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. and patients in general practice with depression
ID
Source
Brief title
Condition
- Mood disorders and disturbances NEC
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
Feasibility and acceptability based on themes distilled by qualitative
interviews.
Secondary outcome
Quality of life, activity level (# of steps), wellbeing, decreased psychiatric
symptoms and metabolic parameters such as decreased body mass, increased
physical activity, and decreased glucose level, blood pressure and lipid
spectra. Lipid spectra and glucose level will not be assessed in general
practice.
Background summary
Patients with a bipolar disorder or severe depression have 10 years shorter
life expectancy compare to the general population.
Also patients with less severe depression who are often seen in primary care
are at risk and have shown to have a more than two times increased rate of
cardiovascular events The most important causes are: somatic complications due
to a sedentary habbits and an unhealty 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 lifstyle intervention may help to improve the health and quality
of live of outpatients with an affective disorder.
Study objective
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. and patients in general practice with depression
Study design
This is an explorative pilot studie 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 (direct erna en
6 maanden follow-up) with interviews/questionnaires, and a short physical
examination.
Intervention
A lifestyle intervention that helps to improve lifestyle in different modules.
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. De 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.
Study burden and risks
The burden of the study is considered to be minimal. In different modules
advises are given to promote a healthy lifestyle, but these have a advisory
instead of a compulsory character. Stated differently: no forced behavioral
changes are imposed. A reasonable part of the measurements are part of standard
care. Patients with be asked to wear a motion tracker, but the primary goal is
to motivate subject to move, not to track them.
Dennenweg 9
Assen 9404 LA
NL
Dennenweg 9
Assen 9404 LA
NL
Listed location countries
Age
Inclusion criteria
- For patients in mental health care only::
- Outpatients
- Aged between 18 and 65 years
- Diagnosed during intake, the primary diagnosis being chronic bipolar disorder
(type I or 2) or a chronic or recurrent severe depression in the narrower sense
of the word
- Receiving psychopharmacological treatment
- Have had a physical and lifestyle (MOPHAR) measurement showing that three or
more metabolic parameters were outside the normal range
For patients in general practice only:
- Diagnosis of depressive symptoms or depressive disorder in the past year as
registered in the general practice electronic health record and coded according
to the International Classification of Primary Care (ICPC) as P03 and P76,
respectively,
- At least mild depressive symptom level according to the Beck Depression
Inventory-II (BDI) (score >=14)
- Body mass index >= 25 kg/m2 or increased waist circumference (>88cm (women) of
>102cm (men)).
For both patient groups:
- Aged between 18 and 65 years
- Availability of one or two people close to the patient (friends or family,
preferably sharing the same household), i.e. to act as the buddy of the patient.
For the buddy there are no exclusion criteria.
Exclusion criteria
Insufficient command of the Dutch language
Design
Recruitment
Followed up by the following (possibly more current) registration
No registrations found.
Other (possibly less up-to-date) registrations in this register
In other registers
| Register | ID |
|---|---|
| CCMO | NL72226.099.19 |
| Other | NL8232 |