Survivors at risk: a randomised controlled trial of primary prevention of complicated grief among first degree relatives of suicide victims
| ISRCTN | ISRCTN66473618 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN66473618 |
| Secondary identifying numbers | METC 2002/137 |
- Submission date
- 28/04/2006
- Registration date
- 28/04/2006
- Last edited
- 26/04/2007
- 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
Plain English summary of protocol
Not provided at time of registration
Contact information
Dr Marieke de Groot
Scientific
Scientific
University Medical Center Groningen (UMCG)
Department of Social Psychiatry
P.O. Box 30001
Groningen
9700 RB
Netherlands
| Phone | +31 (0)50 3614701 |
|---|---|
| m.h.de.groot@med.umcg.nl |
Study information
| Study design | Randomised controlled trial |
|---|---|
| Primary study design | Interventional |
| Secondary study design | Randomised controlled trial |
| Study setting(s) | Not specified |
| Study type | Prevention |
| Scientific title | |
| Study objectives | A brief (four sessions) nurse-led family focused intervention, based on cognitive behavioral therapy and psycho-education, offered between three and six months following the suicide, prevents depressive and complicated grief symptoms at 13 months bereavement. |
| Ethics approval(s) | Approval received from the local ethics committee (ref: METC 2002/137). |
| Health condition(s) or problem(s) studied | Suicide bereavement, complicated grief |
| Intervention | Brief, nurse-led family-focused four session intervention by trained psychiatric nurses, based on cognitive behavioural therapy and psycho-education versus care as usual (control). |
| Intervention type | Other |
| Primary outcome measure | 1. Depression (Center for Epidemiologic Studies Depression Scale [CESD]) 2. Complicated grief (Inventory of Traumatic Grief [ITG]) 3. Traumatic Grief Evaluation of Response to Loss (TRGR2L) 4. Schedules for Clinical Assessment in Neuropsychiatry (SCAN) |
| Secondary outcome measures | 1. Guilt 2. Relief 3. Satisfaction |
| Overall study start date | 01/09/1999 |
| Completion date | 01/01/2004 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Sex | Both |
| Target number of participants | 106 |
| Key inclusion criteria | Families (first-degree relatives, in-laws and spouses) of suicide victims recruited in the three northern provinces of the Netherlands between 1 September 1999 and 1 January 2002. |
| Key exclusion criteria | 1. Severe mental illness 2. Imprisonment of the deceased 3. Lack of Dutch fluency |
| Date of first enrolment | 01/09/1999 |
| Date of final enrolment | 01/01/2004 |
Locations
Countries of recruitment
- Netherlands
Study participating centre
University Medical Center Groningen (UMCG)
Groningen
9700 RB
Netherlands
9700 RB
Netherlands
Sponsor information
University Medical Center Groningen (UMCG) (The Netherlands)
University/education
University/education
P.O. Box 30001
Groningen
9700 RB
Netherlands
"ROR" |
https://ror.org/03cv38k47 |
|---|
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 |
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|---|---|---|---|---|
| Results article | Results | 12/05/2007 | Yes | No |
