Clinical trial NCT00821756: The Amager Project: Intervention After Suicide Attempt
Official title: The Amager Project. Intervention After Suicide Attempt: A Randomized Study.
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Suicidal Behaviour
Repetition of Suicidal Behaviour
Keywords: Suicidal behaviour
Attempted suicide
Self harm
Suicide
Health system contacts
Contacts with health system
Lead sponsor: Rigshospitalet, Denmark
Sponsor class: OTHER
Collaborators: name: Ministry of Social Affairs, Denmark
First posted: 2009-01-13
Enrollment: 133
Sex: ALL
Minimum age (years): 12
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: Background:

Repetition rate after a suicide attempt and self harm is very high, about 12-30 percent. Studies, reviewed by Hawton, 1999 show a lack of evidence for psychosocial interventions. Compliance with aftercare is also often very poor.

Objective:

Inspired by the Norwegian Baerum project, the aim is to study if active, assertive outreach, seeking contact, talking about problem solution, motivate to comply to other appointments, will reduce repetition of suicidal acts in the following years.

Methods:

The design is a prospective randomized, controlled trial. The patients (immediately after a suicide attempt or deliberate self harm)) included are randomized to intervention or standard (treatment as usual), aiming at at least 60 persons in each arm. The intervention is carried out through research nurses with about 8 home visits, phone contact, phone messaging, e-mails.Included are persons 12 years of age and older, danish speaking without translator and without diagnoses of severe mental illness (schizophrenia, bipolar illness, mania and severe/psychotic depression) or severe dementia.

Results:

Outcome is measured by repetition of suicidal act (suicide attempt, self harm or completed suicide)as recorded in medical records and by the Danish Cause of Death Register. Repetition measured by persons and by acts throughout 1 year, 2 and 3 years periods. Additional outcome is number and character of health system contacts.


Eligibility criteria: Inclusion Criteria:

* Suicide attempt and self harm

Exclusion Criteria:

* Severe mental diagnosis (schizophrenia, psychosis, bipolar affective disorder, severe/psychotic depression, severe dementia)

Primary outcomes:
measure: Persons repeating a suicidal act
timeFrame: One, two and three years
Secondary outcomes:
measure: Acts of suicidal behaviour Contacts with health system
timeFrame: One, two and three years
Other outcomes:
Locations:
city: Copenhagen S
country: Denmark
facility: Psychiatric Centre Amager, Copenhagen University Hospital
Study officials:
affiliation: Psychiatric Centre Amager, Copenhagen University Hospital
name: August G. Wang, M.D.
role: PRINCIPAL_INVESTIGATOR
References:
citation: Hvid M, Wang AG. Preventing repetition of attempted suicide--I. Feasibility (acceptability, adherence, and effectiveness) of a Baerum-model like aftercare. Nord J Psychiatry. 2009;63(2):148-53. doi: 10.1080/08039480802423022.
citation: Hvid M, Vangborg K, Sorensen HJ, Nielsen IK, Stenborg JM, Wang AG. Preventing repetition of attempted suicide--II. The Amager project, a randomized controlled trial. Nord J Psychiatry. 2011 Oct;65(5):292-8. doi: 10.3109/08039488.2010.544404. Epub 2010 Dec 20.