Evaluation of a Multidisciplinary Lifestyle Treatment for Inpatients With Mental Illness — MULTI+  

Mental Illness Clinical Trial

Official title: Evaluation of the Implementation and Effectiveness of a Multidisciplinary Lifestyle Treatment for Inpatients With Mental Illness (MULTI+)

Status Recruiting

Clinical Trial Summary

People with mental illness (MI) have a reduced life expectancy compared to the general population, mostly attributable to somatic diseases caused by poor physical health. Modifiable "lifestyle factors" have been increasingly associated with the onset of somatic diseases in people with MI and refer to health behaviours such as physical activity (PA), diet, sleep and smoking behaviour. Despite the evidence demonstrating the efficacy of interventions aimed at improving lifestyle factors, there have not been many structural changes in routine clinical care for people with MI. Using a multidisciplinary, multicomponent approach, Deenik and colleagues (2019) were the first to find long-term positive effects in both mental and somatic health in a real-world inpatient setting for people with severe mental illness (SMI). They found improvements in metabolic health, psychosocial functioning and quality of life, and a reduction in the use of psychotropic medication. The authors urged to confirm and complement findings in scaled-up studies, and made several suggestions for improvement of the treatment and pragmatic research of implementation. In line with these previous recommendations the MULTI is being scaled-up into the MULTI+. This study investigates the implementation and effectiveness of a multidisciplinary lifestyle treatment for inpatients with mental illness (MULTI+).

Clinical Trial Description

Study design and setting

This study is a prospective open cohort stepped wedge cluster randomized trial with continuous recruitment. This study is being conducted at the inpatient psychiatric wards, covering approximately 750 places of residency in which approximately 2000 patients are treated annually, from the specialist mental healthcare organisation GGz Centraal (the Netherlands). The study uses a stepped-wedge clustered design. The psychiatric wards are divided into three clusters, based on their geographical locations. These clusters gradually implement MULTI+ in semi-annual steps, such that all clusters are exposed to the MULTI+ at the end of the study. The repeated measurements are conducted on ward-level, rather than individual patient level.

Intervention

MULTI+ is a multidisciplinary, multicomponent treatment which aims to improve lifestyle factors through a holistic lifestyle approach, by focusing on 10 core components. Core components refer to essential elements and activities that are necessary to achieve desired outcomes. The core components of MULTI+ are based on previous recommendations and existing literature. The core components of MULTI+ are routine daily structure and sleep, physical activity, attention to nutrition and eating habits, smoking cessation, multidisciplinary treatment, skills training, psychoeducation, critical review of obesogenic environment and existing policies, active participation of health care professionals (HCPs), and training of HCPs. The core components are co-designed and tailored to the ward and patient population, because of the large heterogeneity in patient characteristics and varying access to facilities and staffing.

Analyses

To measure the intervention effect, linear mixed models will be used for continuous outcome measures and logistic mixed models for dichotomous outcome measures. In each model, the intervention effect will be estimated as the difference between the postintervention and preintervention levels of the outcome after adjusting for time as a categorical variable. All models will be corrected for group differences at baseline and the baseline differences of the outcome measures concerned (to account for regression to the mean). ;

Related Conditions & MeSH terms

• Lifestyle
• Mental Disorders
• Mental Illness

• NCT number: NCT04922749
• Study type: Interventional
• Source: GGZ Centraal
• Contact: Jeroen Deenik, Dr.
• Phone: +31622049524
• Email: j.deenik@ggzcentraal.nl
• Status: Recruiting
• Phase: N/A
• Start date: July 1, 2020
• Completion date: September 1, 2022