Meaningful Activities and Recovery (MA&R): the effect of a novel rehabilitation intervention among persons with psychiatric disabilities on activity engagement-study protocol for a randomized controlled trial.

backgroundEngagement in activities meaningful to the individual may support the process of recovery in those with mental illness. Persons with psychiatric disabilities may reduce their engagement in meaningful activities to various degrees with possible fluctuations over time. We hypothesized that activity engagement can be altered when opportunities and support are offered at an individual and a group peer-based level. Evidence is lacking regarding mental health interventions that enable engagement in meaningful activities, and powered effect studies are warranted.

methodsWe propose an 8-month combined individual and group peer-based intervention, Meaningful Activities and Recovery (MA&R), and a study protocol for a multicentre two-armed parallel randomized controlled trial (RCT). The trial investigates the effects of MA&R in community mental health centres in Copenhagen and municipality services in Denmark. The trial will comprise 128 participants with psychiatric disabilities who will be randomized to one of two groups: (1) MA&R in addition to standard mental healthcare or (2) standard mental healthcare alone. The primary outcome is self-reported activity engagement, measured by Profiles of Engagement in People with Severe Mental Illness. Secondary outcomes are recovery, functioning and quality of life. Data will be collected at baseline and at follow-up at the end of the intervention. DISCUSSION: This study adds new knowledge to a field with limited evidence, i.e. the clinical effectiveness of rehabilitation interventions among people with psychiatric disabilities, directly targeting activity engagement. The pragmatic design, regarding in- and exclusion criteria and settings, may allow assessment of the intervention's effect under real-life conditions. The randomization, adequate power and fidelity monitoring allow testing of the intervention's efficacy. The multicentre study design increases the potential for implementation in various mental health settings if the findings are positive. As the nature of the intervention does not permit blinding of the participants or staff, it may increase the risk of expectancy and performance bias. This must be considered when interpreting the findings.

trial registrationClinicalTrials.gov NCT03963245 . Registered on 29 May 2019.