The objective of the study is to investigate the feasibilty, acceptabilty, implementation and preliminary (cost-)effectiveness of the intervention on recovery, health and lifestyle variables.
ID
Source
Brief title
Condition
- Psychiatric disorders NEC
- Lifestyle issues
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
The primary outcome is the feasiblity and acceptability of the intervention and
study procedures
Secondary outcome
Secundary outcomes are
-the preliminiary effects on recoveyr, health, and lifestyle variables,
-the preliminary costeffectiveness of the intervention,-
-the subjectively experienced effects of the intervention
-the barriers and fascilitators for implementation of the intervention in daily
practice
-the goals of participants during the intervention
Background summary
There is an urgent need for new and low-coast approaches in the prevention and
treatment of mental disorders. Lifestyle interventions, targeted at changing
habits in multiple domains, might be such a new approach. Lifestyle
interventions are known to improve somatic health, which is important for
individuals with a psychiatric illness since unhealthy lifestyle choices and
somatic illness are common in this population leading to a life expectancy loss
of 10-20 years and high rates of somatic comorbidity. The effects of lifestyle
interventions in individuals with a psychiatric illness on somatic health and
mental health are promising, but effects on other domains of recovery are
unknown. Research is needed to answer questions on efficacy, feasibility and
acceptability of combined lifestyle interventions in outpatients with a
psychiatric disorder.
Study objective
The objective of the study is to investigate the feasibilty, acceptabilty,
implementation and preliminary (cost-)effectiveness of the intervention on
recovery, health and lifestyle variables.
Study design
This pilot aims to recruit outpatients from multiple departments of Lentis with
a psychiatric disorder. The participants will be randomized to receive a
lifestyle intervention at onset of the trial (intervention group) or to receive
a delayed lifestyle intervention when the trial is finished (control group).
All participants will continue their treatment as usual during the trial.
Participants are screened on inclusion criteria and health risks (somatic
screening) before randomization.
Before, during and after the intervention both groups will be assessed on their
recovery, (broad) health and lifestyle behavior using questionnaires, somatic
assessments and daily diaries.
A subset of participants will be invited for an interview in which the
experiences and subjective effects of the training and study procedures will be
assessed.
Information on the barriers and fascilitators of implementation of the
intervention will be collected through the trainers.
Intervention
The lifestyle intervention targets healthy changes of habits in one or more of
the following domains: nutrition, physical activity, relaxation, sleep,
spirituality and substance use. The intervention consists of 12 weekly group
sessions and 3 3-weekly follow-up sessions. Besides, the participants are
provided with homework to practice with lifestyle in their daily life.
Study burden and risks
No severe risks are expected from the intervention or study procedures.
The intervention is expected to be beneficial to the participant in multiple
domains of health and recovery.
The measurement burden is 6 hours, with a total time investment of 8 hours.
This is spread over 6 months, resulting in a time investment of less than 20
minutes a week.
The intervention sessions have a total duration of 30-37.5 hours, with 36 hours
of homework. Attendance is recommended, but not mandatory.
Hereweg 80
Groningen 9725AG
NL
Hereweg 80
Groningen 9725AG
NL
Listed location countries
Age
Inclusion criteria
- Treated in an outpatient clinic of Lentis;
- Treated in specialist mental health care;
- Adult (18+);
- Capable to read, write and speak in the Dutch language;
- Available and capable to attend the intervention at set moments and
locations;
- Capable to follow the research procedures.
Exclusion criteria
- Main diagnosis of eating disorder or obsessive-compulsive disorder;
- In current crisis, severe symptoms, suicidality, self-mutilation or distorted
reality;
- Receiving guidance for at least three times in one or more lifestyle domains
on a frequent basis (at least once every other week) in the past year;
- Other implications for lifestyle interventions that cannot be overcome (e.g.
due to physical illness, use of certain medication such as clozapine or
intellectual disability);
- (Temporary) Hospitalization or living in a supported housing facility;
- Inability to comply with the study requirements as mentioned in the
participant information letter, judged by the research team;
- No informed consent is given.
Design
Recruitment
Followed up by the following (possibly more current) registration
No registrations found.
Other (possibly less up-to-date) registrations in this register
No registrations found.
In other registers
| Register | ID |
|---|---|
| CCMO | NL83935.042.23 |