My story as informal care-giver: a randomised controlled trial

ISRCTN	ISRCTN08206786
DOI	https://doi.org/10.1186/ISRCTN08206786
Secondary identifying numbers	N/A

Submission date: 30/05/2007
Registration date: 30/05/2007
Last edited: 22/08/2007

Recruitment status: No longer recruiting
Overall study status: Completed
Condition category: Mental and Behavioural Disorders

Prospectively registered

Protocol

Statistical analysis plan

Results

Individual participant data

Record updated in last year

Plain English summary of protocol

Not provided at time of registration

Contact information

Dr Ernst Bohlmeijer
Scientific

Trimbos-Instituut
P.O. Box 725
Utrecht
3500 AS
Netherlands

Phone	+31 (0)30 2971100
Email	ebohlmeijer@trimbos.nl

Study information

Study design	Randomised, multicentre, placebo controlled, parallel group trial
Primary study design	Interventional
Secondary study design	Randomised controlled trial
Study setting(s)	Not specified
Study type	Quality of life
Scientific title
Study objectives	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(s)	Ethics approval received from the local ethics committee (METIGG kamer Noord) on the 23rd January 2007.
Health condition(s) or problem(s) studied	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
Primary outcome measure	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 study start date	01/09/2007
Completion date	31/12/2008

Eligibility

Participant type(s)	Patient
Age group	Adult
Sex	Not Specified
Target number of participants	200
Key inclusion criteria	Adults above the age of eighteen who provide informal care for a parent and feel they are under stress as a result.
Key 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
Date of first enrolment	01/09/2007
Date of final enrolment	31/12/2008

Locations

Countries of recruitment

Netherlands

Study participating centre

Trimbos-Instituut

Utrecht
3500 AS
Netherlands

Sponsor information

Trimbos-Institute - Netherlands Institute of Mental Health and Addiction (The Netherlands)
Research organisation

P.O. Box 725
Utrecht
3500 AS
Netherlands

Phone	+31 (0)30 2971100
Email	info@trimbos.nl
Website	http://www.trimbos.nl/default37.html
"ROR"	https://ror.org/02amggm23

Funders

Funder type

Research organisation

The Netherlands Organisation for Health Research and Development (ZonMw) (The Netherlands)

No information available

Results and Publications

Intention to publish date
Individual participant data (IPD) Intention to share	No
IPD sharing plan summary	Not provided at time of registration
Publication and dissemination plan	Not provided at time of registration
IPD sharing plan