Development and initial evaluation of a clinical prediction model for risk of treatment resistance in first-episode psychosis: Schizophrenia Prediction of Resistance to Treatment (SPIRIT).

BACKGROUND: A clinical tool to estimate the risk of treatment-resistant schizophrenia (TRS) in people with first-episode psychosis (FEP) would inform early detection of TRS and overcome the delay of up to 5 years in starting TRS medication. AIMS: To develop and evaluate a model that could predict the risk of TRS in routine clinical practice. METHOD: We used data from two UK-based FEP cohorts (GAP and AESOP-10) to develop and internally validate a prognostic model that supports identification of patients at high-risk of TRS soon after FEP diagnosis. Using sociodemographic and clinical predictors, a model for predicting risk of TRS was developed based on penalised logistic regression, with missing data handled using multiple imputation. Internal validation was undertaken via bootstrapping, obtaining optimism-adjusted estimates of the model's performance. Interviews and focus groups with clinicians were conducted to establish clinically relevant risk thresholds and understand the acceptability and perceived utility of the model. RESULTS: We included seven factors in the prediction model that are predominantly assessed in clinical practice in patients with FEP. The model predicted treatment resistance among the 1081 patients with reasonable accuracy; the model's C-statistic was 0.727 (95% CI 0.723-0.732) prior to shrinkage and 0.687 after adjustment for optimism. Calibration was good (expected/observed ratio: 0.999; calibration-in-the-large: 0.000584) after adjustment for optimism. CONCLUSIONS: We developed and internally validated a prediction model with reasonably good predictive metrics. Clinicians, patients and carers were involved in the development process. External validation of the tool is needed followed by co-design methodology to support implementation in early intervention services.

Academic psychiatry is everyone's business.

This editorial considers the value and nature of academic psychiatry by asking what defines the specialty and psychiatrists as academics. We frame academic psychiatry as a way of thinking that benefits clinical services and discuss how to inspire the next generation of academics.

Defining the Role of the Fire and Rescue Service in Mental Health Support for Older Adults: A Qualitative Study.

INTRODUCTION: Anxiety and depression in older adults (60+ years of age) are under-diagnosed and under-treated. Older adults are less likely to seek help for these problems due to a lack of awareness, difficulty accessing health care due to availability or disability and fear of loss of independence. Existing points of contact between older adults and non-traditional services, for example, the Fire and Rescue Service (FRS), could provide opportunities to support help-seeking for mental ill-health. The FRS conduct Home Fire Safety Visits (HFSVs) with older adults and are well positioned to provide health-related support. This study examines a range of perspectives on the potential role of the FRS in the identification of, and signposting for, anxiety and depression in older adults. METHODS: This was a qualitative study carried out using mixed methods in West Midlands, UK. Semi-structured interviews were conducted with older adults and health and social care providers (practitioners, managers, commissioners) to explore the acceptability of the FRS expanding its role to detect and signpost for anxiety and depression in older adults. Observations examined delivery of existing HFSVs to older adults. Data were combined and analysed using a reflexive thematic approach. RESULTS: Eighteen health and social care providers and 8 older adults were interviewed; 10 HFSVs were observed. Two overarching themes were identified: (1) Potential role for the FRS and (2) Operationalising identification of mental health problems by FRS. Interviews and observations demonstrated how HFSVs offer a suitable opportunity to start conversations about mental health. All interview participants felt that although the FRS would be well placed to deliver an intervention, they would require training, support and a referral pathway co-produced with and supported by health and social care partners. CONCLUSION: A whole-system approach is needed if the FRS are to expand HFSVs to identify mental health problems in older adults and provide signposting to appropriate services. PATIENT OR PUBLIC CONTRIBUTION: J.S. is a public co-investigator. A Patient Advisory Group contributed to the initial funding application, design and conduct of the study, including data analysis and advice on dissemination.

The relationship between pain and depression and anxiety in patients with inflammatory arthritis: a systematic review protocol.

