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A pilot randomized controlled trial investigating the feasibility, acceptability and preliminary (cost-)effectiveness and implementation of a combined lifestyle intervention for outpatients with a severe or chronic psychiatric illness (CHAPTER)

A pilot randomized controlled trial investigating the feasibility, acceptability and preliminary (cost-)effectiveness and implementation of a combined lifestyle intervention for outpatients with a severe or chronic psychiatric illness (CHAPTER) - CHAPTER pilot RCT

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
NL-OMON
Registry ID
NL-OMON53239
Enrollment
40
Registered
2023-05-30
Start date
2023-10-06
Completion date
Unknown
Last updated
2024-11-18

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Mental disorder psychiatric disorder

Interventions

Sponsors

Lentis (Groningen)
Lead Sponsor

Eligibility

Age
18 Years to 99 Years

Inclusion criteria

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

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 outcomes

Primary

MeasureTime frame
The primary outcome is the feasiblity and acceptability of the intervention and study procedures

Secondary

MeasureTime frame
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

Countries

Netherlands

Outcome results

None listed

Source: NL-OMON (via WHO ICTRP) · Data processed: Aug 31, 2026