NCT00821756

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
133

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Jan 2005

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2005

Completed
3.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 1, 2008

Completed
5 months until next milestone

First Submitted

Initial submission to the registry

January 12, 2009

Completed
1 day until next milestone

First Posted

Study publicly available on registry

January 13, 2009

Completed
1.5 years until next milestone

Study Completion

Last participant's last visit for all outcomes

August 1, 2010

Completed
Last Updated

January 13, 2009

Status Verified

January 1, 2009

Enrollment Period

3.6 years

First QC Date

January 12, 2009

Last Update Submit

January 12, 2009

Conditions

Suicidal BehaviourRepetition of Suicidal Behaviour

Keywords

Suicidal behaviourAttempted suicideSelf harmSuicideHealth system contactsContacts with health system

Outcome Measures

Primary Outcomes (1)

  • Persons repeating a suicidal act

    One, two and three years

Secondary Outcomes (1)

  • Acts of suicidal behaviour Contacts with health system

    One, two and three years

Study Arms (2)

1

EXPERIMENTAL

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

Behavioral: OPAC (Outreach, Problem solving, Adherence, Continuity)

2

NO INTERVENTION

Control arm: Treatment as usual

Interventions

OPAC (Outreach, Problem solving, Adherence, Continuity)BEHAVIORAL

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.

1

Eligibility Criteria

Age12 Years+
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • Suicide attempt and self harm

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Psychiatric Centre Amager, Copenhagen University Hospital

Copenhagen S, DK-2300, Denmark

Location

Related Publications (2)

  • 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.

    PMID: 19016074BACKGROUND

  • 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.

    PMID: 21171837DERIVED

MeSH Terms

Conditions

Suicide, AttemptedSelf-Injurious BehaviorSuicide

Condition Hierarchy (Ancestors)

Behavioral SymptomsBehavior

Study Officials

  • August G. Wang, M.D.

    Psychiatric Centre Amager, Copenhagen University Hospital

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER

Study Record Dates

First Submitted

January 12, 2009

First Posted

January 13, 2009

Study Start

January 1, 2005

Primary Completion

August 1, 2008

Study Completion

August 1, 2010

Last Updated

January 13, 2009

Record last verified: 2009-01

Locations

DK(1)