Suicidal BehaviourAmagerNCT00821756
The Amager Project: Intervention After Suicide Attempt
A study testing OPAC (Outreach, Problem solving, Adherence, Continuity) in people with Suicidal Behaviour and Repetition of Suicidal Behaviour, run by Copenhagen University Hospital, Rigshospitalet at 1 site in Denmark.
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. Read more about this study
- Who is it for?
- Ages 12 years and older
- Conditions the study is for
- Suicidal Behaviour, Repetition of Suicidal Behaviour
- What is being tested?
- OPAC (Outreach, Problem solving, Adherence, Continuity)
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 133 participants
- Where
- 1 siteDenmark
- Study dates
- Jan 2005to Aug 2010
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 12 years and older
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- Suicide attempt and self harm
Who cannot join
- Severe mental diagnosis (schizophrenia, psychosis, bipolar affective disorder, severe/psychotic depression, severe dementia)
Trial locations and contacts
1 site in 1 country.
Denmark1 site
Psychiatric Centre Amager, Copenhagen University Hospital
Copenhagen S, DK-2300
About this study
Official title: The Amager Project. Intervention After Suicide Attempt: A Randomized Study.
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.
Read more
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.
- Being tested
- OPAC (Outreach, Problem solving, Adherence, Continuity)
- Keywords
- Suicidal behaviour, Attempted suicide, Self harm, Suicide, Health system contacts, Contacts with health system
- Medical subject headings
- Suicide, Attempted, Self-Injurious Behavior, Suicide
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
OPAC (Outreach, Problem solving, Adherence, Continuity)Behavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| 1 | Experimental | Assertive intervention in OPAC-style: Outreach,problem solving,adherence,continuity Receives: Behavioral: OPAC (Outreach, Problem solving, Adherence, Continuity) |
| 2 | No intervention | Control arm: Treatment as usual |
What is being measured
The primary outcome is the main question the study is designed to answer.
Persons repeating a suicidal act
Measured: One, two and three years
Secondary outcomes (1)
Acts of suicidal behaviour Contacts with health system
Measured: One, two and three years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Jan 2009 (estimated)
- Study startJan 2005
- Primary completionAug 2008
- Study completionAug 2010 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Suicidal BehaviourStudies of the same condition, open and under way.
- More trials run by Copenhagen University Hospital, RigshospitaletThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 133 participants (actual)
Sponsor and investigators
- Lead sponsor
- Copenhagen University Hospital, Rigshospitalet
- Sponsor type
- University, hospital or other
- Collaborators
- Ministry of Social Affairs, Denmark
- Investigators
- August G. Wang, M.D., Principal investigator, Psychiatric Centre Amager, Copenhagen University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00821756
- Sponsor's protocol ID
- AH-2005
- Acronym
- Amager
- Status last verified
- Jan 2009
- First submitted
- 12 Jan 2009
- Last updated
- 13 Jan 2009
- Results posted
- No
- Data monitoring committee
- Yes
Publications
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.
PubMed 19016074Hvid 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.
PubMed 21171837
Study at a glance
From the registry record, last updated by the sponsor on 13 Jan 2009. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Amager Project. Intervention After Suicide Attempt: A Randomized Study.
- ClinicalTrials.gov ID
- NCT00821756
- Acronym / sponsor ID
- Amager / AH-2005
- Keywords
- Suicidal behaviour, Attempted suicide, Self harm, Suicide, Health system contacts, Contacts with health system
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 133 participants (actual)
- Lead sponsor
- Copenhagen University Hospital, RigshospitaletUniversity, hospital or other
- Collaborators
- Ministry of Social Affairs, Denmark
- Study start
- Jan 2005
- Primary completion
- Aug 2008 (actual)
- Study completion
- Aug 2010 (estimated)
- First posted
- 13 Jan 2009 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 1 | Experimental | Behavioral: OPAC (Outreach, Problem solving, Adherence, Continuity)Assertive intervention in OPAC-style: Outreach,problem solving,adherence,continuity |
| 2 | No intervention | –Control arm: Treatment as usual |
Who may qualify
- Ages
- 12 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (1 listed)
- Suicide attempt and self harm
Key exclusion criteria (1 listed)
- Severe mental diagnosis (schizophrenia, psychosis, bipolar affective disorder, severe/psychotic depression, severe dementia)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| 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. | Behavioural | 1 |
Primary outcome
Persons repeating a suicidal act
Time frame: One, two and three years
1 secondary outcome
Acts of suicidal behaviour Contacts with health system
Time frame: One, two and three years
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Jan 2009.
- Background: PubMed 19016074Hvid 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.
- Derived from this study: PubMed 21171837Hvid 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.
Related trials for Suicidal Behaviour
Recruiting
Prevention of Suicidal Behavior Through the VIGILANS Protocol: the Restoration of Social Connection Hypothesis
Suicidal Behaviour Disorder
Not yet recruiting
Couple-Based Crisis Safety Planning
Suicidal Ideas, Suicidal Ideation
Active, not recruiting
Social Media and Suicidal Behaviour - Study 1
Suicidal Behaviour
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
August G. Wang, M.D. principal investigator
Psychiatric Centre Amager, Copenhagen University Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing OPAC (Outreach, Problem solving, Adherence, Continuity) in people with Suicidal Behaviour and Repetition of Suicidal Behaviour, run by Copenhagen University Hospital, Rigshospitalet at 1 site in Denmark.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 13 Jan 2009. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Denmark. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Persons repeating a suicidal act (time frame: One, two and three years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00821756, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 Jan 2009; AzTrials last refreshed its copy on 30 Oct 2026.