Group therapy for a healthier lifestyle in psychiatric patients
| ISRCTN | ISRCTN91030407 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN91030407 |
| Secondary identifying numbers | 181024 |
- Submission date
- 18/10/2024
- Registration date
- 30/10/2024
- Last edited
- 14/11/2024
- Recruitment status
- Recruiting
- Overall study status
- Ongoing
- Condition category
- Mental and Behavioural Disorders
Plain English Summary
Background and study aims
People with severe mental illness (SMI) often have unhealthy eating habits, even though they usually understand what a healthy diet is and want to follow it. This study aims to compare the effects of a new group therapy approach with the usual treatment methods.
Who can participate?
People between 18 and 65 years old with a diagnosis of depression, bipolar disease or psychosis with a Body-Mass-Index (BMI) over 25 and the desire to lose weight.
What does the study involve?
The study involves two groups and participants will be assigned randomly to one of the groups. The control group involves the usual treatment (nutritional counseling and standard group therapy). The intervention group involves the usual treatment, but the standard group therapy is replaced with a new group therapy specificially designed to help patients change their dietary behavior. The new group therapy takes place once a week for a duration of 8 weeks. All patients will be tested before and after the treatment (blood sample, stool sample, dietary behavior, physical activity, psychological assessment, sociodemographic data, medical history, current medication and treatment).
What are the possible benefits and risks of participating?
There is no additional risk for the control group. For the intervention group, there is a minimal risk associated with the psychotherapy elements of the new group therapy, which has not been tested yet.
Nutritional counseling is known to have positive effects on dietary behavior. In general, group therapy is an effective psychotherapeutic intervention.
Participants will receive CHF 100 for their time spent.
Where is the study run from?
The Psychiatric University Hospital Zurich, Switzerland.
When is the study starting and how long is it expected to run for?
October 2024 to June 2027
Who is funding the study?
Stiftung zur Förderung von Psychiatrie und Psychotherapie (Zürich, Switzerland)
Fonds für wissenschaftliche Zwecke im Interesse der Heilung von psychischen Krankheiten (Zürich, Switzerland)
Who is the main contact?
Dr med. Florian Hotzy, florian.hotzy@pukzh.ch
Dr Eileen Neumann, eileen.neumann@gmx.ch
Contact information
Public, Scientific, Principal Investigator
Psychiatrische Universitätsklinik Zürich
Militärstrasse 8
Zürich
8021
Switzerland
 ORCID ID |
0000-0001-8543-6265 |
|---|---|
| Phone | +41583847471 |
| eileen.neumann@pukzh.ch |
Study information
| Study design | Monocenter open-label randomized head-to-head study with two study arms |
|---|---|
| Primary study design | Interventional |
| Secondary study design | Randomised controlled trial |
| Study setting(s) | Hospital |
| Study type | Treatment |
| Participant information sheet | Not available in web format, please use contact details to request a participant information sheet. |
| Scientific title | Behavioral therapy to induce a healthier lifestyle and more self-efficacy in psychiatric patients (HEALTH study): A naturalistic randomized controlled trial |
| Study acronym | HEALTH |
| Study hypothesis | Study participants receiving the HEALTH intervention will have better anthropometric measures (BMI and WHR) after the intervention (T1) and in the long term (T2) compared to individuals receiving TAU only. |
| Ethics approval(s) |
Submitted 13/11/2024, Kantonale Ethikkommission Zürich (Stampfenbachstrasse 121, Zürich, 8090, Switzerland; +41 43 259 79 70; info.kek@kek.zh.ch), ref: 2024-02177 |
| Condition | Psychosis, depression, bipolar disease |
| Intervention | HEALTH Intervention: The intervention is planned to consist of 8 group sessions in groups of 5–10 patients every 7 days. The sessions cover the following main topics: - Healthy diet - Physical activity - Circadian rhythm Therapeutic focus is set on: behavioral therapy support to identify and change problem behavior, small goals (microsteps), and enhance self efficacy. The control group will receive treatment as usual (TAU): Nutritional counseling plus group sessions in a standard group therapy (e.g. art therapy or recreational contact group). RedCap software will be used for assignment either to the intervention or control group (allocation ratio 1:1, block randomization). |
| Intervention type | Behavioural |
| Primary outcome measure | 1. BMI is measured using weight and height at baseline (T0), week 9 (T1), and week 24 (T2) 2. WHR is measured using a measuring tape at baseline (T0), week 9 (T1), and week 24 (T2) |
| Secondary outcome measures | 1. Inflammatory markers are measured using a venous blood sample of 24 ml at baseline (T0), week 9 (T1), and week 24 (T2) 2. Gut microbiome composition is measured using a stool sample at baseline (T0), week 9 (T1), and week 24 (T2) 3. Dietary behavior is measured using the Rapid-Eating-Assessment of Participants-Short version (REAP-S), Food-Frequency-Questionnaire (FFQ), Practical Knowledge about Balanced Meals scale (PKB-7), and Salzburg Emotional Eating Scale (SEES) at baseline (T0), week 9 (T1), and week 24 (T2) 4. Physical activity is measured using the Xiaomi Smart Band 8 and a self-rating scale for physical activity at baseline (T0), week 9 (T1), and week 24 (T2) 5. Psychological assessment is measured using the Goal Attainment Scale (GAS), Beck Depression Inventory (BDI), Self-efficacy Scale (SWE), Symptom-Checklist (SCL-K-9), World Health Organization Quality of Life (WHOQOL-BREF), and Schlafqualitäts-Fragebogen (PSQI) at baseline (T0), week 9 (T1), and week 24 (T2) |
| Overall study start date | 18/10/2024 |
| Overall study end date | 30/06/2027 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Lower age limit | 18 Years |
| Upper age limit | 65 Years |
| Sex | Both |
| Target number of participants | 100 |
| Participant inclusion criteria | 1. Age 18-65 years 2. SMI including ICD-10 F2 or F3 diagnosis 3. BMI >25 kg/m² and desire to lose weight |
| Participant exclusion criteria | 1. Comorbid substance use disorder (F1) or eating disorder (F5) 2. Current medical conditions such as acute infectious disease 3. Taking medication to reduce weight (e.g. GLP-1 receptor agonists) and participating in another nutritional counselling |
| Recruitment start date | 01/01/2025 |
| Recruitment end date | 31/12/2026 |
Locations
Countries of recruitment
- Switzerland
Study participating centre
Zürich
8021
Switzerland
Sponsor information
University/education
Rämistrasse 71
Zurich
8006
Switzerland
| Phone | +41 58 384 65 00 |
|---|---|
| florian.hotzy@pukzh.ch | |
| Website | http://www.uzh.ch/index_en.html |
"ROR" |
https://ror.org/02crff812 |
Funders
Funder type
University/education
No information available
No information available
Results and Publications
| Intention to publish date | 31/12/2028 |
|---|---|
| Individual participant data (IPD) Intention to share | Yes |
| IPD sharing plan summary | Available on request |
| Publication and dissemination plan | After the statistical analysis of this trial the sponsor will make every endeavor to publish the data in a peer-reviewed scientific journal. It is intended to make the publications available via open-access options. Also, the core results will be presented at scientific conferences. Those participants who expressed interest in the results will also be informed about the results using a presentation for laymen. |
| IPD sharing plan | The datasets generated during and / or analysed during the current study will be available upon request from Dr. med. Florian Hotzy (florian.hotzy@pukzh.ch). |
Editorial Notes
14/11/2024: Ethics submission date and reference added.
18/10/2024: Study's existence confirmed by Psychiatric University Clinic Zurich.
