- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04922749
Evaluation of a Multidisciplinary Lifestyle Treatment for Inpatients With Mental Illness (MULTI+)
Evaluation of the Implementation and Effectiveness of a Multidisciplinary Lifestyle Treatment for Inpatients With Mental Illness (MULTI+)
Study Overview
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).
Study Type
Enrollment (Anticipated)
Phase
- Not Applicable
Contacts and Locations
Study Contact
- Name: Jeroen Deenik, Dr.
- Phone Number: +31622049524
- Email: j.deenik@ggzcentraal.nl
Study Contact Backup
- Name: Myrthe van Schothorst, MSc
- Phone Number: +3182648117
- Email: m.vanschothorst@ggzcentraal.nl
Study Locations
-
-
Utrecht
-
Amersfoort, Utrecht, Netherlands, 3818 EW
- Recruiting
- GGz Centraal
-
Contact:
- Jeroen Deenik, Dr.
- Phone Number: +31622049534
- Email: j.deenik@ggzcentraal.nl
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
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
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Sequential Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
No Intervention: TAU
Treatment as usual (TAU); consist mainly of pharmacological treatment and psychotherapy.
|
|
Experimental: MULTI+
Lifestyle treatment
|
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.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
QRISK3 score
Time Frame: 4 measurements semi-annually over a period of 24 months
|
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
Time Frame: 4 measurements semi-annually over a period of 24 months
|
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
Time Frame: 4 measurements semi-annually over a period of 24 months
|
Measured systolic and diastolic blood pressure (mmHg)
|
4 measurements semi-annually over a period of 24 months
|
Change in metabolic Health:Lipids
Time Frame: 4 measurements semi-annually over a period of 24 months
|
Values in blood sample
|
4 measurements semi-annually over a period of 24 months
|
Change in metabolic Health: HDL Cholesterol
Time Frame: 4 measurements semi-annually over a period of 24 months
|
Values in blood sample
|
4 measurements semi-annually over a period of 24 months
|
Change in metabolic Health: triglycerides
Time Frame: 4 measurements semi-annually over a period of 24 months
|
Values in blood sample
|
4 measurements semi-annually over a period of 24 months
|
Change in metabolic Health: Fasting glucose
Time Frame: 4 measurements semi-annually over a period of 24 months
|
Values in blood sample
|
4 measurements semi-annually over a period of 24 months
|
Weight Change
Time Frame: 4 measurements semi-annually over a period of 24 months
|
Weight is measured to the nearest 0.1 kg.
|
4 measurements semi-annually over a period of 24 months
|
Change in BMI
Time Frame: 4 measurements semi-annually over a period of 24 months
|
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)
Time Frame: 4 measurements semi-annually over a period of 24 months
|
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
Time Frame: 4 measurements semi-annually over a period of 24 months
|
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
Time Frame: 4 measurements semi-annually over a period of 24 months
|
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
Time Frame: 4 measurements semi-annually over a period of 24 months
|
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
Time Frame: 4 measurements semi-annually over a period of 24 months
|
Measured by routine questions about smoking, alcohol use and soft drugs
|
4 measurements semi-annually over a period of 24 months
|
Change in diet
Time Frame: 4 measurements semi-annually over a period of 24 months
|
Measured by a 24-hour dietary recall (24HR)
|
4 measurements semi-annually over a period of 24 months
|
Change in dietary habits
Time Frame: 4 measurements semi-annually over a period of 24 months
|
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
Time Frame: 4 measurements semi-annually over a period of 24 months
|
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
Time Frame: 4 measurements semi-annually over a period of 24 months
|
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)
Time Frame: 4 measurements semi-annually over a period of 24 months
|
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)
Time Frame: 4 measurements semi-annually over a period of 24 months
|
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)
Time Frame: 4 measurements semi-annually over a period of 24 months
|
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)
Time Frame: 4 measurements semi-annually over a period of 24 months
|
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)
Time Frame: 4 measurements semi-annually over a period of 24 months
|
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)
Time Frame: 4 measurements semi-annually over a period of 24 months
|
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
Time Frame: 24 months
|
Institutional software in which employees register and categorize adverse events (e.g.
aggression).
|
24 months
|
Change in motivation for behavioural regulation for physical activity
Time Frame: 4 measurements semi-annually over a period of 24 months
|
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
Time Frame: 4 measurements semi-annually over a period of 24 months
|
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)
Time Frame: 24 months
|
Cost-effectiveness will be investigated through calculation of the costs of treatment as usual as compared to costs of MULTI+
|
24 months
|
Other Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Process evaluation - Change in RE-AIM domains
Time Frame: 24 months
|
The process evaluation is conducted using the RE-AIM framework (RE-AIM).
Reach, Efficacy, Adoption, Implementation and Maintenance will be assessed continuously throughout the study.
There are no scores attached to the domains, rather, change is evaluated.
|
24 months
|
Collaborators and Investigators
Sponsor
Publications and helpful links
General Publications
- 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.
- 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. Erratum In: Lancet Psychiatry. 2017 Sep;4(9):e19.
- 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. Erratum In: World Psychiatry. 2018 Feb;17 (1):120.
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Anticipated)
Study Completion (Anticipated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- 200333
- 277 (Other Grant/Funding Number: Stichting tot steun VCVGZ)
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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