Psychosocial Rehabilitation and peer support for people with schIZophrEnia in South Africa (PRIZE): a pilot cluster-randomised trial

Schizophrenia is a mental illness that can lead to problems in family life and in keeping a job. Experts agree that a combination of medication and psychosocial rehabilitation (PSR) gives people with schizophrenia the best chance of recovery. PSR involves a support worker giving information, advice and support on topics such as understanding schizophrenia, taking medication, getting back to work and building relationships. Whilst the South African government supports this approach, in reality such programmes are rarely implemented because of a shortage of mental health professionals in South Africa. In a previous project, we developed group-based PSR for South Africa delivered by auxiliary social workers, who are not mental health specialists. Having non-specialists deliver the programme makes it more feasible to deliver widely, to reach the people with schizophrenia who need this support across the country. The people with schizophrenia who received PSR felt it was beneficial, but their family members were difficult to engage with and there was no ongoing support in place once the 4 month PSR programme had finished. We also found that we don't have accurate ways of measuring disability, unmet needs and recovery in people with schizophrenia in South Africa.

This project aims to improve on the previous PSR programme by finding better ways to involve caregivers and by adding a peer support component. Peer support groups involve service users sharing their experiences and jointly solving problems. Groups are led by service users on a voluntary basis. Peer support groups are a promising way to provide long-term psychosocial support in the community. It is hoped this new combined PSR and peer support programme could be implemented across South Africa and that it will be beneficial for service users. We will use the information from this study to plan a future larger study, which will give us better information on whether PSR and peer support works to improve outcomes of people with schizophrenia and whether it provides value for money.

The current study will last three years and is set in Nelson Mandela Bay District, Eastern Cape, South Africa. There are four objectives.

Objective 1 is to develop a combined PSR and peer support programme for people with schizophrenia that is suitable for the setting and addresses the problems in the previous PSR programme, including the lack of on-going support.
We will achieve Objective 1 by seeking the views of service users, caregivers, and health workers in participatory workshops and in-depth interviews and using the findings to design a new programme.

Objective 2 is to compare the combined PSR and peer support programme to stand-alone PSR in terms of how useful they are thought to be, and how practical they will be to implement into existing health services.
We will achieve Objective 2 by conducting a pilot study involving 100 service users with schizophrenia in 10 clinics. We will randomly allocate 5 of these clinics to receive PSR and peer support, whilst 5 clinics will receive only PSR. After 4 and 10 months we will ask service users their views on the services and assess whether their needs are being met.

Objective 3 is to improve assessments, in the form of short interviews, to more accurately measure disability, unmet needs and recovery. We hope these assessments can be used in future evaluations of PSR and peer support groups.
We will achieve Objective 3 by holding focus groups with service users and caregivers to understand how well the assessments capture their problems. We will then test the assessments to check they are easy to understand and use.

Objective 4 is to determine how practical it is to conduct a larger study of PSR and peer support in the future, and how many participants we would need to make the study worthwhile.
We will achieve Objective 4 by testing various procedures, such as recruitment of participants, in the pilot study.

Schizophrenia is associated with high levels of disability and family burden. Evidence-based guidelines and South African national policy support a combination of medication and community-based psychosocial rehabilitation (PSR) for people with schizophrenia. Implementation is currently limited due to a lack of evidence for feasible PSR models. A task-shared PSR intervention for schizophrenia was previously developed and tested by this research team. PSR was acceptable and beneficial to service users but caregivers were not engaged and long-term support was lacking. The aim of this project is to develop and pilot a hybrid model of PSR and peer support for people with schizophrenia in SA, which is feasible, scalable and has promising effects, in preparation for a definitive trial. Peer support groups - in which service users sustain and lead PSR groups as volunteers- are a promising approach to address the absence of long-term psychosocial support. This 3 year study is set in Nelson Mandela Bay District, Eastern Cape, SA. The objectives are
1.To co-produce a context-specific hybrid PSR and peer support programme for people with schizophrenia, that addresses previously identified barriers to effectiveness and feasibility, using workshops and qualitative interviews with service users, caregivers, and health workers.
2.To compare the hybrid PSR and peer support programme to stand-alone PSR in terms of acceptability, feasibility and health systems implications, in a 10-month pilot cluster randomised trial involving 100 service users and 100 caregivers in 10 clinics.
3.To develop and adapt contextually appropriate outcome and process measures for the future evaluation of PSR and peer support using focus groups and cognitive interviewing and to validate these measures in the pilot trial.
4.To use the pilot trial to estimate parameters in preparation for a definitive trial including recruitment and retention rates, and outcome data to support sample size calculations.

The PRIZE psychosocial rehabilitation and peer support intervention will be designed to improve functioning and quality of life for people with schizophrenia living with their families in South Africa. This will enable them to take up productive or income generating activities either in the formal or informal economy. It will reduce the burden of care for family members and enable them to pursue income-generating activities themselves. This will boost the overall social and economic development of the study district. The study has benefits for the health system and for health service providers. Improved functioning and long-term support may reduce hospital readmission and visits to primary care facilities, reducing workload for overburdened primary care staff. This will translate to overall cost savings for district health services. The study leaves sustainable resources for health and social development in the district by supporting people with schizophrenia and their caregivers to become peer supporters. It drives sustainable workforce development of district non-specialist community workers (auxiliary social workers) as facilitators of the PRIZE PSR programme, as well as their supervisors (social workers). The study builds intersectoral collaboration between the Departments of Health and Social Development and the non-governmental sector which has important potential for driving wider progress on health and development. Since the programme is designed for low-resource South African settings, the findings may be transferable to other low and middle income countries, producing a broader impact on health system strengthening in the region.