Pain is a major challenge for patients with inflammatory arthritis (IA). Depression and anxiety are common comorbidities in IA, associating with worse outcomes. How they relate to pain is uncertain, with existing systematic reviews (a) mainly considering cross-sectional studies, (b) focusing on the relationship between pain and mental health in the context of disease activity/quality of life, and (c) not specifically considering the impact of treating depression/anxiety on pain. This PROSPERO-registered (CRD42023411823) systematic review will address this knowledge-gap by synthesizing evidence to summarise the associations (and potential mediators) between pain and depression/anxiety and evaluate the impact of treating co-morbid depression/anxiety on pain in IA. Relevant databases will be searched, articles screened and their quality appraised (using Joanna Briggs Institute critical appraisal tools) by two reviewers. Eligible studies will include adults with rheumatoid arthritis or spondyloarthritis, be a clinical trial or observational study, and either (a) report the relationship between pain and depression/anxiety (observational studies/baseline trials), or (b) randomise participants to a pharmacological or psychological treatment to manage depression/anxiety with a pain outcome as an endpoint (trials). To synthesise data on the association between pain and depression/anxiety, where available adjusted coefficients from regression models will be pooled in a random-effects meta-analysis. A synthesis without meta-analysis will summarise mediators. To evaluate the impact of treating depression/anxiety on pain, endpoint mean differences between treatment arms will be combined in a random-effects meta-analysis. Through understanding how depression/anxiety contribute to pain in IA, our review has the potential to help optimise approaches to IA pain.

Association of Anemia with Parathyroid Hormone Levels and Other Factors in Patients with End-Stage Renal Disease Undergoing Hemodialysis: A Cross-Sectional, Real-World Data Study in Pakistan.

End-stage renal disease (ESRD) patients are mostly managed with maintenance hemodialysis (MHD). ESRD patients on MHD also present with many complications, such as anemia, hyperparathyroidism, and hepatitis prevalence. This study depicts the real-world scenario of anemia among MHD and end-stage renal disease patients in the Pakistani population. A retrospective, multicentric, and real-world data analytical study was conducted at 4 dialysis centers in Pakistan. The study had a sample size of n = 342 patients on maintenance hemodialysis. The data were gathered from the medical records of patients. Data analysis was performed using STATA Version 16. Statistical significance was gauged at a 0.05 level of significance. According to our results, the mean age of the patients was 45 (±15) years. Most of the patients were male (n = 234, 68.4%), whereas 58.1% of the patients were maintained on twice-weekly hemodialysis. The most commonly reported comorbidities were hypertension and diabetes mellitus. The frequency of dialysis (P < 0.01) and comorbidities (P = 0.009) had a significant association with anemia in MHD patients. The majority of the patients had hyperparathyroidism (52%) with anemia. Upon performing binary logistic regression, multivariate analysis displayed a similar odds value for having anemia in patients with every additional month in the duration of hemodialysis (OR 1.01, P = 0.001), the odds of anemic patients having a positive antihepatitis-C antibody (OR 2.22, P = 0.013), and the odds of having anemia in patients in the age category below 45 years (OR 1.93, P = 0.013). In conclusion, the study results depict that every additional month in the duration of hemodialysis, age (<45 years), and positive anti-HCV antibody status, these variables were more likely to have anemia in our study MHD patients. While in our final multivariate model, no statistically significant association was observed between hyperparathyroidism and anemia.

Role of Primary Care Physicians in management of Schizophrenia in Low and Middle Income Countries (LMIC): A systematic review.

Many people with Schizophrenia lack the resources and access to mental health services especially in low and middle income countries. Integration of mental health into primary care services can be a cost effective way of reducing the disability associated with Schizophrenia. Our aim was to review the studies conducted on role of Primary care physicians in management of Schizophrenia in low and middle income countries. PRISMA guidelines were followed and we registered the study protocol at PROSPERO. Four Electronic Databases (Medline, Psycinfo, CINAHL and Embase) were searched in May 2022. Relevant articles after search were 504 of which 61 full text were examined. A total of 20 studies were included in the final review comprising of observational, experimental and qualitative studies. Most studies reported on abilities of Primary care physicians including their knowledge, perceptions, skills and competencies in identifying and management of Schizophrenia and related Psychosis. Findings suggest that there is considerable amount of stigma, lack of awareness and social support about people diagnosed with Schizophrenia. Significant improvement was observed in diagnosis and management of schizophrenia by Primary care physicians who received appropriate training by experts in the field. This review suggests that appropriate training of General practitioners in diagnosing and treating schizophrenia can help in reduction of huge Treatment Gap in Schizophrenia. They can also be utilised in delivering psycho social interventions to improve overall quality of patient care.

