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
Protocol serial number	METC 2002/137
Sponsor	University Medical Center Groningen (UMCG) (The Netherlands)
Funder	The Netherlands Organisation for Health Research and Development (ZonMw) (The Netherlands)

Prospectively registered

Protocol

Statistical analysis plan

Results

Individual participant data

Plain English summary of protocol

Not provided at time of registration

Dr Marieke de Groot
Scientific

University Medical Center Groningen (UMCG)
Department of Social Psychiatry
P.O. Box 30001
Groningen
9700 RB
Netherlands

Phone	+31 (0)50 3614701
Email	m.h.de.groot@med.umcg.nl

Primary study design	Interventional
Study design	Randomised controlled trial
Secondary study design	Randomised controlled trial
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(s)	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)
Key secondary outcome measure(s)	1. Guilt 2. Relief 3. Satisfaction
Completion date	01/01/2004

Participant type(s)	Patient
Age group	Adult
Sex	All
Target sample size at registration	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

University Medical Center Groningen (UMCG)

Groningen
9700 RB
Netherlands

Individual participant data (IPD) Intention to share	No
IPD sharing plan summary	Not provided at time of registration
IPD sharing plan

Output type	Details	Date created	Date added	Peer reviewed?	Patient-facing?
Results article	Results	12/05/2007		Yes	No