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| Sponsors and Collaborators: |
University of Copenhagen Ministry of Social Affairs |
| Information provided by: | University of Copenhagen |
| ClinicalTrials.gov Identifier: | NCT00700089 |
Purpose
Background
Previous suicide attempts is a high-risk factor with a repetition rate between 12-30 percent. Compliance with after treatment is often poor. A systematic review by Hawton, 1999 states a lack of evidence on psychosocial interventions due to selections bias or statistical power.
Objective
The aim is to investigate if assertive outreach, incorporating hands-on guidance and motivational support of compliance with follow-up treatment after suicide attempts is able to reduce the frequency of non-fatal and fatal suicide acts in a one-year follow-up period.
Method and Design
A randomized, controlled intervention trial in a prospective design. The patients included will be randomized to either standard treatment (n = 120) or intervention treatment (N = 120), representing 6 - 8 assertive outreach contacts with a research nurse after suicide attempts or deliberate self-harm. The outreach contacts are thought of as supporting and guiding home visits towards compliance with after care or follow-up treatment Inclusion criteria Males and females, aged 12 years or older with a recent suicide attempt or act of deliberate self-harm, living independently and not diagnosed with severe mental illness (psychosis, severe dementia)
Outcome
The primary outcome measure is repeated fatal suicidal act (fatal or non fatal)assessed by the Danish Cause of Death Register and the rate of repeated suicide attempts/deliberate self-harm registered in the medical records by the collaborating wards and units in their routine procedure of treating people applying for help in relation to suicidal behavior.
| Condition | Intervention | Phase |
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Suicide, Attempted |
Behavioral: Assertive intervention Other: Standard treatment |
Phase IV |
| MedlinePlus related topics: | Suicide |
| Drug Information available for: | Ethanol |
| Study Type: | Interventional |
| Study Design: | Treatment, Randomized, Single Blind (Investigator), Placebo Control, Parallel Assignment, Efficacy Study |
| Official Title: | AID-Trial:A Randomized Clinical Trial Comparing the Effect on Repeated Self-Harm of Assertive Intervention and Standard Treatment After Deliberate Self-Harm |
| Estimated Enrollment: | 240 |
| Study Start Date: | November 2007 |
| Estimated Study Completion Date: | December 2011 |
| Estimated Primary Completion Date: | December 2010 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
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A: Experimental
The concept is to support and guide the person shortly after the in-hospital treatment for self-injury through a recommended follow-up or after treatment based on assertive principles. The intervention is an indicated prevention strategy targeting people with suicide attempts and deliberate self-harm as a high-risk group. They will be offered 8-20 assertive outreach contacts. The outreach contacts will be home visits focusing on providing support and motivating patients to comply with follow-up treatment.
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Behavioral: Assertive intervention
8-20 assertive contacts after suicide attempt
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B: Placebo Comparator
Standard treatment consists of referral to a range of different treatment modalities depending on the diagnosis and clinical and social condition of the patient. In standard treatment there is no procedure for ensuring that the patient will actually receive the recommended treatment. Patients are often referred to available treatment modalities such as general practitioner, psychological treatment, treatment for alcohol abuse, and most often, the patients are themselves responsible for getting into contact with the treatment to which they are referred.
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Other: Standard treatment
In standard treatment there is no procedure for ensuring that the patient will actually receive the recommended treatment. Patients are often referred to available treatment modalities such as general practitioner, psychological treatment, treatment for alcohol abuse, and most often, the patients are themselves responsible for getting into contact with the treatment to which they are referred.
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Show Detailed Description |
Eligibility
| Ages Eligible for Study: | 12 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Contacts and Locations| Contact: Britt R Morthorst, Nurse | 45-2752-1085 | bmor0004@bbh.regionh.dk |
| Contact: Merete Nordentoft, Dr Med Sc | 45-2060-7552 | mn@dadlnet.dk |
| Denmark | |||||
| Psychiatric Center Bispebjerg | Recruiting | ||||
| Copenhagen, Denmark, 2400 | |||||
| Contact: Merete Nordentoft, Dr Med Sc 45-206-075 52 mn@dadlnet.dk | |||||
| Principal Investigator: Merete Nordentoft, Dr Med Sc | |||||
| University of Copenhagen |
| Ministry of Social Affairs |
| Principal Investigator: | Merete Nordentoft, Dr. Med Sc. | Professor |
More Information
Related Info
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| Responsible Party: | Psychiatric Center Bispebjerg ( Merete Nordentoft ) |
| Study ID Numbers: | AID-trial Copenhagen, Psychiatric Center Bispebjerg |
| First Received: | June 16, 2008 |
| Last Updated: | June 26, 2008 |
| ClinicalTrials.gov Identifier: | NCT00700089 |
| Health Authority: | Denmark: Ethics Committee |
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