- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00821756
The Amager Project: Intervention After Suicide Attempt (Amager)
The Amager Project. Intervention After Suicide Attempt: A Randomized Study.
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.
Study Overview
Status
Intervention / Treatment
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
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-
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Copenhagen S, Denmark, DK-2300
- Psychiatric Centre Amager, Copenhagen University Hospital
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
- Suicide attempt and self harm
Exclusion Criteria:
- Severe mental diagnosis (schizophrenia, psychosis, bipolar affective disorder, severe/psychotic depression, severe dementia)
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Prevention
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: 1
Assertive intervention in OPAC-style: Outreach,problem solving,adherence,continuity
|
Assertive outreach immediately after the suicide attempt with about 8 home visits plus contact by telephone, phone messages, e-mails.
Duration of intervention 6 months.
|
No Intervention: 2
Control arm: Treatment as usual
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Persons repeating a suicidal act
Time Frame: One, two and three years
|
One, two and three years
|
Secondary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Acts of suicidal behaviour Contacts with health system
Time Frame: One, two and three years
|
One, two and three years
|
Collaborators and Investigators
Sponsor
Collaborators
Investigators
- Principal Investigator: August G. Wang, M.D., Psychiatric Centre Amager, Copenhagen University Hospital
Publications and helpful links
General Publications
- 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.
- 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.
Study record dates
Study Major Dates
Study Start
Primary Completion (Actual)
Study Completion (Anticipated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Estimate)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- AH-2005
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