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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.

ClinicalTrials.gov Identifier: NCT00603421

Recruitment Status : Completed

First Posted : January 29, 2008

Last Update Posted : February 25, 2016

Sponsor:

Information provided by (Responsible Party):

Assistance Publique - Hôpitaux de Paris

Study Description

Brief 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.

Condition or disease	Intervention/treatment	Phase
Borderline Personality Disorder	Other: 24 hour phone line Other: treatment as usual	Not Applicable

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).

Study Design


Study Type :	Interventional (Clinical Trial)
Actual Enrollment :	318 participants
Allocation:	Randomized
Intervention Model:	Parallel Assignment
Masking:	Single (Investigator)
Primary Purpose:	Health Services Research
Official Title:	Effectiveness of a 24 Hour Phone Line on the Rate of Suicide Attempts in Borderline Patients
Study Start Date :	February 2009
Actual Primary Completion Date :	October 2014
Actual Study Completion Date :	December 2014

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Personality Disorders Self-harm Suicide

U.S. FDA Resources

Arms and Interventions

Arm	Intervention/treatment
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
Active Comparator: 2 Patient benefits from treatment as usual	Other: treatment as usual Treatment as usual

Outcome Measures

Primary Outcome Measures :

Rate of suicide attempts [ Time Frame: Annual ]

Secondary Outcome Measures :

rate of self injurious behaviors [ Time Frame: annual ]

Eligibility Criteria

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Ages Eligible for Study:	18 Years to 40 Years (Adult)
Sexes Eligible for Study:	All
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00603421

Locations


France
Hôpital St Anne
Paris, France, 75014
Hopital Cochin Centre de recherche Clinique Paris Centre
Paris, France, 75679

Sponsors and Collaborators

Assistance Publique - Hôpitaux de Paris

Investigators


Principal Investigator:	Alexandra Pham-Scottez, MD	Centre Hospitalier Sainte Anne

More Information


Responsible Party:	Assistance Publique - Hôpitaux de Paris
ClinicalTrials.gov Identifier:	NCT00603421 History of Changes
Other Study ID Numbers:	AOM 05062
First Posted:	January 29, 2008 Key Record Dates
Last Update Posted:	February 25, 2016
Last Verified:	February 2016
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD:	No

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:


Suicide Personality Disorders Borderline Personality Disorder Suicide, Attempted	Self-Injurious Behavior Behavioral Symptoms Mental Disorders

To Top