Impact of COVID-19 on mental health research: is this the breaking point?

There are many structural problems facing the UK at present, from a weakened National Health Service to deeply ingrained inequality. These challenges extend through society to clinical practice and have an impact on current mental health research, which was in a perilous state even before the coronavirus pandemic hit. In this editorial, a group of psychiatric researchers who currently sit on the Academic Faculty of the Royal College of Psychiatrists and represent the breadth of research in mental health from across the UK discuss the challenges faced in academic mental health research. They reflect on the need for additional investment in the specialty and ask whether this is a turning point for the future of mental health research.

An International Adult Guideline for Making Clozapine Titration Safer by Using Six Ancestry-Based Personalized Dosing Titrations, CRP, and Clozapine Levels.

This international guideline proposes improving clozapine package inserts worldwide by using ancestry-based dosing and titration. Adverse drug reaction (ADR) databases suggest that clozapine is the third most toxic drug in the United States (US), and it produces four times higher worldwide pneumonia mortality than that by agranulocytosis or myocarditis. For trough steady-state clozapine serum concentrations, the therapeutic reference range is narrow, from 350 to 600 ng/mL with the potential for toxicity and ADRs as concentrations increase. Clozapine is mainly metabolized by CYP1A2 (female non-smokers, the lowest dose; male smokers, the highest dose). Poor metabolizer status through phenotypic conversion is associated with co-prescription of inhibitors (including oral contraceptives and valproate), obesity, or inflammation with C-reactive protein (CRP) elevations. The Asian population (Pakistan to Japan) or the Americas' original inhabitants have lower CYP1A2 activity and require lower clozapine doses to reach concentrations of 350 ng/mL. In the US, daily doses of 300-600 mg/day are recommended. Slow personalized titration may prevent early ADRs (including syncope, myocarditis, and pneumonia). This guideline defines six personalized titration schedules for inpatients: 1) ancestry from Asia or the original people from the Americas with lower metabolism (obesity or valproate) needing minimum therapeutic dosages of 75-150 mg/day, 2) ancestry from Asia or the original people from the Americas with average metabolism needing 175-300 mg/day, 3) European/Western Asian ancestry with lower metabolism (obesity or valproate) needing 100-200 mg/day, 4) European/Western Asian ancestry with average metabolism needing 250-400 mg/day, 5) in the US with ancestries other than from Asia or the original people from the Americas with lower clozapine metabolism (obesity or valproate) needing 150-300 mg/day, and 6) in the US with ancestries other than from Asia or the original people from the Americas with average clozapine metabolism needing 300-600 mg/day. Baseline and weekly CRP monitoring for at least four weeks is required to identify any inflammation, including inflammation secondary to clozapine rapid titration.

Culturally adapted trauma-focused CBT-based guided self-help (CatCBT GSH) for female victims of domestic violence in Pakistan: feasibility randomized controlled trial.

BACKGROUND: Cognitive behaviour therapy (CBT), self-help and guided self-help interventions have been found to be efficacious and cost effective for victims of trauma, but there are limited data from low- and middle-income countries on culturally adapted interventions for trauma. AIMS: To investigate the feasibility and acceptability of culturally adapted trauma-focused CBT-based guided self-help (CatCBT GSH) for female victims of domestic violence in Pakistan. METHOD: This randomized controlled trial (RCT) recruited 50 participants from shelter homes in Karachi and randomized them to two equal groups. The intervention group received GSH in nine sessions over 12 weeks. The control group was a waitlist control. The primary outcomes were feasibility and acceptability. Secondary outcomes included Impact of Event Scale-Revised (IES-R), Hospital Anxiety and Depression Scale (HADS) and the WHO Disability Assessment Schedule 2 (WHO DAS 2). Assessments were carried out at baseline and at 12 weeks. RESULTS: Out of 60 clients who met DSM-5 criteria for post-traumatic stress disorder (PTSD), 56 (93.3%) agreed to participate in the study. Retention to the intervention group was excellent, with 92% (23/25) attending more than six sessions. Statistically significant differences were noted post-intervention in secondary outcomes in favour of the intervention. CONCLUSIONS: A trial of CatCBT GSH was feasible and the intervention was acceptable to Pakistani women who had experienced domestic violence. Furthermore, it may be helpful in improving symptoms of PTSD, depression, anxiety and overall functioning in this population. The results provide a rationale for a larger, confirmatory RCT of CatCBT GSH.

