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Clinical Trials/NCT00821756
NCT00821756UnknownNot Applicable

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

Rigshospitalet, Denmark2 sites in 1 country133 target enrollmentStarted: January 2005Last updated:
Conditions

Trial Snapshot

Phase
Not Applicable
Enrollment
133
Locations
2
Primary Endpoint
Persons repeating a suicidal act

Study Overview

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.

Study Design

Study Type
Interventional
Allocation
Randomized
Intervention Model
Parallel
Primary Purpose
Prevention
Masking
Single (Outcomes Assessor)

Eligibility Criteria

Ages
12 Years to — (Child, Adult, Older Adult)
Sex
All
Accepts Healthy Volunteers
No

Inclusion Criteria

  • Suicide attempt and self harm

Exclusion Criteria

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

Outcomes

Primary Outcomes

Persons repeating a suicidal act

Time Frame: One, two and three years

Secondary Outcomes

  • Acts of suicidal behaviour Contacts with health system(One, two and three years)

Investigators

Sponsor Class
Other

Study Sites (2)

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