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van CCT (UK)

van CCT (UK)

E-care 4 caregivers

- candidate number22402
- NTR NumberNTR5268
- ISRCTNISRCTN no longer applicable
- Date ISRCTN created
- date ISRCTN requested
- Date Registered NTR30-jun-2015
- Secondary IDsWC2015-028 EMGO+ institute
- Public TitleE-care 4 caregivers
- Scientific TitleE-care 4 caregivers; an online, self-management intervention for non-professional caregivers caring for depressed patients; a pilot RCT
- ACRONYMNot applicable
- hypothesisThis pilot intervention has two main hypotheses: 1) The online self-management course for the non-professional caregiver of a depressive patient is accessible and feasible; and 2), The online self-management course will increase mental resilience and self-reliance, improve quality of life, prevents and/or decreases subjective experienced burden and psychological symptoms in the non-professional caregiver (depression, anxiety and stress).
- Healt Condition(s) or Problem(s) studiedPsychological problems
- Inclusion criteriaBeing an informal (not necessarily the principal) caregiver for a person with depressive symptoms, minimum age of 18 years, Dutch’ proficiency, access to the internet and providing informed consent.
- Exclusion criteriaProfessional caregivers
- mec approval receivedyes
- multicenter trialno
- randomisedyes
- masking/blindingNone
- control[default]
- groupParallel
- Type2 or more arms, randomized
- Studytypeintervention
- planned startdate 1-sep-2015
- planned closingdate1-dec-2015
- Target number of participants70
- InterventionsIntervention group: online intervention based on CBT principles and psychoeducation, waitlist control group.
- Primary outcomePsychological stress as measured by the Kessler-10
- Secondary outcomeSubjective experienced burden as measured by ZARIT-12. Depressive symptoms, measured by Kessler-10. Anxiety symptoms as measured by GAD-7. Quality of life, measured by EuroQol. Experienced control over the situation, measured by the Dutch version of the Mastery Questionnaire. User-friendliness of the online intervention, measured by the System Usability Scale. Evaluation of the online intervention, its applicability and its user-friendliness as assessed by participants in a qualitative telephone interview.
- TimepointsThere will be a pre-and a post-test measurement, using the following questionnaires: Kessler-10, Generalized Anxiety Disorder scale, EUROQOOL, Pearlin Mastery Scale, Zarit Burden Interview and the System Usability Scale. There will also be a qualitative semi-structured telephone interview post-intervention.
- Trial web site
- statusinclusion stopped: follow-up
- Sponsor/Initiator Vrije Universiteit Amsterdam, Depression Association (Depressie Vereniging)
- Funding
(Source(s) of Monetary or Material Support)
Fonds Psychische Gezondheid, Fonds Nuts-Ohra, VGB fonds
- PublicationsNot applicable
- Brief summaryBackground: Informal caregivers are highly important in everyday life for depressed patients. Yet, informal caregivers experience more overburdening, stress- and anxiety symptoms. Methods and design: An online self-management intervention will be developed and studied in a pilot-RCT (N=40). In stage one, the intervention will be developed using results from a literature study and two focus groups (professionals and ‘experts by experience’). In stage two, participants will be recruited and randomly assigned to one of two conditions: experimental and waitlist control group. Participants will be assessed at baseline and post-test. Primary outcome measure is subjective experienced burden. Secondary outcome measures are psychological stress, depression, anxiety and quality of life. A qualitative analysis will be performed post-intervention assessing user-friendliness and feasibility satisfaction. Discussion: This intervention could potentially benefit informal caregivers as well as patients and professionals indirectly. It could also lead to a more comprehensive healthcare structure around depressed people.
- Main changes (audit trail)
- RECORD30-jun-2015 - 28-okt-2015

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