| - candidate number | 1156 |
| - NTR Number | NTR95 |
| - ISRCTN | ISRCTN17508307 |
| - Date ISRCTN created | 12-sep-2005 |
| - date ISRCTN requested | 18-aug-2005 |
| - Date Registered NTR | 28-jul-2005 |
| - Secondary IDs | ZON-MW 63-224 |
| - Public Title | Prevention of psychological problems in older widowed persons by means of a visiting service: A randomized trial. |
| - Scientific Title | Prevention of psychological problems in older widowed persons by means of a visiting service: A randomized trial. |
| - ACRONYM | N/A |
| - hypothesis | Contact with fellow-sufferers, as offered by visiting services to widowed persons with little social support, would show superior effects in improving mental health, quality of life and reducing financial costs to society, compared by a control condition. |
| - Healt Condition(s) or Problem(s) studied | Psychological problems |
| - Inclusion criteria | 1. Widow/widower; 2. Aged 55 years or older; 3. Has lost his/her partner through death 6-12 months earlier; 4. Feels lonely according to the 'Lonelisness Scale'; 5. No mental disorder according to the MINI. |
| - Exclusion criteria | When not met the five inclusion criteria mentioned above, people are excluded. |
| - mec approval received | yes |
| - multicenter trial | no |
| - randomised | yes |
| - masking/blinding | None |
| - control | Active |
| - group | Parallel |
| - Type | 2 or more arms, randomized |
| - Studytype | intervention |
| - planned startdate | 1-nov-2002 |
| - planned closingdate | 1-mei-2007 |
| - Target number of participants | 350 |
| - Interventions | Experimental: visiting service.In the visiting service, recently widowed persons are offered to hold supportive one-to-one talks with trained fellow-sufferers. The objective is to provide social support. The volunteers make maximally 10 home visits, spread out over a one-year period. Control condition: respondents in the control condition are offered a brochure about the prevention of depression. These respondents are free to seek help elsewhere on their own initiative. |
| - Primary outcome | 1. Mental health; 2. Cost-effectiveness. |
| - Secondary outcome | 1. Quality of life; 2. Grief process; 3. Mastery; 4. Loneliness. |
| - Timepoints | N/A |
| - Trial web site | N/A |
| - status | inclusion stopped: follow-up |
| - CONTACT FOR PUBLIC QUERIES | Drs. S. Onrunst |
| - CONTACT for SCIENTIFIC QUERIES | Dr. G. Willemse |
| - Sponsor/Initiator | Trimbos-institute - Netherlands Institute of Mental Health and Addiction |
| - Funding (Source(s) of Monetary or Material Support) | ZON-MW, The Netherlands Organization for Health Research and Development |
| - Publications | N/A |
| - Brief summary | The loss of the partner through death is a major risk factor for developing serious psychological problems. A promising intervention aimed at preventing psychological problems in older widowed persons are visiting services, developed in the USA (Widow-for-Widow program). This trial is aimed at establishing whether this program is also effective in the Netherlands. Respondents are assigned at random to the experimental group (visiting service) or to a control group (no visiting service; brochure about the prevention of depression) and examined at the start of the intervention, after six months, 1 year and 2 years. Outcome measures are mental health, cost-effectiveness, quality of life, loneliness and process of grief. |
| - Main changes (audit trail) | |
| - RECORD | 28-jul-2005 - 29-nov-2009 |
- Indien u gegevens wilt toevoegen of veranderen, kunt u een mail sturen naar nederlands@trialregister.nl