Prevention of psychological problems in older widowed persons by means of a visiting service: A randomized trial
| ISRCTN | ISRCTN17508307 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN17508307 |
| Protocol serial number | ZON-MW 63-224 |
| Sponsor | Trimbos Institute (The Netherlands) |
| Funder | ZON-MW, The Netherlands Organization for Health Research and Development |
- Submission date
- 12/09/2005
- Registration date
- 12/09/2005
- Last edited
- 07/01/2021
- 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
Plain English summary of protocol
Not provided at time of registration
Contact information
Dr S. Onrunst
Scientific
Scientific
Trimbos Institute/Netherlands Institute of Mental Health and Addiction
P.O.Box 725
Utrecht
3500 AS
Netherlands
| Phone | +31 (0)30 2971100 |
|---|---|
| sonrust@trimbos.nl |
Study information
| Primary study design | Interventional |
|---|---|
| Study design | Randomised controlled trial |
| Secondary study design | International |
| Scientific title | Prevention of psychological problems in older widowed persons by means of a visiting service: A randomized trial |
| Study objectives | 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 |
| Ethics approval(s) | Not provided at time of registration |
| Health condition(s) or problem(s) studied | Psychological problems |
| Intervention | 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. |
| Intervention type | Other |
| Primary outcome measure(s) |
1. Mental health |
| Key secondary outcome measure(s) |
1. Quality of life |
| Completion date | 01/05/2007 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Sex | All |
| Target sample size at registration | 350 |
| Total final enrolment | 216 |
| Key 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 |
| Key exclusion criteria | When not met the five inclusion criteria mentioned above, people are excluded. |
| Date of first enrolment | 01/11/2002 |
| Date of final enrolment | 01/05/2007 |
Locations
Countries of recruitment
- Netherlands
Study participating centre
Trimbos Institute/Netherlands Institute of Mental Health and Addiction
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 |
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|---|---|---|---|---|
| Results article | results | 12/06/2008 | 07/01/2021 | Yes | No |
Editorial Notes
07/01/2021: Publication reference and total final enrolment added.
