The Amager Project: Intervention After Suicide Attempt

Suicidal Behaviour Clinical Trial

— Amager  

Official title:

The Amager Project. Intervention After Suicide Attempt: A Randomized Study.

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT00821756
• Other study ID #: AH-2005
• Status: Active, not recruiting
• Phase: N/A
• First received: January 12, 2009
• Last updated: January 12, 2009
• Start date: January 2005
• Est. completion date: August 2010

Study information

• Verified date: January 2009
• Source: Rigshospitalet, Denmark
• Contact: n/a
• Is FDA regulated: No
• Health authority: Denmark: Danish Dataprotection Agency
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 133
• Est. completion date: August 2010
• Est. primary completion date: August 2008
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 12 Years and older

Eligibility

Inclusion Criteria:

• Suicide attempt and self harm

Exclusion Criteria:

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

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Outcomes Assessor), Primary Purpose: Prevention

Related Conditions & MeSH terms

• Repetition of Suicidal Behaviour
• Suicidal Behaviour
• Suicide
• Suicide, Attempted

Intervention

Behavioral:
• OPAC (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.

Locations

Country	Name	City	State
Denmark	Psychiatric Centre Amager, Copenhagen University Hospital	Copenhagen S

Sponsors (2)

Lead Sponsor	Collaborator
Rigshospitalet, Denmark	Ministry of Social Affairs, Denmark

Country where clinical trial is conducted

Denmark, 

References & Publications (1)

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Persons repeating a suicidal act		One, two and three years	No
Secondary	Acts of suicidal behaviour Contacts with health system		One, two and three years	No