| - candidate number | 2583 |
| - NTR Number | NTR972 |
| - ISRCTN | ISRCTN08206786 |
| - Date ISRCTN created | 30-mei-2007 |
| - date ISRCTN requested | 22-mei-2007 |
| - Date Registered NTR | 15-mei-2007 |
| - Secondary IDs | - |
| - Public Title | My story as informal care-giver: a randomized controlled trial |
| - Scientific Title | The effects of a new intervention aiming at prevention of psychological distress with informal caregivers. |
| - ACRONYM | |
| - 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. |
| - Healt Condition(s) or Problem(s) studied | Depression, Burnout , Prevention, Informal care-givers |
| - Inclusion criteria | Adults above the age of eighteen who provide informal care for a parent and feel they are under stress as a result. |
| - 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; |
| - mec approval received | yes |
| - multicenter trial | yes |
| - randomised | yes |
| - masking/blinding | None |
| - control | Placebo |
| - group | Parallel |
| - Type | - |
| - Studytype | intervention |
| - planned startdate | 1-sep-2007 |
| - planned closingdate | 31-dec-2008 |
| - Target number of participants | 200 |
| - Interventions | 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 |
| - Primary outcome | 1. Depressive symptoms; 2. Perceived stress; 3. Quality of life |
| - Secondary outcome | - |
| - Timepoints | |
| - Trial web site | - |
| - status | planned |
| - CONTACT FOR PUBLIC QUERIES | Ernst Bohlmeijer |
| - CONTACT for SCIENTIFIC QUERIES | Ernst Bohlmeijer |
| - Sponsor/Initiator | Trimbos-institute - Netherlands Institute of Mental Health and Addiction, De Geestgronden |
| - Funding (Source(s) of Monetary or Material Support) | ZON-MW, The Netherlands Organization for Health Research and Development |
| - Publications | - |
| - Brief summary | Approximately 750,000 people provide informal care in the Netherlands for more than three months and more than eight hours a week. These informal care-givers run a high risk of psychological problems such as depression or burnout. At the moment, however, no preventive interventions with proven effectiveness are available to informal care-givers in the Netherlands. On the basis of a scientific theoretical model that explains the development of psychological problems among informal care-givers, a new preventive intervention – the informal care-givers in Balance course - has been developed for adult children who provide informal care for their parents. The life review method, a systematic evaluation of one’s own life, plays a central role in the intervention. This method is being used for the first time to address the problems of informal care-givers. An initial regional pilot project demonstrates the positive result of the intervention, i.e. a significant decrease in the perceived stress of informal care-givers. The proposal is to now develop the intervention nation-wide and on a larger scale and to more comprehensively examine the effects. |
| - Main changes (audit trail) | |
| - RECORD | 15-mei-2007 - 5-jun-2007 |
- Indien u gegevens wilt toevoegen of veranderen, kunt u een mail sturen naar nederlands@trialregister.nl