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.

Patients' and healthcare professionals' perspectives on a community-based intervention for schizophrenia in Pakistan: A focus group study.

OBJECTIVE: To explore the perceptions and experiences of schizophrenia from patients, their care givers, health care providers, spiritual and traditional healers to develop a community-based intervention for improving treatment adherence for people with schizophrenia in Pakistan. METHODS: This qualitative study involved four focus group discussions (FGD) with a total of 26 participants: patients and carers (n = 5), primary care staff (n = 7), medical technicians (n = 8) and traditional and spiritual healers (n = 6). The participants were selected using purposive sampling method. FGDs were audio-recorded and transcribed. A thematic analysis was applied to the data set. RESULTS: The themes identified were (i) Schizophrenia is not merely a biomedical problem: participants believed that poverty and an inferiority complex resulting from social disparity caused schizophrenia and contributed to non-adherence to medications; (ii) Spiritual healing goes hand in hand with the medical treatment: participants regarded spiritual and traditional treatment methods as an inherent part of schizophrenia patients' well-being and rehabilitation; (iii) Services for mental illness: mental health is not covered under primary health in a basic health unit: participants believed that the lack of services, training and necessary medication in primary care are major issues for treating schizophrenia in community; (iv) Barriers to community-based interventions: primary care staff believed that multiple pressures on staff, lack of incentives, non-availability of medication and lack of formal referral pathways resulted in disintegration of dealing with schizophrenia patients in primary care facilities. CONCLUSION: The study has identified a number of barriers and facilitators to developing and delivering a psychosocial intervention to support people living with schizophrenia in Pakistan. In particular, the importance of involving spiritual and traditional healers was highlighted by our diverse group of stakeholders.

Supervised treatment in outpatients for schizophrenia plus (STOPS+): protocol for a cluster randomised trial of a community-based intervention to improve treatment adherence and reduce the treatment gap for schizophrenia in Pakistan.

INTRODUCTION: There is a significant treatment gap, with only a few community-based services for people with schizophrenia in low-income and middle-income countries. Poor treatment adherence in schizophrenia is associated with poorer health outcomes, suicide attempts and death. We previously reported the effectiveness of supervised treatment in outpatients for schizophrenia (STOPS) for improving treatment adherence in patients with schizophrenia. However, STOPS was evaluated in a tertiary care setting with no primary care involvement, limiting its generalisability to the wider at-risk population. We aim to evaluate the effectiveness of STOPS+ in scaling up the primary care treatment of schizophrenia to a real-world setting. METHODS AND ANALYSIS: The effectiveness of the STOPS+ intervention in improving the level of functioning and medication adherence in patients with schizophrenia in Pakistan will be evaluated using a cluster randomised controlled trial design. We aim to recruit 526 participants from 24 primary healthcare centres randomly allocated in 1:1 ratio to STOPS+ intervention and enhanced treatment as usual arms. Participants will be followed-up for 12 months postrecruitment. The sample size is estimated for two outcomes (1) the primary clinical outcome is level of functioning, measured using the Global Assessment of Functioning scale and (2) the primary process outcome is adherence to treatment regimen measured using a validated measure. An intention-to-treat approach will be used for the primary analysis. ETHICS AND DISSEMINATION: Ethical approval has been obtained from Keele University Ethical Review Panel (ref: MH-190017) and Khyber Medical University Ethical Review Board (ref: DIR-KMU-EB/ST/000648). The results of the STOPS+ trial will be reported in peer-reviewed journals and academic conferences and disseminated to local stakeholders and policymakers. TRIAL REGISTRATION NUMBER: ISRCTN93243890.

Explanatory model of illness of the patients with schizophrenia and the role of educational intervention.

This randomized controlled trial was conducted at Department of Psychiatry, Lady Reading Hospital, Peshawar from February to August 2015 to explore beliefs and concepts of patients with schizophrenia about their illness and to find out the effectiveness of structured educational intervention in changing the explanatory models of illness of the patients and in their symptoms reduction. One hundred and three patients were recruited in the trial who were randomly assigned to two groups i.e., Experimental (n=53) and Control i.e., Treatment As Usual, TAU (n=50). Intervention was applied to experimental group only, once a month for three months. Short Explanatory Model Interview (SEMI), Brief Psychiatric Rating Scale (BPRS), Positive And Negative Syndrome Scale (PANSS), Global Assessment of Functioning (GAF) and Compliance Rating Scale were applied on all patients at baseline and at 3months follow up. Scores on PANSS (Total), BPRS and GAF showed improvement in the experimental group as compared to TAU group, at follow up, with the p values of 0.000, 0.002 and 0.000, respectively. On follow up, 44 (95.6%) patients of experimental group achieved complete compliance as compared to 17 (47.2%) patients of TAU group [p=0.000]. On baseline analysis of SEMI, in the experimental group, only 3.8% (n=2) knew about name of the illness, which increased to 54.3% (n=25) on follow up, while in TAU group it improved to 5.6% (n=2) as compared to 0% at baseline (p=0.000). The result suggest that Structured educational intervention can be effective in modifying the beliefs of the patients regarding their illness.