No registrations found.
ID
Source
Brief title
Health condition
Bipolar disorder, recurrent depression
Sponsors and support
Intervention
Outcome measures
Primary outcome
Quality of life (defined as the sum score on a QoL questionnaire) en activity level (defined as the number of steps per day)
Secondary outcome
Well-being, decreased psychiatric symptoms and metabolic parameters such as decreased body mass
and decreased glucose level, blood pressure and lipid spectra
Background summary
Patients with a bipolar disorder or severe depression have 10 years shorter life expectancy compare to the general population. The
most important causes are: somatic complications due to a sedentary habits and an unhealthy lifestyle related to their disorder
and/or the side effects of psychotropics they are using. Lifestyle interventions are in general as effective as drugs-based
interventions are. There is ample research on the efficacy of lifestyle interventions for outpatients with a psychiatric disorder. This
study will investigate whether a personalized lifestyle intervention may help to improve the health and quality of live of outpatients
with an affective disorder. The goal of the study is to develop a state-of-the art- lifestyle intervention that is achievable and acceptable for patients with a
bipolar and severe recurrent depressive disorder. Topics are moving, diet, sleep and sustenance. The focus
in on small changes that can be easily incorporated in the daily life of the patient. The planned duration is six months, with 9 weekly
sessions and 9 biweekly sessions of 1.5 hours, interspersed with individuals sessions and group sessions. One individual from the
personal surroundings (preferable a housemate) should also participate. All sessions include individual home work and start with a
positive psychology intervention (PPI) of 10 - 15 minutes.This is an exploratory pilot study with a case series design without control group. Patients follow a lifestyle intervention and are
assessed at baseline, after each module of the intervention en after the intervention (directly after and 6 months follow-up) with
interviews/questionnaires.
Study objective
The lifestyle intervention will result in increased activity of the participant and a higher quality of life.
Study design
Baseline, halfway, end of intervention and 6 month follow-up, also small evaluation after each of the modules of the intervention.
Intervention
A personalized lifestyle intervention will be investigated. Topics are moving, diet, sleep and sustenance. The focus
in on small changes that can be easily incorporated in the daily life of the patient. The planned duration is six months, with 9 weekly
sessions and 9 biweekly sessions of 1.5 hours, interspersed with individuals sessions and group sessions.
Inclusion criteria
Outpatients with a diagnosis op bipolar disorder or chronic, recurrent depression
Age 18 - 65 years
Abnormal outcome on three out of five criteria for metabolic syndrome
Availability of a buddy that will also participate
Exclusion criteria
Insufficient command of the Dutch language
Design
Recruitment
IPD sharing statement
Plan description
Followed up by the following (possibly more current) registration
Other (possibly less up-to-date) registrations in this register
No registrations found.
In other registers
| Register | ID |
|---|---|
| NTR-new | NL8232 |
| CCMO | NL72226.099.19 |
| OMON | NL-OMON49295 |