Muva physical activity intervention to improve social functioning in people with a severe mental illness: study protocol of a pragmatic stepped wedge cluster randomized trial

Abstract

Background People with severe mental illness (SMI) often suffer from long-lasting symptoms that negatively influence their social functioning, their ability to live a meaningful life, and participation in society. Interventions aimed at increasing physical activity can improve social functioning, but people with SMI experience multiple barriers to becoming physically active. Besides, the implementation of physical activity interventions in day-to-day practice is difficult. In this study, we aim to evaluate the effectiveness and implementation of a physical activity intervention to improve social functioning, mental and physical health. Methods In this pragmatic stepped wedge cluster randomized controlled trial we aim to include 100 people with SMI and their mental health workers from a supported housing organization. The intervention focuses on increasing physical activity by implementing group sports activities, active guidance meetings, and a serious game to set physical activity goals. We aim to decrease barriers to physical activity through active involvement of the mental health workers, lifestyle courses, and a medication review. Participating locations will be divided into four clusters and randomization will decide the start of the intervention. The primary outcome is social functioning. Secondary outcomes are quality of life, symptom severity, physical activity, cardiometabolic risk factors, cardiorespiratory fitness, and movement disturbances with specific attention to postural adjustment and movement sequencing in gait. In addition, we will assess the implementation by conducting semi-structured interviews with location managers and mental health workers and analyze them by direct content analysis. Discussion This trial is innovative since it aims to improve social functioning in people with SMI through a physical activity intervention which aims to lower barriers to becoming physically active in a real-life setting. The strength of this trial is that we will also evaluate the implementation of the intervention. Limitations of this study are the risk of poor implementation of the intervention, and bias due to the inclusion of a medication review in the intervention that might impact outcomes. Trial registration This trial was registered prospectively in The Netherlands Trial Register (NTR) as NTR NL9163 on December 20, 2020. As the The Netherlands Trial Register is no longer available, the trial can now be found in the International Clinical Trial Registry Platform via: https://trialsearch.who.int/Trial2.aspx?TrialID=NL9163.

Prevalence and predictors of inappropriate prescribing in outpatients with severe mental illness

“…Below the methods are shortly described according to the CONSORT reporting guidelines, 27 and the full trial protocol of the Muva study is described elsewhere. 26…”

“…This study is part of the Muva study, a pragmatic open Stepped Wedge Cluster Randomized Trial of a physical activity intervention for patients with severe mental illness performed at a supported housing organization 26 and the University Medical Centre Utrecht. 26 This study used data from the baseline assessment, no data from the intervention period was used. Below the methods are shortly described according to the CONSORT reporting guidelines, 27 and the full trial protocol of the Muva study is described elsewhere.…”

“…Below the methods are shortly described according to the CONSORT reporting guidelines, 27 and the full trial protocol of the Muva study is described elsewhere. 26 A supported housing organization is an organization that supports patients with severe mental illness in their rehabilitation by giving assistance in their daily lives. The organization does not provide psychiatric treatment, all patients in this study received ambulatory care from a psychiatrist or received psychiatric care from their general practitioner.…”