The e-Mental Health intervention has a positive effect on psychological well-being, feelings of burden and perceived health of family caregivers of people with dementia. This effect will last for several months after finishing the intervention.
ID
Bron
Verkorte titel
Aandoening
Depression, depressive symptoms, family caregivers, caregiver burden, dementia, psychological intervention, e-Mental Health.
Depressie, depressieve klachten, mantelzorg, familieleden, belasting, dementie, psychologische behandeling, e-Mental Health.
Ondersteuning
Onderzoeksproduct en/of interventie
Uitkomstmaten
Primaire uitkomstmaten
Depressive symtoms as measured by the CES-D.
Achtergrond van het onderzoek
INTRODUCTION
‘Dementiedebaas.nl’ (or in English ‘Mastery over Dementia’) is a recently developed internet course for family caregivers of people with dementia under the guidance of a psychologist. The intervention is focused on the empowerment of family caregivers with the aim to improve their psychological well-being in general and reduce their depressive symptoms in particular. Family caregivers were closely involved in the development.
AIM
The aim of the proposed study is to evaluate the (cost)effectiveness of ‘Dementiedebaas.nl’. Research questions are: 1a. Will the intervention generate superior health gains over care-as-usual in terms of a clinically significant change in depressive symptoms, symptoms of anxiety and feelings of burden? 1b. And will these effects be maintained up to 6 months after the intervention? 2. Will the intervention be cost-effective in comparison with “care-as-usual” for QALYs gained?
INTERVENTION
Mastery over Dementia focuses on assisting caregivers to help themselves in preventing depressive symptoms as much as possible under the guidance of a coach. After a course consisting of 8 sessions and a booster session, ongoing forum participation and free access to the course and their file is offered. Caregivers can be reached in an early stage of the care giving process, including those who have not sought help for the person with dementia yet. The intervention incorporates elements of psycho-education, cognitive behavioral therapy, problem solving therapy, relaxation therapy and assertiveness training. Interactive feedback is given by a coach.
DESIGN
The study is a pragmatic randomized controlled trial with two parallel groups. The control group will receive bulletins with practical information via mail at regular intervals. Measurements will be conducted in both conditions at baseline (T=0), after the fourth lesson or bulletin (T=1) and after the ninth lesson or bulletin (T=2). Maximum time interval between T0 and T2 is set at 26 weeks. The intervention group will receive prolonged measurements at 3 and 6 months after T2 to monitor effect maintenance over time.
OUTCOMES
The primary outcome is depressive symptoms. Secondary outcomes are symptoms of anxiety, feelings of competencies, self-perceived pressure from informal care and health-related quality of life.
ANALYSES
Analysis will be conducted following the intention-to-treat principle. Missing values on T1 and T2 because of drop-out will be imputed on the basis of regression analysis. Multivariate linear regression analysis will be used to answer research question 1a. Generalized estimated equations (GEE) analysis will be conducted to answer research question 1b. Research question 2 will be answered by using costs utility analysis for a period of six months.
Doel van het onderzoek
The e-Mental Health intervention has a positive effect on psychological well-being, feelings of burden and perceived health of family caregivers of people with dementia. This effect will last for several months after finishing the intervention.
Onderzoeksopzet
Baseline, after 4 lessons/bulletins, after finishing the intervention (both experimental and control group). Experimental group again 3 months and 6 months after finishing the intervention.
Onderzoeksproduct en/of interventie
The experimental group receives an innovative e-Mental Health intervention, called ‘Dementie de Baas’ (‘Mastery over Dementia’). The intervention consist of 8 lessons and a booster session (follow-up). Working principles are psycho education, cognitive behavioral therapy, problem solving behavior, assertiveness training and relaxation therapy. Participants are in contact with a professional counselor (digital coach) who gives them feedback. The control group receives a minimal intervention. The participants will receive a serie of information bulletins sent every two weeks by e-mail. There is no contact with a professional counsellor.
Publiek
P.O. Box 725
A.M. Pot
Utrecht 3500 AS
The Netherlands
ampot@trimbos.nl
Wetenschappelijk
P.O. Box 725
A.M. Pot
Utrecht 3500 AS
The Netherlands
ampot@trimbos.nl
Belangrijkste voorwaarden om deel te mogen nemen (Inclusiecriteria)
(1) informed consent given; (2) insufficient knowledge or computer skills; (3) depressive symptoms in specific range (CES-D score: 12-26).
Belangrijkste redenen om niet deel te kunnen nemen (Exclusiecriteria)
(1) severe psychiatric problems for which immediate treatment or referral is needed; (2) current treatment for psychiatric problems; (3) suidical thoughts.
Opzet
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In overige registers
Register | ID |
---|---|
NTR-new | NL1934 |
NTR-old | NTR2051 |
CCMO | NL27434.097.09 |
ISRCTN | ISRCTN wordt niet meer aangevraagd. |
OMON | NL-OMON33462 |