Pharmacological or non-pharmacological interventions for treatment of common mental disorders associated with Tuberculosis: A systematic review.

We aimed to review the literature on interventions for treating Common Mental Disorders (CMD) in people with Tuberculosis (TB). We followed PRISMA guidelines and the protocol was registered at PROSPERO. The electronic databases (PsycInfo, CINAHL, Medline, Google Scholar, Embase) were searched from 1982 to 2020. 349 relevant records were screened, with 26 examined at full text. 13 studies were included totalling 4326 participants. A meta-analysis was not possible due to nature of data, thus descriptive synthesis was conducted. Eleven studies evaluated psychosocial interventions, which significantly improved adherence or cure rates from TB, anxiety and depression. The elements of effective psychosocial interventions included; combating stigma, socioeconomic disadvantage, managing associated guilt and fear of contagion, and explanatory models of illness in local population. Two articles evaluated pharmacological interventions (antidepressants and Vitamin D). This is the first systematic review of interventions to treat CMD in TB. The studies were mostly low quality and mental health outcomes were not adequately described. However, this review suggests that it is feasible to develop and test interventions for improving mental health outcomes and enhancing treatment adherence in TB.

Cost-effectiveness of WHO Problem Management Plus for adults with mood and anxiety disorders in a post-conflict area of Pakistan: randomised controlled trial.

BACKGROUND: With the development of evidence-based interventions for treatment of priority mental health conditions in humanitarian settings, it is important to establish the cost-effectiveness of such interventions to enable their scale-up. AIMS: To evaluate the cost-effectiveness of the Problem Management Plus (PM+) intervention compared with enhanced usual care (EUC) for common mental disorders in primary healthcare in Peshawar, Pakistan. Trial registration ACTRN12614001235695 (anzctr.org.au). METHOD: We randomly allocated 346 participants to either PM+ (n = 172) or EUC (n = 174). Effectiveness was measured using the Hospital Anxiety and Depression Scale (HADS) at 3 months post-intervention. Cost-effectiveness analysis was performed as incremental costs (measured in Pakistani rupees, PKR) per unit change in anxiety, depression and functioning scores. RESULTS: The total cost of delivering PM+ per participant was estimated at PKR 16 967 (US$163.14) using an international trainer and supervisor, and PKR 3645 (US$35.04) employing a local trainer. The mean cost per unit score improvement in anxiety and depression symptoms on the HADS was PKR 2957 (95% CI 2262-4029) (US$28) with an international trainer/supervisor and PKR 588 (95% CI 434-820) (US$6) with a local trainer/supervisor. The mean incremental cost-effectiveness ratio (ICER) to successfully treat a case of depression (PHQ-9 ≥ 10) using an international supervisor was PKR 53 770 (95% CI 39 394-77 399) (US$517), compared with PKR 10 705 (95% CI 7731-15 627) (US$102.93) using a local supervisor. CONCLUSIONS: The PM+ intervention was more effective but also more costly than EUC in reducing symptoms of anxiety, depression and improving functioning in adults impaired by psychological distress in a post-conflict setting of Pakistan.

Scarlett Letter: A study based on experience of stigma by COVID-19 patients in quarantine.

BACKGROUND AND OBJECTIVES: Stigma around COVID-19 is a major barrier in global efforts to control the COVID 19 pandemic. Limited data is available regarding stigma faced by COVID-19 patients in low- and middle-income countries (LMIC). The aim of the current study was to explore the stigma experienced by hospitalized patients with COVID-19 illness in Lahore, Pakistan. METHODS: Following Institutional Review Board approval and informed consent, patients were assessed using modified HIV short form stigma scale and open-ended questions. Questions focused on experiences, feelings, and opinions as to how patients feel and how they were treated prior to and during the hospitalization. Data analysis for quantitative data was performed using SPSS-20, while qualitative responses were interpreted by content analysis method. RESULTS: One hundred and fourteen patients were interviewed (Mean age 38.8 years + 15.3) with 53.5% being males. Widespread experience of stigma was reported by patients particularly for concerns about public attitudes (7.43 + 1.43) & disclosure (6.89 + 1.45). Main themes which emerged from the qualitative responses were social stigma and rejection, humiliating behaviour of others, breach of confidentiality, loss of trust/ respect, and impact of COVID-19 diagnosis on their business. CONCLUSIONS: Existence of significant stigma among COVID-19 patients isolated in a tertiary care hospital in a LMIC highlights the need for culturally sensitive strategies to address it.

