Evaluation of a Multidisciplinary Lifestyle Treatment for Inpatients With Mental Illness

Study Overview
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Brief Summary
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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
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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).

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

Conditions
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Mental Illness, Lifestyle

Intervention / Treatment
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* Behavioral: MULTI+


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 16 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Sequential Assignment
Interventional Model Description: Prospective open cohort stepped wedge cluster randomized trial
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| No Intervention: TAU<br>Treatment as usual (TAU); consist mainly of pharmacological treatment and psychotherapy. | |
| Experimental: MULTI+<br>Lifestyle treatment | Behavioral: MULTI+<br>* 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.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in metabolic health: Waist circumference | waist circumference measured halfway between the iliac crest and lowest rib in standing position | 4 measurements semi-annually over a period of 24 months | 
| Change in metabolic health: Systolic and diastolic blood pressure | Measured systolic and diastolic blood pressure (mmHg) | 4 measurements semi-annually over a period of 24 months | 
| Change in metabolic Health:Lipids | Values in blood sample | 4 measurements semi-annually over a period of 24 months | 
| Change in metabolic Health: HDL Cholesterol | Values in blood sample | 4 measurements semi-annually over a period of 24 months | 
| Change in metabolic Health: triglycerides | Values in blood sample | 4 measurements semi-annually over a period of 24 months | 
| Change in metabolic Health: Fasting glucose | Values in blood sample | 4 measurements semi-annually over a period of 24 months | 
| Weight Change | Weight is measured to the nearest 0.1 kg. | 4 measurements semi-annually over a period of 24 months | 
| Change in BMI | weight divided by height in meters squared | 4 measurements semi-annually over a period of 24 months | 
| Change in medication use through daily defined doses (DDD) | Medication prescribed for cardiovascular health and diabetes, and psychotropic medication will be converted into daily defined doses (DDD) according the Anatomical Therapeutic Chemical Classification System from the World Health Organization (WHO). Medication data is obtained from patient files. | 4 measurements semi-annually over a period of 24 months | 
| Change in psychosocial functioning: Adults | Measured by the Health of the Nations Outcomes Scale (HoNOS-12). All items are scored on a 5-point Likert scale, ranging from 0 (no problem) to 4 (severe problem). | 4 measurements semi-annually over a period of 24 months | 
| Change in psychosocial functioning: Elderly | Measured by the Health of the Nations Outcomes Scale (HoNOS-65+). All items are scored on a 5-point Likert scale, ranging from 0 (no problem) to 4 (severe problem). | 4 measurements semi-annually over a period of 24 months | 
| Change in psychosocial functioning: Adolescents | Measured by the Health of the Nations Outcomes Scale (HoNOSCA). All items are scored on a 5-point Likert scale, ranging from 0 (no problem) to 4 (severe problem). | 4 measurements semi-annually over a period of 24 months | 
| Change in substance use | Measured by routine questions about smoking, alcohol use and soft drugs | 4 measurements semi-annually over a period of 24 months | 
| Change in diet | Measured by a 24-hour dietary recall (24HR) | 4 measurements semi-annually over a period of 24 months | 
| Change in dietary habits | Measured by the Three Factor Eating Questionnaire Revised 18-items (TFEQ-R18), which consists of 18 items on a 4 point measuring scale, measuring cognitive restraint, uncontrolled eating and emotional eating. Raw scale scores are transformed on a scale from 0-100 (raw score- lowest possible score/possible raw score range)*100). | 4 measurements semi-annually over a period of 24 months | 
| Change in physical activity (PA): PaVs | Measured by the physical activity vital sign (PaVs). The PaVs is a two-item questionnaire, recommended as a brief way to routinely gain insight in physical activity levels. The PaVs can be used to assess whether the national activity guideline for aerobic activity are met in the context of health considerations (yes = 1, no = 0). Higher score means that the national activity guidelines are met. | 4 measurements semi-annually over a period of 24 months | 
| Change in physical activity (PA): SIMPAQ | Measure by the Simple Physical activity Questionnaire (SIMPAQ). The SIMPAQ consists of five items (boxes), and participants are asked about time spent in bed (box 1), time sedentary, including naps (box 2), time spent walking (box 3), time spent exercising (box 4) and time spent in incidental activity, such as housekeeping (box 5). The total self-reported time spent on moderate-vigorous physical activity (MVPA) can be calculated by adding box 4 and 5. | 4 measurements semi-annually over a period of 24 months | 
