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van CCT (UK)

van CCT (UK)

The implementation and evaluation of the "BeweegKuur Depressive Symptoms" in primary care

- candidate number15392
- NTR NumberNTR4168
- ISRCTNISRCTN wordt niet meer aangevraagd.
- Date ISRCTN created
- date ISRCTN requested
- Date Registered NTR10-sep-2013
- Secondary IDs12-439 METC
- Public TitleThe implementation and evaluation of the "BeweegKuur Depressive Symptoms" in primary care
- Scientific TitleThe implementation and (cost)effectiveness analysis of the "BeweegKuur Depressive Symptoms" in primary care
- hypothesisThe Beweegkuur Depressive Symptoms is more (cost-) effectiveness for adults with depressive symptoms in primary care than the use of the watchull waiting method.
- Healt Condition(s) or Problem(s) studiedDepression, Depressive symptoms, First line therapy, Physical activity, Occupational therapy, Cost-effectiveness , Implementation
- Inclusion criteriaParticipants 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
(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 criteriaThe General Practitioner decides whether a patient should be excluded from the study, for other (medical) reasons than stated at the inclusioncriteria.
- mec approval receivedyes
- multicenter trialyes
- randomisedyes
- masking/blindingNone
- controlActive
- groupParallel
- Type2 or more arms, randomized
- Studytypeintervention
- planned startdate 16-sep-2013
- planned closingdate1-jan-2016
- Target number of participants322
- InterventionsTen 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 exercise program of 3-6 months either independently or under supervision of the physiotherapist, a 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.
- Primary outcomeThe 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 outcomeOther 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.)
- Timepoints0, 3, 6 and 12 months
- Trial web siteN/A
- statusopen: patient inclusion
- Sponsor/Initiator Trimbos-institute - Netherlands Institute of Mental Health and Addiction
- Funding
(Source(s) of Monetary or Material Support)
ZON-MW, The Netherlands Organization for Health Research and Development
- PublicationsN/A
- Brief summaryA clustered, multi-centre, pragmatic randomized controlled trial (RCT) with a cost-effectiveness analysis (CEA) will be carried out to acquire knowledge about the costs and benefits of the BeweegKuur Depressive Symptoms for adults with depressive symptoms in primary care, versus a Watchful Waiting control group (follow-up period is 12 months). Also, a process evaluation will be executed to gain insight into the preconditions for successful implementation. A total of 20 primary care clinics will be randomized (10 experimental, 10 control) and we aim to include 322 participants in total. The primary outcome is change in depressive symptoms as measured by the Center for Epidemiologic Studies Depression Scale (the CES-D). Secondary outcomes include level of physical activity, psychological wellbeing, self efficacy, degree of self management, costs and quality of life.
- Main changes (audit trail)
- RECORD10-sep-2013 - 29-sep-2013

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