Clinical trial NCT04922749: Evaluation of a Multidisciplinary Lifestyle Treatment for Inpatients With Mental Illness
Official title: Evaluation of the Implementation and Effectiveness of a Multidisciplinary Lifestyle Treatment for Inpatients With Mental Illness (MULTI+)
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Mental Illness
Lifestyle
Keywords: Inpatients
Implementation
Lead sponsor: GGZ Centraal
Sponsor class: OTHER
Collaborators: name: Stichting tot steun VCVGZ
name: UMC Utrecht
name: Maastricht University
name: The Healthcare Innovation Centre
First posted: 2021-06-11
Enrollment: 846
Sex: ALL
Minimum age (years): 16
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: SEQUENTIAL
Intervention model description: Prospective open cohort stepped wedge cluster randomized trial
Primary purpose: TREATMENT

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+).

Detailed 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).

Eligibility criteria: Inclusion Criteria:

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

Exclusion Criteria:

* 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

Primary outcomes:
measure: QRISK3 score
timeFrame: 4 measurements semi-annually over a period of 24 months
Secondary outcomes:
measure: Change in metabolic health: Waist circumference
timeFrame: 4 measurements semi-annually over a period of 24 months
measure: Change in metabolic health: Systolic and diastolic blood pressure
timeFrame: 4 measurements semi-annually over a period of 24 months
measure: Change in metabolic Health:Lipids
timeFrame: 4 measurements semi-annually over a period of 24 months
measure: Change in metabolic Health: HDL Cholesterol
timeFrame: 4 measurements semi-annually over a period of 24 months
measure: Change in metabolic Health: triglycerides
timeFrame: 4 measurements semi-annually over a period of 24 months
measure: Change in metabolic Health: Fasting glucose
timeFrame: 4 measurements semi-annually over a period of 24 months
measure: Weight Change
timeFrame: 4 measurements semi-annually over a period of 24 months
measure: Change in BMI
timeFrame: 4 measurements semi-annually over a period of 24 months
measure: Change in medication use through daily defined doses (DDD)
timeFrame: 4 measurements semi-annually over a period of 24 months
measure: Change in psychosocial functioning: Adults
timeFrame: 4 measurements semi-annually over a period of 24 months
measure: Change in psychosocial functioning: Elderly
timeFrame: 4 measurements semi-annually over a period of 24 months
measure: Change in psychosocial functioning: Adolescents
timeFrame: 4 measurements semi-annually over a period of 24 months
measure: Change in substance use
timeFrame: 4 measurements semi-annually over a period of 24 months
measure: Change in diet
timeFrame: 4 measurements semi-annually over a period of 24 months
measure: Change in dietary habits
timeFrame: 4 measurements semi-annually over a period of 24 months
measure: Change in physical activity (PA): PaVs
timeFrame: 4 measurements semi-annually over a period of 24 months
measure: Change in physical activity (PA): SIMPAQ
timeFrame: 4 measurements semi-annually over a period of 24 months
measure: Change in sleep (SCOPA-sleep)
timeFrame: 4 measurements semi-annually over a period of 24 months
measure: Change in psychopathology (BSI)
timeFrame: 4 measurements semi-annually over a period of 24 months
measure: Change in Quality of life (WHOQoL-Bref)
timeFrame: 4 measurements semi-annually over a period of 24 months
measure: Change in Quality of life (EQ-5D)
timeFrame: 4 measurements semi-annually over a period of 24 months
measure: Change in meaning in life (MHC-SF)
timeFrame: 4 measurements semi-annually over a period of 24 months
measure: Barriers and facilitators of the implementation of the MULTI+ (MIDI)
timeFrame: 4 measurements semi-annually over a period of 24 months
measure: Change in amount of adverse events
timeFrame: 24 months
measure: Change in motivation for behavioural regulation for physical activity
timeFrame: 4 measurements semi-annually over a period of 24 months
measure: Change in motivation for behavioural regulation for healthy diet
timeFrame: 4 measurements semi-annually over a period of 24 months
measure: Health Technology Assessment (HTA)
timeFrame: 24 months
Other outcomes:
measure: Process evaluation - Change in RE-AIM domains
timeFrame: 24 months
Locations:
city: Amersfoort
country: Netherlands
facility: GGz Centraal
state: Utrecht
Study officials:
References:
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citation: 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.
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citation: 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.
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citation: 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.