scale, Client Service Receipt Inventory (CSRI), and Ages and Stages Questionnaire (ASQ-3). Discussion: This trial would help build an understanding of the acceptability, feasibility and indications of the effectiveness of a low-cost parenting intervention.