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Sponsors and Collaborators: |
Rigshospitalet, Denmark Ministry of Social Affairs, Denmark |
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Information provided by: | Rigshospitalet, Denmark |
ClinicalTrials.gov Identifier: | NCT00821756 |
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.
Condition | Intervention |
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Suicidal Behaviour Repetition of Suicidal Behaviour |
Behavioral: OPAC (Outreach, Problem solving, Adherence, Continuity) |
Study Type: | Interventional |
Study Design: | Prevention, Randomized, Single Blind (Outcomes Assessor), Active Control, Parallel Assignment, Efficacy Study |
Official Title: | The Amager Project. Intervention After Suicide Attempt: A Randomized Study. |
Enrollment: | 133 |
Study Start Date: | January 2005 |
Estimated Study Completion Date: | August 2010 |
Primary Completion Date: | August 2008 (Final data collection date for primary outcome measure) |
Arms | Assigned Interventions |
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1: Experimental
Assertive intervention in OPAC-style: Outreach,problem solving,adherence,continuity
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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.
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2: No Intervention
Control arm: Treatment as usual
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Ages Eligible for Study: | 12 Years and older |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Denmark | |
Psychiatric Centre Amager, Copenhagen University Hospital | |
Copenhagen S, Denmark, DK-2300 |
Principal Investigator: | August G. Wang, M.D. | Psychiatric Centre Amager, Copenhagen University Hospital |
Responsible Party: | Psychiatric Centre Amager, Copenhagen, Denmark ( August G. Wang ) |
Study ID Numbers: | AH-2005 |
Study First Received: | January 12, 2009 |
Last Updated: | January 12, 2009 |
ClinicalTrials.gov Identifier: | NCT00821756 |
Health Authority: | Denmark: Danish Dataprotection Agency |
Suicidal behaviour Attempted suicide Self harm |
Suicide Health system contacts Contacts with health system |
Suicide, Attempted Suicide Behavioral Symptoms Self-Injurious Behavior |