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

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

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. 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. 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. 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

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