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Effectiveness of a 24 Hour Phone Line on the Rate of Suicide Attempts in Borderline Patients

This study is currently recruiting participants.
Verified July 2012 by Assistance Publique - Hôpitaux de Paris
Sponsor:
Information provided by (Responsible Party):
Assistance Publique - Hôpitaux de Paris
ClinicalTrials.gov Identifier:
NCT00603421
First received: January 16, 2008
Last updated: July 25, 2012
Last verified: July 2012
History of Changes
  Purpose

This randomized multicentric clinical trial assesses the effectiveness of 24 hour phone line on the rate of suicide attempts and self-injurious behaviors in borderline patients.


Condition Intervention
Borderline Personality Disorder
 Other: 24 hour phone line
Other: treatment as usual

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Investigator)
Primary Purpose: Health Services Research
Official Title: Effectiveness of a 24 Hour Phone Line on the Rate of Suicide Attempts in Borderline Patients

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Assistance Publique - Hôpitaux de Paris:

Primary Outcome Measures:
  • Rate of suicide attempts [ Time Frame: Annual ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • rate of self injurious behaviors [ Time Frame: annual ] [ Designated as safety issue: Yes ]

Estimated Enrollment: 600
Study Start Date: February 2009
Estimated Study Completion Date: April 2014
Estimated Primary Completion Date: February 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: 1
Patient benefits from treatment as usual plus access to a crisis 24 hour phone line.
 Other: 24 hour phone line
24 hour phone line is available as soon as the patient himself feels necessary. This phone line is supported by professionals of mental health, all specialised in borderline personality disorder
Other Name: 24 hour phone line
Active Comparator: 2
Patient benefits from treatment as usual
 Other: treatment as usual
Treatment as usual
Other Name: treatment as usual

Detailed Description:

Borderline personality disorder is very frequent among psychiatric populations, and chronic suicidality is a major problem in clinical practice with borderline patients. In a lot of countries, suicide prevention centers are available, but most of these centers are not supervised by professionals of mental health, and none is specifically oriented to the borderline population.

The main goal of this study is to assess the effectiveness of a 24 hour crisis phone line on the rate of suicide attempts in a clinical population of borderline patients (the effectiveness of this phone line access on the rate of self-injurious behaviours will also be studied).

In this multicentric controlled trial, 600 borderline patients (men or women, in or out-patients, between 18 and 40 years-old) are randomized in two arms :

  • one with treatment as usual
  • one with treatment as usual, PLUS one year of access to a 24 hour crisis phone line (with a team of psychiatrists specialized in borderline personality disorder).

All patients are assessed with standardized instruments (interviewers are blind to the patient's status), at entry (T1) and one year later (T2).

  Eligibility

Ages Eligible for Study:   18 Years to 40 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • 18 to 40 years old
  • in or out-patient in one of the recruiting center
  • men or women
  • with a borderline personality disorder
  • written informed consent

Exclusion Criteria:

  • inferior to 18 or superior to 40 years old
  • schizophrenia
  • severe somatic disorder
  • participation refusal
  • participation to another interventional study
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00603421

Contacts
Contact: Alexandra Pham-Scottez, MD 0033145658918 a.pham@ch-sainte-anne.fr
Contact: Julien - Daniel Guelfi, MD, PhD 0033145658572 jd.guelfi@ch-sainte-anne.fr

Locations
France
Hôpital St Anne Recruiting
Paris, France, 75014
Contact: Alexandra Pham-Scottez, MD     0033145658918     a.pham@ch-sainte-anne.fr    
Hopital Cochin Centre de recherche Clinique Paris Centre Not yet recruiting
Paris, France, 75679
Contact: Alexandra Pham-Scottez, MD, PhD     0033145658918     a.pham@ch-sainte-anne.fr    
Contact: Laurence Lecomte, MD, PhD     ++33171196494     laurence.lecomte@nck.aphp.fr    
Sponsors and Collaborators
Assistance Publique - Hôpitaux de Paris
Investigators
Principal Investigator: Alexandra Pham-Scottez, MD Centre Hospitalier Sainte Anne
  More Information

No publications provided

Responsible Party: Assistance Publique - Hôpitaux de Paris
ClinicalTrials.gov Identifier: NCT00603421     History of Changes
Other Study ID Numbers: AOM 05062
Study First Received: January 16, 2008
Last Updated: July 25, 2012
Health Authority: France: Ministry of Health

Keywords provided by Assistance Publique - Hôpitaux de Paris:
borderline personality disorder
suicide
suicidality
suicide attempt
suicidal behavior
 self-injurious behavior
self-harm behavior
suicide prevention center
telephone intervention

Additional relevant MeSH terms:
Borderline Personality Disorder
Personality Disorders
Suicide
Suicide, Attempted
 Mental Disorders
Self-Injurious Behavior
Behavioral Symptoms

ClinicalTrials.gov processed this record on May 19, 2013