| Change in sleep (SCOPA-sleep) | Measured by the Scales for Outcomes in Parkinson's Disease - Sleep (SCOPA-Sleep). The SCOPA-Sleep is developed to evaluate night-time sleep and daytime sleepiness in a short and practical manner. The questionnaire enquires about the use of sleep medication and if so, which medication. It then uses 5 items to evaluate night-time sleep, 1 question inquiring overall quality of sleep followed by 6 items to evaluate daytime sleepiness on a 4 point Likert scale ranging from 0 (not at all) to 4 (a lot). | 4 measurements semi-annually over a period of 24 months | 
| Change in psychopathology (BSI) | Measured by the Brief Symptom Inventory (BSI). The BSI comprises 53 items that reflect 9 symptom domains of psychopathology (somatization, obsessive compulsive, interpersonal sensitivity, depression, anxiety, hostility, phobic anxiety, paranoid ideation and psychoticism). Each item is rated on a 5-point scale of distress from 0 (not at all) to 4 (extremely). | 4 measurements semi-annually over a period of 24 months | 
| Change in Quality of life (WHOQoL-Bref) | Measured by the World Health Organisation Quality of Life-BREF (WHOQoL-BREF). The four WHOQoL-BREF domains are measured through 24 domain-specific items: Physical health (7 items), Psychological (6 items), Social relations (3 items) and Environment (8 items) and two general health items. Item scores have various options but always range from 1 to 5, such as very poor to very good or not at all to extremely, and will be converted to domain scores (range from 4 to 20) based on the WHO guidelines. Higher score reflect a better quality of life. | 4 measurements semi-annually over a period of 24 months | 
| Change in Quality of life (EQ-5D) | Measured by the EuroQol 5D (EQ-5D).The EQ-5D is a generic instrument that consists of 5 dimensions of health, with one item per dimension; mobility, selfcare, usual activities, pain/discomfort, and anxiety/depression. There are three levels of severity ranging from no issues to many issues. The index score are calculated ranging from 0 (worst quality of life) to 1 (perfect quality of life). | 4 measurements semi-annually over a period of 24 months | 
| Change in meaning in life (MHC-SF) | Measured by the Mental Health Continuum - Short Form (MHC-SF). The MHC-SF measures positive mental health and consists of 14 items, representing feelings of well-being: Emotional well-being (three items), Psychological well-being (six items), and Social well-being (five items). Participants rate the frequency of these feelings in the past month on a 6-point Likert scale (never, once or twice a month, about once a week, two or three times a week, almost every day, every day). | 4 measurements semi-annually over a period of 24 months | 
| Barriers and facilitators of the implementation of the MULTI+ (MIDI) | Measured by the Measurement Instrument for Determinants of the Innovation (MIDI). The MIDI is comprised of 28 items, divided into 4 scales measuring determinants associated with innovations (7 items), the user (11 items) and the organization (10 items). All items are scored on a 5-point Likert scale ranging from 1 (totally disagree) to 5 (totally agree). Items which ≥20% responds negatively (disagree/totally disagree) are considered barriers. Items which ≥80% respond positively (agree/totally agree) are considered facilitators. | 4 measurements semi-annually over a period of 24 months | 
| Change in amount of adverse events | Institutional software in which employees register and categorize adverse events (e.g. aggression). | 24 months | 
| Change in motivation for behavioural regulation for physical activity | Measured by the Behavioural Regulation in Exercise Questionnaire (BREQ-2). The BREQ-2 is comprised of 19 items, divided into 5 scales measuring; Amotivation (item 5, 9 12, 19), External (item 1, 6, 11, 16), Identified (item 2, 7, 13), Introjected (item 3, 8, 14, 17), and Intrinsic (item 4, 10, 15, 18 ) regulations. The mean scores for each scale can be used as a multidimensional instrument, giving separate scores for each subscale. | 4 measurements semi-annually over a period of 24 months | 
| Change in motivation for behavioural regulation for healthy diet | Based on the BREQ-2 as used in this study, the researchers devised a behavioural regulation diet questionnaire. All mentioning of exercise in the BREQ-2 has been replaced by referring to (eat a) healthy diet. This questionnaire comprised of 19 items, divided into 5 scales measuring; Amotivation (item 5, 9 12, 19), External (item 1, 6, 11, 16), Identified (item 2, 7, 13), Introjected (item 3, 8, 14, 17), and Intrinsic (item 4, 10, 15, 18 ) regulations. The mean scores for each scale can be used as a multidimensional instrument, giving separate scores for each subscale. | 4 measurements semi-annually over a period of 24 months | 
| Health Technology Assessment (HTA) | Cost-effectiveness will be investigated through calculation of the costs of treatment as usual as compared to costs of MULTI+ | 24 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Inpatients, Implementation