Condition category
Mental and Behavioural Disorders
Date applied
28/04/2006
Date assigned
28/04/2006
Last edited
26/04/2007
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Not provided at time of registration

Trial website

Contact information

Type

Scientific

Primary contact

Dr Marieke de Groot

ORCID ID

Contact details

University Medical Center Groningen (UMCG)
Department of Social Psychiatry
P.O. Box 30001
Groningen
9700 RB
Netherlands
+31 (0)50 3614701
m.h.de.groot@med.umcg.nl

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

METC 2002/137

Study information

Scientific title

Acronym

Study hypothesis

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

Approval received from the local ethics committee (ref: METC 2002/137).

Study design

Randomised controlled trial

Primary study design

Interventional

Secondary study design

Randomised controlled trial

Trial setting

Not specified

Trial type

Prevention

Patient information sheet

Condition

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

Phase

Not Specified

Drug names

Primary outcome measures

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 trial start date

01/09/1999

Overall trial end date

01/01/2004

Reason abandoned

Eligibility

Participant 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.

Participant type

Patient

Age group

Adult

Gender

Both

Target number of participants

106

Participant exclusion criteria

1. Severe mental illness
2. Imprisonment of the deceased
3. Lack of Dutch fluency

Recruitment start date

01/09/1999

Recruitment end date

01/01/2004

Locations

Countries of recruitment

Netherlands

Trial participating centre

University Medical Center Groningen (UMCG)
Groningen
9700 RB
Netherlands

Sponsor information

Organisation

University Medical Center Groningen (UMCG) (The Netherlands)

Sponsor details

P.O. Box 30001
Groningen
9700 RB
Netherlands

Sponsor type

University/education

Website

Funders

Funder type

Research organisation

Funder name

The Netherlands Organisation for Health Research and Development (ZonMw) (The Netherlands)

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

Results and Publications

Publication and dissemination plan

Not provided at time of registration

Intention to publish date

Participant level data

Not provided at time of registration

Results - basic reporting

Publication summary

Results in: http://www.ncbi.nlm.nih.gov/entrez/query.fcgi?cmd=retrieve&db=pubmed&list_uids=17449505

Publication citations

  1. Results

    de Groot M, de Keijser J, Neeleman J, Kerkhof A, Nolen W, Burger H, Cognitive behaviour therapy to prevent complicated grief among relatives and spouses bereaved by suicide: cluster randomised controlled trial., BMJ, 2007, 334, 7601, 994, doi: 10.1136/bmj.39161.457431.55.

Additional files

Editorial Notes