Evaluation of a Multidisciplinary Lifestyle Treatment for Inpatients With Mental Illness

Mental Illness Clinical Trial

— MULTI+  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04922749
• Other study ID #: 200333
• Secondary ID: 277
• Status: Recruiting
• Phase: N/A
• Start date: July 1, 2020
• Est. completion date: September 1, 2022

Study information

• Verified date: June 2021
• Source: GGZ Centraal
• Contact: Jeroen Deenik, Dr.
• Phone: +31622049524
• Email: j.deenik[@]ggzcentraal.nl
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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+).

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).

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 846
• Est. completion date: September 1, 2022
• Est. primary completion date: September 1, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 16 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Lifestyle
• Mental Disorders
• Mental Illness

Intervention

Behavioral:
• MULTI+
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.

Locations

Country	Name	City	State
Netherlands	GGz Centraal	Amersfoort	Utrecht

Sponsors (5)

Lead Sponsor	Collaborator
GGZ Centraal	Maastricht University, Stichting tot steun VCVGZ, The Healthcare Innovation Centre, UMC Utrecht

Country where clinical trial is conducted

Netherlands, 

References & Publications (10)

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. — View Citation

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. — View Citation

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. — View 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. Review. — View Citation

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. — View Citation

Firth J, Ward PB, Stubbs B. Editorial: Lifestyle Psychiatry. Front Psychiatry. 2019 Aug 26;10:597. doi: 10.3389/fpsyt.2019.00597. eCollection 2019. — View Citation

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. Review. — View Citation

Hjorthøj C, Stürup 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. — View Citation

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. — View Citation

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Process evaluation - Change in RE-AIM domains	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
Primary	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	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
Secondary	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
Secondary	Change in metabolic Health:Lipids	Values in blood sample	4 measurements semi-annually over a period of 24 months
Secondary	Change in metabolic Health: HDL Cholesterol	Values in blood sample	4 measurements semi-annually over a period of 24 months
Secondary	Change in metabolic Health: triglycerides	Values in blood sample	4 measurements semi-annually over a period of 24 months
Secondary	Change in metabolic Health: Fasting glucose	Values in blood sample	4 measurements semi-annually over a period of 24 months
Secondary	Weight Change	Weight is measured to the nearest 0.1 kg.	4 measurements semi-annually over a period of 24 months
Secondary	Change in BMI	weight divided by height in meters squared	4 measurements semi-annually over a period of 24 months
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	Change in diet	Measured by a 24-hour dietary recall (24HR)	4 measurements semi-annually over a period of 24 months
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	Change in amount of adverse events	Institutional software in which employees register and categorize adverse events (e.g. aggression).	24 months
Secondary	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
Secondary	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
Secondary	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

External Links

•   Information on the MULTI+ project