Peer support for people with severe mental illness versus usual care: study protocol for a pragmatic multicentre randomised controlled trial (UPSIDES-RCT)

Abstract Background: Peer support is an established intervention involving a person in recovery from mental illness being engaged to offering support to others with mental illness. Peers are an under-used resource in global mental health. Building upon comprehensive formative research, this study will rigorously evaluate the impact of peer support at the levels of service users (psychosocial and clinical outcomes), peer support workers (work role, empowerment), services (cost-effectiveness, return on investment), and implementation (adoption, sustainability, organisational change). Methods: UPSIDES-RCT is a pragmatic parallel-group multi-centre randomised controlled trial assessing the effectiveness of UPSIDES at four measurement points over one year (baseline, 4-, 8-, and 12-month follow-up), and embedded process evaluation and cost-effectiveness analysis. Research will take place in a range of high-, middle- and low-income countries (Germany, United Kingdom, Israel, Uganda, Tanzania, India). The primary outcome is social inclusion of service users with severe mental illness (N= 558; N = 93 per site) at 8-month follow-up, measured with the Social Inclusion Scale. Secondary outcomes include empowerment (Empowerment Scale), hope (HOPE scale), recovery (Stages of Recovery), and health and social functioning (Health of the Nations Outcome Scales). Mixed-methods process evaluation will investigate mediators and moderators of effect, and implementation experiences of four UPSIDES stakeholder groups (service users, peer support workers, mental health workers, and policy makers). A cost-effectiveness analysis examining cost-utility and health budget impact will estimate the value for money of UPSIDES peer support. Discussion: By implementing and evaluating a manualized peer support intervention for people with severe mental illness across low-, middle-, and high-income countries, this study will contribute to harmonising core elements of peer support across different cultural and organisational dimensions. The UPSIDES-RCT will explore the essential components necessary to create a peer support model in mental health care, while providing the evidence required to sustain and eventually scale-up the intervention. Performance of mental health services will be maximised by actively involving and empowering service users, generating system changes towards user-centeredness, recovery orientation, community participation, and realising mental health as a human right. Trail registration: ISRCTN, ISRCTN26008944. Registered 30 October 2019, isrctn.com.