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

Borderline Personality Disorder Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00603421
• Other study ID #: AOM 05062
• Status: Completed
• Phase: N/A
• First received: January 16, 2008
• Last updated: February 24, 2016
• Start date: February 2009
• Est. completion date: December 2014

Study information

• Verified date: February 2016
• Source: Assistance Publique - Hôpitaux de Paris
• Contact: n/a
• Is FDA regulated: No
• Health authority: France: Ministry of Health
• Study type: Interventional

Clinical Trial Summary

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.

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).

Recruitment information / eligibility

• Status: Completed
• Enrollment: 318
• Est. completion date: December 2014
• Est. primary completion date: October 2014
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 40 Years

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Investigator), Primary Purpose: Health Services Research

Related Conditions & MeSH terms

• Borderline Personality Disorder
• Personality Disorders
• Suicide
• Suicide, Attempted

Intervention

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
• treatment as usual
Treatment as usual

Locations

Country	Name	City	State
France	Hopital Cochin Centre de recherche Clinique Paris Centre	Paris
France	Hôpital St Anne	Paris

Sponsors (1)

Lead Sponsor	Collaborator
Assistance Publique - Hôpitaux de Paris

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Rate of suicide attempts		Annual	Yes
Secondary	rate of self injurious behaviors		annual	Yes