Patterns of symptoms before a diagnosis of first episode psychosis: a latent class analysis of UK primary care electronic health records.

BACKGROUND: The nature of symptoms in the prodromal period of first episode psychosis (FEP) remains unclear. The objective was to determine the patterns of symptoms recorded in primary care in the 5 years before FEP diagnosis. METHODS: The study was set within 568 practices contributing to a UK primary care health record database (Clinical Practice Research Datalink). Patients aged 16-45 years with a first coded record of FEP, and no antipsychotic prescription more than 1 year prior to FEP diagnosis (n = 3045) was age, gender, and practice matched to controls without FEP (n = 12,180). Fifty-five symptoms recorded in primary care in the previous 5 years, categorised into 8 groups (mood-related, 'neurotic', behavioural change, volition change, cognitive change, perceptual problem, substance misuse, physical symptoms), were compared between cases and controls. Common patterns of symptoms prior to FEP diagnosis were identified using latent class analysis. RESULTS: Median age at diagnosis was 30 years, 63% were male. Non-affective psychosis (67%) was the most common diagnosis. Mood-related, 'neurotic', and physical symptoms were frequently recorded (> 30% of patients) before diagnosis, and behavioural change, volition change, and substance misuse were also common (> 10%). Prevalence of all symptom groups was higher in FEP patients than in controls (adjusted odds ratios 1.33-112). Median time from the first recorded symptom to FEP diagnosis was 2-2.5 years except for perceptual problem (70 days). The optimal latent class model applied to FEP patients determined three distinct patient clusters: 'no or minimal symptom cluster' (49%) had no or few symptoms recorded; 'affective symptom cluster' (40%) mainly had mood-related and 'neurotic' symptoms; and 'multiple symptom cluster' (11%) consulted for three or more symptom groups before diagnosis. The multiple symptom cluster was more likely to have drug-induced psychosis, female, obese, and have a higher morbidity burden. Affective and multiple symptom clusters showed a good discriminative ability (C-statistic 0.766; sensitivity 51.2% and specificity 86.7%) for FEP, and many patients in these clusters had consulted for their symptoms several years before FEP diagnosis. CONCLUSIONS: Distinctive patterns of prodromal symptoms may help alert general practitioners to those developing psychosis, facilitating earlier identification and referral to specialist care, thereby avoiding potentially detrimental treatment delay.

Correction to: Problem management plus (PM+) for common mental disorders in a humanitarian setting in Pakistan; study protocol for a randomised controlled trial (RCT).

Following publication of the original article [1], the first author reported an error in referring his paper.

Different communication strategies for disclosing a diagnosis of schizophrenia and related disorders.

BACKGROUND: Delivering the diagnosis of a serious illness is an important skill in most fields of medicine, including mental health. Research has found that communication skills can impact on a person's recall and understanding of the diagnosis, treatment options and prognosis. People may feel confused and perplexed when information about their illness is not communicated properly. Sharing information about diagnosis of a serious mental illness is particularly challenging. The nature of mental illness is often difficult to explain since there may be no clear aetiology, and the treatment options and prognosis may vary enormously. In addition, newly diagnosed psychiatric patients, who are actively ill, often may not accept their diagnosis due to lack of insight or stigma attached to the condition. There are several interventions that aim to help clinicians to communicate life changing medical diagnoses to people; however, little is known specifically for delivering a diagnosis of schizophrenia. OBJECTIVES: To evaluate evidence from randomised controlled trials (RCTs) for the efficacy of different communication strategies used by clinicians to inform people about the diagnosis and outcome of schizophrenia compared with treatment as usual and to compare efficacy between different communication strategies. SEARCH METHODS: On 22 June 2015 and 29 June 2016, we searched the Cochrane Schizophrenia Group's Study-Based Register of Trials. We also searched sources of grey literature (e.g., dissertations, theses, clinical reports, evaluations published on websites, clinical guidelines and reports from regulatory agencies). SELECTION CRITERIA: We planned to include all relevant RCTs that included adults with schizophrenia or related disorders, including schizophreniform disorder, schizoaffective disorder and delusional disorder. The trials would have investigated the effects of communication strategy or strategies that helped clinicians deliver information specifically about a diagnosis of schizophrenia (which can also include communication regarding the treatment options available and prognosis). DATA COLLECTION AND ANALYSIS: Review authors independently examined all reports from the searches for any relevant studies. We planned to extract data independently. For binary outcomes, we would have calculated risk ratio (RR) and its 95% confidence interval (CI), on an intention-to-treat basis. For continuous data, we would have estimated the mean difference (MD) between groups and its 95% CI. We would have employed a random-effects model for analyses. We planned to assess risk of bias for included studies. We created a 'Summary of findings' table using GRADE. MAIN RESULTS: The searches identified 44 records which appeared to be relevant to the aims of the review. We obtained full reports for seven potential studies; however, after close inspection none of these studies met the inclusion criteria. AUTHORS' CONCLUSIONS: Good communication of diagnosis can affect treatment planning, compliance and patient outcomes, especially in the case of conditions such as schizophrenia, which has the potential to cause serious life disruption for both people with schizophrenia and their carers. Currently, there is no evidence based on findings from RCTs assessing the effects of communication strategies for disclosing the diagnosis of schizophrenia and related disorders. Research is required.

