Evaluation of a Multidisciplinary Lifestyle Treatment for Inpatients With Mental Illness

NCT04922749 | Unknown

• 2 other identifiers: 200333277
• Study Type: interventional
• Target: 846
• Locations: 1 country
• Sites: 1

Brief 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+).

Conditions

Mental Illness; Lifestyle

Keywords

Inpatients; Implementation

Outcome Measures

Primary Outcomes (1)

• QRISK3 score

  Algorithm that estimates the probability of developing cardiovascular disease over the next 10 years by taking multiple risk factors into account.

  4 measurements semi-annually over a period of 24 months

Secondary Outcomes (27)

• Change in metabolic health: Waist circumference

  4 measurements semi-annually over a period of 24 months

• Change in metabolic health: Systolic and diastolic blood pressure

  4 measurements semi-annually over a period of 24 months

• Change in metabolic Health:Lipids

  4 measurements semi-annually over a period of 24 months

• Change in metabolic Health: HDL Cholesterol

  4 measurements semi-annually over a period of 24 months

• Change in metabolic Health: triglycerides

  4 measurements semi-annually over a period of 24 months

Other Outcomes (1)

• Process evaluation - Change in RE-AIM domains

  24 months

Study Arms (2)

TAU

NO INTERVENTION

Treatment as usual (TAU); consist mainly of pharmacological treatment and psychotherapy.

MULTI+

EXPERIMENTAL

Lifestyle treatment

Behavioral: MULTI+

Interventions

MULTI+ BEHAVIORAL

MULTI+ is a multidisciplinary, multicomponent treatment which aims to improve lifestyle factors through a holistic lifestyle approach, by focusing on 10 core components. The MULTI+ will be integrated into daily treatment to promote uptake and sustainability.

MULTI+

Eligibility Criteria

• Age: 16 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• years or older
• Mentally ill inpatients
• Receive care at the inpatient psychiatric wards of GGz Centraal where the MULTI+ will be implemented

You may not qualify if:

• Limited knowledge or understanding of Dutch
• If their psychiatric or physical condition hinders informed consent at the discretion of the relevant physician, nurses, or researcher

Sponsors & Collaborators

• GGZ Centraal: lead
• Stichting tot steun VCVGZ: collaborator
• UMC Utrecht: collaborator
• Maastricht University: collaborator
• The Healthcare Innovation Centre: collaborator

Study Sites (1)

GGz Centraal

Amersfoort, Utrecht, 3818 EW, Netherlands

RECRUITING

Related Publications (12)

• Hjorthoj C, Sturup AE, McGrath JJ, Nordentoft M. Years of potential life lost and life expectancy in schizophrenia: a systematic review and meta-analysis. Lancet Psychiatry. 2017 Apr;4(4):295-301. doi: 10.1016/S2215-0366(17)30078-0. Epub 2017 Feb 22.

  PMID: 28237639 BACKGROUND

• Correll CU, Solmi M, Veronese N, Bortolato B, Rosson S, Santonastaso P, Thapa-Chhetri N, Fornaro M, Gallicchio D, Collantoni E, Pigato G, Favaro A, Monaco F, Kohler C, Vancampfort D, Ward PB, Gaughran F, Carvalho AF, Stubbs B. Prevalence, incidence and mortality from cardiovascular disease in patients with pooled and specific severe mental illness: a large-scale meta-analysis of 3,211,768 patients and 113,383,368 controls. World Psychiatry. 2017 Jun;16(2):163-180. doi: 10.1002/wps.20420.

  PMID: 28498599 BACKGROUND

• Deenik J, Czosnek L, Teasdale SB, Stubbs B, Firth J, Schuch FB, Tenback DE, van Harten PN, Tak ECPM, Lederman O, Ward PB, Hendriksen IJM, Vancampfort D, Rosenbaum S. From impact factors to real impact: translating evidence on lifestyle interventions into routine mental health care. Transl Behav Med. 2020 Oct 8;10(4):1070-1073. doi: 10.1093/tbm/ibz067.

  PMID: 31169897 BACKGROUND

• Deenik J, Tenback DE, Tak ECPM, Hendriksen IJM, van Harten PN. [Thinking inside the box: improving the lifestyle of inpatients with severe mental illness]. Tijdschr Psychiatr. 2020;62(7):564-574. Dutch.

