|- candidate number||15392|
|- NTR Number||NTR4168|
|- ISRCTN||ISRCTN wordt niet meer aangevraagd.|
|- Date ISRCTN created|
|- date ISRCTN requested|
|- Date Registered NTR||10-sep-2013|
|- Secondary IDs||12-439 METC|
|- Public Title||The implementation and evaluation of the "BeweegKuur Depressive Symptoms" in primary care|
|- Scientific Title||The implementation and (cost)effectiveness analysis of the "BeweegKuur Depressive Symptoms" in primary care|
|- hypothesis||The 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) studied||Depression, Depressive symptoms, First line therapy, Physical activity, Occupational therapy, Cost-effectiveness , Implementation|
|- 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
(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 at the inclusioncriteria.|
|- mec approval received||yes|
|- multicenter trial||yes|
|- Type||2 or more arms, randomized|
|- planned startdate ||16-sep-2013|
|- planned closingdate||1-jan-2016|
|- Target number of participants||322|
|- Interventions||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 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 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.)
|- Timepoints||0, 3, 6 and 12 months|
|- Trial web site||N/A|
|- status||open: patient inclusion|
|- CONTACT FOR PUBLIC QUERIES|| Suzanne Lokman|
|- CONTACT for SCIENTIFIC QUERIES|| Suzanne Lokman|
|- Sponsor/Initiator ||Trimbos-institute - Netherlands Institute of Mental Health and Addiction|
(Source(s) of Monetary or Material Support)
|ZON-MW, The Netherlands Organization for Health Research and Development|
|- Brief summary||A 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)|
|- RECORD||10-sep-2013 - 29-sep-2013|