Development of fixed dose combination tablets of aripiprazole plus divalproex sodium and their simultaneous determination using HPLC-UV.

A vast majority of psychiatric patients are effectively treated with combination of drugs to improve efficacy and adherence, but due to limited research and development in fixed dose combination (FDC) in psychiatry, these products are not commonly available. The aim of this study is to prepare cost effective FDC tablets containing aripiprazole and divalproex sodium. Two batches of fixed dose combination tablets, FDC1 and FDC2, were successfully prepared using wet granulation technique. Furthermore, aripiprazole tablets A1 and A2 and divalproex tablets D1 were also formulated as reference to compare the in vitro availability profile. An accurate and simple isocratic HPLC method was established and validated for the simultaneous quantification of aripiprazole and valproic acid in the FDC tablets. A reversed-phase C18 (250 × 4.6 mm) column in isocratic mode was used. The mobile phase consisted of acetonitrile and 0.32% KH2PO4 (60:40, v/v), flow rate was set at 1.0 mL/min and the detection was performed at 210 nm. Average percent recoveries of aripiprazole and valproic acid were 96.0 and 95.5%, respectively, meeting the official requirements. The newly developed FDC product may be used for the better therapeutic outcomes of combined use of aripiprazole and valproic acid, which may improve patient adherence.

Effect of a Multicomponent Behavioral Intervention in Adults Impaired by Psychological Distress in a Conflict-Affected Area of Pakistan: A Randomized Clinical Trial.

Importance: The mental health consequences of conflict and violence are wide-ranging and pervasive. Scalable interventions to address a range of mental health problems are needed. Objective: To test the effectiveness of a multicomponent behavioral intervention delivered by lay health workers to adults with psychological distress in primary care settings. Design, Setting, and Participants: A randomized clinical trial was conducted from November 1, 2014, through January 28, 2016, in 3 primary care centers in Peshawar, Pakistan, that included 346 adult primary care attendees with high levels of both psychological distress and functional impairment according to the 12-item General Health Questionnaire and the World Health Organization Disability Assessment Schedule 2.0 (WHODAS 2.0). Interventions: Lay health workers administered 5 weekly 90-minute individual sessions that included empirically supported strategies of problem solving, behavioral activation, strengthening social support, and stress management. The control was enhanced usual care. Main Outcomes and Measures: Primary outcomes, anxiety and depression symptoms, were independently measured at 3 months with the Hospital Anxiety and Depression Scale (HADS). Secondary outcomes were posttraumatic stress symptoms (Posttraumatic Stress Disorder Checklist for DSM-5), functional impairment (WHODAS 2.0), progress on problems for which the person sought help (Psychological Outcome Profiles), and symptoms of depressive disorder (9-item Patient Health Questionnaire). Results: Among 346 patients (mean [SD] age, 33.0 [11.8] years; 78.9% women), 172 were randomly assigned to the intervention and 174 to enhanced usual care; among them, 146 and 160 completed the study, respectively. At baseline, the intervention and control groups had similar mean (SD) HADS scores on symptoms of anxiety (14.16 [3.17] vs 13.64 [3.20]; adjusted mean difference [AMD], 0.52; 95% CI, -0.22 to 1.27) and depression (12.67 [3.27] vs 12.49 [3.34]; AMD, 0.17, 95% CI, -0.54 to 0.89). After 3 months of treatment, the intervention group had significantly lower mean (SD) HADS scores than the control group for anxiety (7.25 [3.63] vs 10.03 [3.87]; AMD, -2.77; 95% CI, -3.56 to -1.98) and depression (6.30 [3.40] vs 9.27 [3.56]; AMD, -2.98; 95% CI, -3.74 to -2.22). At 3 months, there were also significant differences in scores of posttraumatic stress (AMD, -5.86; 95% CI, -8.53 to -3.19), functional impairment (AMD, -4.17; 95% CI, -5.84 to -2.51), problems for which the person sought help (AMD, -1.58; 95% CI, -2.40 to -0.77), and symptoms of depressive disorder (AMD, -3.41; 95% CI, -4.49 to -2.34). Conclusions and Relevance: Among adults impaired by psychological distress in a conflict-affected area, lay health worker administration of a brief multicomponent intervention based on established behavioral strategies, compared with enhanced usual care, resulted in clinically significant reductions in anxiety and depressive symptoms at 3 months. Trial Registration: anzctr.org.au Identifier: ANZCTR12614001235695.

