A peer delivered programme for mental health disclosure distress and internalised stigma (Let’s Talk) in comparison to treatment as usual in adults with psychosis: A randomised controlled trial to investigate the efficacy of a peer intervention targeted at stigma related mechanisms.

Research question: Our study will answer the primary question, what are the treatment effects of the internalised stigma (IS) targeted, peer-delivered intervention Let’s Talk + treatment as usual (TAU) for improving personal recovery compared to TAU in people with psychosis who report moderate to severe IS? The secondary research question is, do the key mechanisms of reduced IS and reduced stigma stress mediate the treatment effects of Let’s Talk on improved personal recovery?

Background: Psychosis is a serious mental health condition. Standard treatment typically includes antipsychotic medication, which targets psychiatric symptoms. However, recovery from psychosis is not limited to the reduction of psychiatric symptoms, but is a personal process involving rebuilding life, rebuilding self and hope.

Psychosis is highly stigmatised with pernicious stereotypes and high rates of discrimination. A harmful consequence of stigma is IS, which is associated with reduced personal recovery. A group based, peer intervention called Honest, Open and Proud (HOP) shows promise in reducing stigma related variables.

We conducted a feasibility Randomised Controlled Trial (RCT) of an adapted version of HOP, renamed Let’s Talk, which allows for individual delivery to people with psychosis by peer support workers (PSW) in the NHS. The RCT showed it is feasible and safe to conduct a RCT of the intervention. Although not powered to detect treatment effects, we found small effects at end of treatment and 6-month follow-up for improved personal recovery, moderate effects for reduced IS at end of treatment and large effects for IS at 6-month follow-up.

The minimal important difference for the Questionnaire about the Process of Recovery (QPR) is a 4–5-point increase. For the feasibility RCT, we observed a mean difference of 4 points at end of intervention. A clinical efficacy trial is now required.

Aims/objectives: To establish Let’s Talk’s clinical efficacy in a multisite RCT for adults with psychosis who report moderate to severe IS; and to assess whether improved measures of personal recovery are mediated via key stigma variables. The objective is to recruit 266 participants to detect a target difference of 4.5 points on the QPR, who will be randomised to Let’s Talk + TAU or TAU.

Methods: Participants will be recruited from NHS services across 4 UK sites. Primary outcome is total score on the QPR. Secondary clinical outcomes are depression, social anxiety, and quality of life.

The primary outcome will be analysed using a repeated measures mixed effect model accounting for baseline score, design covariates, nominal time, and treatment-by-time interaction, with participant and PSWs as random effects. The treatment window will be 4 months with mediational and outcome variables collected at baseline, 4-month follow-up (end of treatment) and 12-month follow-up. The project will be delivered over 40 months.

Anticipated impact/ dissemination: The study will investigate the clinical efficacy of a novel intervention deliverable in the NHS. Long-term benefits include improving the efficacy/accessibility of evidence-based psychosocial interventions for people with psychosis, responding to the NHS’s Long-term Plan for implementing a peer workforce with a targeted, manualised intervention.

Dissemination will occur via peer-reviewed articles, conference presentations, participant feedback, the intervention manual and workbook, and engagement with the service-users.