NCT04922749: MULTI+

Evaluation of a Multidisciplinary Lifestyle Treatment for Inpatients With Mental Illness

Status unknown NA Last updated 16 November 2021

What this trial tests

NA trial testing MULTI+ in Mental Illness in 846 participants. Status unknown.

Timeline

1 July 2020

Primary endpoint
1 September 2022

1 September 2022

Quick facts

Lead sponsor	GGZ Centraal
Phase	NA
Status	Status unknown
Study type	INTERVENTIONAL
Allocation	randomized
Design	sequential
Masking	none
Primary purpose	treatment
Enrollment	846
Start date	1 July 2020
Primary completion	1 September 2022
Estimated completion	1 September 2022
Sites	1 location across Netherlands

Drugs / interventions tested

• MULTI+

Conditions studied

• Mental Illness — all drugs for Mental Illness →
• Lifestyle — all drugs for Lifestyle →

Sponsor

GGZ Centraal

Who can join

16 and older, any sex, with Mental Illness or Lifestyle. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

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+).

Publications & conference data

4 peer-reviewed publications reference this trial (live from Europe PMC):

1. Effectiveness and implementation of a multidisciplinary lifestyle focused approach in the treatment of inpatients with mental illness (MULTI +): a stepped wedge study protocol.
   den Bleijker NM, van Schothorst MME, Hendriksen IJM, Cahn W, et al · · 2022 · cited 4× · PMID 35361168 · DOI 10.1186/s12888-022-03801-w
2. Evaluating the Impact of a Lifestyle-Focused Approach on Cardiovascular Risk in Inpatients With Mental Illness: Analyzing Effectiveness and Fidelity in a Stepped Wedge Cluster Randomized Trial (MULTI+ Study V).
   den Bleijker NM, van Schothorst MME, Reitsma JB, Hendriksen IJM, et al · · 2025 · PMID 40932842 · DOI 10.1176/appi.prcp.20240150
3. Barriers and facilitators of inpatients and healthcare professionals prior to the implementation of a Multidisciplinary Lifestyle-Focused Approach in the Treatment of Inpatients With Mental Illness (MULTI+): The MULTI+ Study II.
   van Schothorst MME, den Bleijker NM, van Harten PN, De Vries NK, et al · · 2025 · PMID 40630921 · DOI 10.1177/26334895251351663
4. A network approach to lifestyle behaviors and health outcomes in people with mental illness: the MULTI+ study III.
   den Bleijker NM, van Schothorst MME, Blanken TF, Hendriksen IJM, et al · · 2025 · PMID 40211776 · DOI 10.1192/j.eurpsy.2025.2442