  PMID: 32700302 BACKGROUND

• Firth J, Siddiqi N, Koyanagi A, Siskind D, Rosenbaum S, Galletly C, Allan S, Caneo C, Carney R, Carvalho AF, Chatterton ML, Correll CU, Curtis J, Gaughran F, Heald A, Hoare E, Jackson SE, Kisely S, Lovell K, Maj M, McGorry PD, Mihalopoulos C, Myles H, O'Donoghue B, Pillinger T, Sarris J, Schuch FB, Shiers D, Smith L, Solmi M, Suetani S, Taylor J, Teasdale SB, Thornicroft G, Torous J, Usherwood T, Vancampfort D, Veronese N, Ward PB, Yung AR, Killackey E, Stubbs B. The Lancet Psychiatry Commission: a blueprint for protecting physical health in people with mental illness. Lancet Psychiatry. 2019 Aug;6(8):675-712. doi: 10.1016/S2215-0366(19)30132-4. Epub 2019 Jul 16. No abstract available.

  PMID: 31324560 BACKGROUND

• Firth J, Solmi M, Wootton RE, Vancampfort D, Schuch FB, Hoare E, Gilbody S, Torous J, Teasdale SB, Jackson SE, Smith L, Eaton M, Jacka FN, Veronese N, Marx W, Ashdown-Franks G, Siskind D, Sarris J, Rosenbaum S, Carvalho AF, Stubbs B. A meta-review of "lifestyle psychiatry": the role of exercise, smoking, diet and sleep in the prevention and treatment of mental disorders. World Psychiatry. 2020 Oct;19(3):360-380. doi: 10.1002/wps.20773.

  PMID: 32931092 BACKGROUND

• Suetani S, Rosenbaum S, Scott JG, Curtis J, Ward PB. Bridging the gap: What have we done and what more can we do to reduce the burden of avoidable death in people with psychotic illness? Epidemiol Psychiatr Sci. 2016 Jun;25(3):205-10. doi: 10.1017/S2045796015001043. Epub 2016 Jan 15.

  PMID: 26768358 BACKGROUND

• Firth J, Ward PB, Stubbs B. Editorial: Lifestyle Psychiatry. Front Psychiatry. 2019 Aug 26;10:597. doi: 10.3389/fpsyt.2019.00597. eCollection 2019. No abstract available.

  PMID: 31507466 BACKGROUND

• Hemming K, Haines TP, Chilton PJ, Girling AJ, Lilford RJ. The stepped wedge cluster randomised trial: rationale, design, analysis, and reporting. BMJ. 2015 Feb 6;350:h391. doi: 10.1136/bmj.h391. No abstract available.

  PMID: 25662947 BACKGROUND

• Koorts H, Eakin E, Estabrooks P, Timperio A, Salmon J, Bauman A. Implementation and scale up of population physical activity interventions for clinical and community settings: the PRACTIS guide. Int J Behav Nutr Phys Act. 2018 Jun 8;15(1):51. doi: 10.1186/s12966-018-0678-0.

  PMID: 29884236 BACKGROUND

• van Schothorst MME, den Bleijker NM, van Harten PN, De Vries NK, Deenik J. 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. Implement Res Pract. 2025 Jul 6;6:26334895251351663. doi: 10.1177/26334895251351663. eCollection 2025 Jan-Dec.

  PMID: 40630921 DERIVED

• den Bleijker NM, van Schothorst MME, Hendriksen IJM, Cahn W, de Vries NK, van Harten PN, Deenik J. Effectiveness and implementation of a multidisciplinary lifestyle focused approach in the treatment of inpatients with mental illness (MULTI +): a stepped wedge study protocol. BMC Psychiatry. 2022 Mar 31;22(1):230. doi: 10.1186/s12888-022-03801-w.

  PMID: 35361168 DERIVED

MeSH Terms

Conditions

Mental Disorders

Central Study Contacts

Jeroen Deenik, Dr.

CONTACT

+31622049524; j.deenik@ggzcentraal.nl

Myrthe van Schothorst, MSc

CONTACT

+3182648117; m.vanschothorst@ggzcentraal.nl

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SEQUENTIAL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Prospective open cohort stepped wedge cluster randomized trial

Study Record Dates

• First Submitted: June 3, 2021
• First Posted: June 11, 2021
• Study Start: July 1, 2020
• Primary Completion: September 1, 2022
• Study Completion: September 1, 2022
• Last Updated: November 16, 2021

Record last verified: 2021-06

Data Sharing

• IPD Sharing: Will not share

Locations

NL (1)