Contact information
Type
Scientific
Primary contact
Dr Ernst Bohlmeijer
ORCID ID
Contact details
Trimbos-Instituut
P.O. Box 725
Utrecht
3500 AS
Netherlands
+31 (0)30 2971100
ebohlmeijer@trimbos.nl
Additional identifiers
EudraCT number
ClinicalTrials.gov number
Protocol/serial number
N/A
Study information
Scientific title
Acronym
Study hypothesis
The new preventive intervention will lead to a significant decrease in psychological problems and perceived stress, an improvement in the quality of life of the informal care-givers as compared with a waiting list control group.
Ethics approval
Ethics approval received from the local ethics committee (METIGG kamer Noord) on the 23rd January 2007.
Study design
Randomised, multicentre, placebo controlled, parallel group trial
Primary study design
Interventional
Secondary study design
Randomised controlled trial
Trial setting
Not specified
Trial type
Quality of life
Patient information sheet
Condition
Informal care-givers, prevention, depression, burnout, stress
Intervention
The Informal care-givers in Balance course consists of eight two-hour sessions and is designed for adult children who provide structural care for a parent in need of care and are under high perceived stress as a result. At the first three sessions, the participants learn to interview their own parent according to the life review method. Starting at the fourth session of the course, the perspective shifts to the informal care-givers own life. The informal care-givers focus on the meaning and effects, especially undesirable ones, of the informal care on their lives and on the balance they would like to establish in their lives in accordance with the life review method. The possibilities are addressed for introducing a better balance.
Intervention type
Other
Phase
Not Specified
Drug names
Primary outcome measures
1. Depressive symptoms
2. Perceived stress
3. Quality of life
Outcomes will be measured at:
T0: one week before start of intervention
T1: after three months (directly after intervention)
T2: after six month (three months after intervention)
Secondary outcome measures
No secondary outcome measures
Overall trial start date
01/09/2007
Overall trial end date
31/12/2008
Reason abandoned
Eligibility
Participant inclusion criteria
Adults above the age of eighteen who provide informal care for a parent and feel they are under stress as a result.
Participant type
Patient
Age group
Adult
Gender
Not Specified
Target number of participants
200
Participant exclusion criteria
1. The parent of the informal care-provider is no longer able to take part in the life review, e.g. because of having severe dementia
2. The health situation of the parent or informal caregiver requires acute assistance
Recruitment start date
01/09/2007
Recruitment end date
31/12/2008
Locations
Countries of recruitment
Netherlands
Trial participating centre
Trimbos-Instituut
Utrecht
3500 AS
Netherlands
Sponsor information
Organisation
Trimbos-Institute - Netherlands Institute of Mental Health and Addiction (The Netherlands)
Sponsor details
P.O. Box 725
Utrecht
3500 AS
Netherlands
+31 (0)30 2971100
info@trimbos.nl
Sponsor type
Research organisation
Website
Funders
Funder type
Research organisation
Funder name
The Netherlands Organisation for Health Research and Development (ZonMw) (The Netherlands)
Alternative name(s)
Funding Body Type
Funding Body Subtype
Location
Results and Publications
Publication and dissemination plan
Not provided at time of registration
Intention to publish date
Participant level data
Not provided at time of registration
Results - basic reporting
Publication summary