A Qualitative Study to Explore Patients', Carers' and Health Professionals' Views to Culturally Adapt CBT for Psychosis (CBTp) in Pakistan.

BACKGROUND: Cognitive Behaviour Therapy (CBT) has an established evidence base and is recommended by the national organizations in United Kingdom and the United States. CBT remains under utilized in low and middle income countries. CBT was developed in the west and it has been suggested that it is underpinned by western values. It therefore follows that to make CBT accessible for non western clients, it needs adapting into a given culture. AIMS: Our aim was to develop guidelines for adapting CBT for psychosis in Pakistan by incorporating the views of the patients, their carers and mental health professionals. METHOD: We conducted a series of qualitative studies in Pakistan to adapt CBT for psychosis (a total of 92 interviews). The data were analyzed by systematic content and question analysis. Analysis started by identifying emerging themes and categories. Themes emerging from the analyses of interviews by each interviewer were compared and contrasted with others interviewers constantly. Triangulation of themes and concepts was undertaken to further compare and contrast the data from the different participating groups. RESULTS: The results of these studies highlighted the barriers in therapy as well as strengths while working with this patient group. Patients and their carers in Pakistan use a bio-psycho-spiritual-social model of illness. They seek help from various sources. Therapists make minor adjustments in therapy. CONCLUSIONS: The findings from this study will help therapists working with this client group using CBT for psychosis in Pakistan. These results need to be tested through controlled trials.

Problem Management Plus (PM+) for common mental disorders in a humanitarian setting in Pakistan; study protocol for a randomised controlled trial (RCT).

BACKGROUND: In humanitarian settings common mental disorders (depression, anxiety disorders, posttraumatic stress disorder) are highly prevalent. The World Health Organization (WHO) has developed Problem Management Plus (PM+), a 5-session, individual psychological intervention program, delivered by paraprofessionals that addresses common mental disorders in people in communities affected by adversity. The objectives of this study are to test effectiveness and cost-effectiveness of the locally adapted PM+ compared to Treatment as usual (TAU) in Peshawar District, Pakistan. METHODS: A randomised controlled trial will be conducted in 346 primary care attendees in 3 health care centres in Peshawar District, Pakistan. After informed consent, primary care attendees with high levels of psychological distress according to the General Health Questionnaire-12 (GHQ-12) and functional impairment (WHO Disability Assessment Schedule 2.0 (WHODAS)) will be assigned to PM+ (n = 173) or TAU (n = 173). At baseline, 1 week and 3 months following PM+, independent assessors will assess psychological distress with the Hospital Anxiety and Depression Scale (HADS), and functional disability with the WHODAS. Secondary outcomes are posttraumatic stress disorder (PTSD) symptoms, and client-perceived priority problems. Further, cost-effectiveness will be assessed using the Service Receipt Inventory (SRI). DISCUSSION: If proven effective, PM+ will be rolled out to other areas for further adaptation and testing in diverse humanitarian settings. TRIAL REGISTRATION: ACTRN12614001235695. Registered 26 November 2014. Australian New Zealand Clinical Trials Registry.