My story as informal care-giver: a randomised controlled trial
| ISRCTN | ISRCTN08206786 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN08206786 |
| Protocol serial number | N/A |
| Sponsor | Trimbos-Institute - Netherlands Institute of Mental Health and Addiction (The Netherlands) |
| Funder | The Netherlands Organisation for Health Research and Development (ZonMw) (The Netherlands) |
- 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
Scientific
Trimbos-Instituut
P.O. Box 725
Utrecht
3500 AS
Netherlands
| Phone | +31 (0)30 2971100 |
|---|---|
| ebohlmeijer@trimbos.nl |
Study information
| Primary study design | Interventional |
|---|---|
| Study design | Randomised, multicentre, placebo controlled, parallel group trial |
| Secondary study design | Randomised controlled trial |
| 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(s) |
1. Depressive symptoms |
| Key secondary outcome measure(s) |
No secondary outcome measures |
| Completion date | 31/12/2008 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Sex | Not Specified |
| Target sample size at registration | 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
3500 AS
Netherlands
Results and Publications
| Individual participant data (IPD) Intention to share | No |
|---|---|
| IPD sharing plan summary | Not provided at time of registration |
| IPD sharing plan |
