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van CCT (UK)

van CCT (UK)

The implementation of ColourYourLife in primary care.

- candidate number17503
- NTR NumberNTR4520
- ISRCTNISRCTN no longer applicable
- Date ISRCTN created
- date ISRCTN requested
- Date Registered NTR16-apr-2014
- Secondary IDs200210019 File number ZonMw
- Public TitleThe implementation of ColourYourLife in primary care.
- Scientific TitleThe implementation and evaluation of a blended, evidence-based eHealth depression prevention intervention in primary care
- hypothesis
- Healt Condition(s) or Problem(s) studiedDepression
- Inclusion criteriaAll patients that are referred to the eHealth intervention by their general practitioner or practice nurse will be approached for participation in the study. Patients presenting with depressive complaints while not meeting the ICD or DSM diagnostic criteria for depressive disorder, but in whom an imminent onset of the full-blown disorder should be expected, are eligible for the eHealth intervention, as well as patients presenting with mild or moderate manifestations of uncomplicated depressive disorder. In addition, patients must be at least 18 years of age and have Internet access. Patients can participate in the study if they provide written informed consent.
- Exclusion criteriaThere are no additional exclusion criteria for the study.
- mec approval receivedyes
- multicenter trialyes
- randomisedno
- groupParallel
- TypeSingle arm
- Studytypeintervention
- planned startdate 13-mei-2014
- planned closingdate1-nov-2016
- Target number of participants100
- InterventionsThe aim of this study is to design and execute a plan for implementing the eHealth intervention ('ColourYourLife') in primary care centers, and to monitor and evaluate that implementation. Kleurjeleven is an online intervention aimed at reducing depressive symptoms. The intervention consists of 8 modules with texts, exercised, videos and figures, and are followed by a ninth booster session. The intervention is based on cognitive behavioural therapy, and more specific on the Dutch version of the 'Coping with Depression' course. It covers the following topics: psycho-education, cognitive restructuring, behaviour change, and relapse prevention. In the present study, is implemented as guided self-help, i.e. with support from practice nurses.
- Primary outcomeThe primary aim is to evaluate whether the implementation was succesful, indicated by the number of participation practices and trained professionals (who refer to the intervention), the number of referrals, the number of patients actually participating and the level of treatment adherence of patients and professionals.
- Secondary outcomeIt will also be examined which factors determine success or failure of the implementation; which preconditions must be fulfilled in order to successfully implement the intervention; whether professionals and patients are satisfied with the usage of the intervention in primary care; to what degree general practitioners and practice nurses referred patients to the intervention and to what degree patients made use of it. Therefore, data will collected on: demographics, attitude with respect to eHealth, the performance expectancy, effort expectancy, social influence, facilitating and limitating conditions, self efficacy, and intention to use the intervention (based on the UTAUT model of Venkatesh). On patient level, depressive symptoms will be measured as well (at baseline, at 10 weeks after the start and 12 weeks after finishing the intervention). On general practitioner/practice nurse level, factors such as work experience and work situation will be measured in addition to the abovementioned factors.
- TimepointsData are collected before the start of the implementation, during the implementation and after.
- Trial web site
- statusplanned
- CONTACT for SCIENTIFIC QUERIESDr. M. Zijlstra-Vlasveld
- 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
- Publications
- Brief summaryThe aim of this study is to design and execute a plan for implementing the evidence-based eHealth intervention in primary care centers, and to monitor and evaluate that implementation. The eHealth intervention will be guided by practice nurses. Quantitative and qualitative data will be collected among the participating general practitioners, practice nurses and their patients who are referred by them to the intervention. Data are collected before, during and after the implementation. Main questions to be answered are whether the implementation was successful and which factors determine success of the implementation.
- Main changes (audit trail)
- RECORD16-apr-2014 - 5-mei-2014

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