This study investigates if the BeweegKuur Depressive Symptoms is more (cost-)effective in comparison with "watchful waiting". Complementary, success factors and barriers of the implementation of the BeweegKuur Depressive Symptoms in…
ID
Source
Brief title
Condition
- Mood disorders and disturbances NEC
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
The primary outcome measure is the difference between "BeweegKuur Depressive
Symptoms" and "watchful waiting" in terms of change in depressive symptoms,
which will be measured with the CES-D.
Secondary outcome
Other outcomes include level of physical activity (frequency and duration),
psychological wellbeing, self efficacy, degree of self management and quality
of life. Measures will be conducted at baseline, and after three, six and
twelve months. To gain insight in the cost-effectiveness of the intervention,
the direct and indirect costs of the BeweegKuur Depressive Symptoms will be
collected (productivity losses, medicine.)
Background summary
The Netherlands Intstitute for Sports and Exercise developed the intervention
"BeweegKuur". This is a lifestyle program for people with (a high risk on)
overweight or diabetes type 2. The BeweegKuur will be adapted for people with
depressive symptoms. This study evaluates if the BeweegKuur Depressive Symptoms
is (cost)effective and identifies success factors and barriers in the
implementation of the BeweegKuur Depressive Symptoms.
Study objective
This study investigates if the BeweegKuur Depressive Symptoms is more
(cost-)effective in comparison with "watchful waiting". Complementary, success
factors and barriers of the implementation of the BeweegKuur Depressive
Symptoms in primary care are identified, to maximize participation of the
target group including people with a low socioeconomic status.
Study design
Pragmatic multicenter randomized controlled trial with a costeffective
analysis.
Intervention
Ten Primary care clinics will offer the BeweegKuur Depressive Symptoms
(experimental condition), and ten clinics will use the watchful waiting method
(control condition) as is prescribed in the Multidisciplinary Guideline
Depression. The BeweegKuur Depressive Symptoms consists of a tailored exersice
program of 3-6 months either independently or under supervision of the
physiotherapist, an suitable and desirable evidence-based psychological
intervention offered by the physician assistant-mental health, and for one's
under- or overweight consultation with a dietician. A life style advisor or
physician assistant-mental health supports the participant during one year.
Study burden and risks
After inclusion the participants of the study conduct four measurements. Every
measurement will take about 20 till 30 minutes to fill in different
questionnaires. The measurements do not lead to any risks.
Da Costakade 45
Utrecht 3521VS
NL
Da Costakade 45
Utrecht 3521VS
NL
Listed location countries
Age
Inclusion criteria
Participants are men and women, and are included in the study if they
(a) are at least 18 years of age,
(b) have a CES-D score of 6-46 (6-15 indicating some depressive symptoms, 16-46 indicating probably depression)
(c) do not have suicide ideation or concrete suicidal plans,
(d) currently fail to meet the Dutch norm for healthy physical activity (30 minutes of moderate to vigorous physical activity on at least 5 days per week) and are sufficiently motivated to change their physical activity level (to be judged subjectively by the primary care providers during intake), (e) do not have any psychological or psychiatric disorder or severe physical problems and other issues that will hinder participation in the BeweegKuur Depressive Symptoms,
(f) mastered the Dutch language sufficiently to fill in questionnaires
(g) gives written informed consent, and
(h) complete the t0 questionnaire.
Exclusion criteria
The General Practitioner decides whether a patient should be excluded from the study, for other (medical) reasons than stated in D4, main inclusioncriteria.
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 | NL41705.041.12 |