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The Amager Project: Intervention After Suicide Attempt (Amager)

Primary Purpose

Suicidal Behaviour, Repetition of Suicidal Behaviour

Status
Unknown status
Phase
Not Applicable
Locations
Denmark
Study Type
Interventional
Intervention
OPAC (Outreach, Problem solving, Adherence, Continuity)
Sponsored by
Rigshospitalet, Denmark
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Suicidal Behaviour focused on measuring Suicidal behaviour, Attempted suicide, Self harm, Suicide, Health system contacts, Contacts with health system

Eligibility Criteria

12 Years - undefined (Child, Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • Suicide attempt and self harm

Exclusion Criteria:

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

Sites / Locations

  • Psychiatric Centre Amager, Copenhagen University Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

No Intervention

Arm Label

1

2

Arm Description

Assertive intervention in OPAC-style: Outreach,problem solving,adherence,continuity

Control arm: Treatment as usual

Outcomes

Primary Outcome Measures

Persons repeating a suicidal act

Secondary Outcome Measures

Acts of suicidal behaviour Contacts with health system

Full Information

First Posted
January 12, 2009
Last Updated
January 12, 2009
Sponsor
Rigshospitalet, Denmark
Collaborators
Ministry of Social Affairs, Denmark
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1. Study Identification

Unique Protocol Identification Number
NCT00821756
Brief Title
The Amager Project: Intervention After Suicide Attempt
Acronym
Amager
Official Title
The Amager Project. Intervention After Suicide Attempt: A Randomized Study.
Study Type
Interventional

2. Study Status

Record Verification Date
January 2009
Overall Recruitment Status
Unknown status
Study Start Date
January 2005 (undefined)
Primary Completion Date
August 2008 (Actual)
Study Completion Date
August 2010 (Anticipated)

3. Sponsor/Collaborators

Name of the Sponsor
Rigshospitalet, Denmark
Collaborators
Ministry of Social Affairs, Denmark

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Suicidal Behaviour, Repetition of Suicidal Behaviour
Keywords
Suicidal behaviour, Attempted suicide, Self harm, Suicide, Health system contacts, Contacts with health system

7. Study Design

Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
133 (Actual)

8. Arms, Groups, and Interventions

Arm Title
1
Arm Type
Experimental
Arm Description
Assertive intervention in OPAC-style: Outreach,problem solving,adherence,continuity
Arm Title
2
Arm Type
No Intervention
Arm Description
Control arm: Treatment as usual
Intervention Type
Behavioral
Intervention Name(s)
OPAC (Outreach, Problem solving, Adherence, Continuity)
Intervention Description
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.
Primary Outcome Measure Information:
Title
Persons repeating a suicidal act
Time Frame
One, two and three years
Secondary Outcome Measure Information:
Title
Acts of suicidal behaviour Contacts with health system
Time Frame
One, two and three years

10. Eligibility

Sex
All
Minimum Age & Unit of Time
12 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Suicide attempt and self harm Exclusion Criteria: Severe mental diagnosis (schizophrenia, psychosis, bipolar affective disorder, severe/psychotic depression, severe dementia)
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
August G. Wang, M.D.
Organizational Affiliation
Psychiatric Centre Amager, Copenhagen University Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
Psychiatric Centre Amager, Copenhagen University Hospital
City
Copenhagen S
ZIP/Postal Code
DK-2300
Country
Denmark

12. IPD Sharing Statement

Citations:
PubMed Identifier
19016074
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.
Results Reference
background
PubMed Identifier
21171837
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.
Results Reference
derived

Learn more about this trial

The Amager Project: Intervention After Suicide Attempt

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