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

This study is ongoing, but not recruiting participants.

Sponsor:

Information provided by (Responsible Party):

Assistance Publique - Hôpitaux de Paris

ClinicalTrials.gov Identifier:

NCT00603421

First received: January 16, 2008

Last updated: June 5, 2013

Last verified: June 2013

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:

MedlinePlus related topics: Personality Disorders Self-harm Suicide

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:	September 2014
Estimated Primary Completion Date:	February 2014 (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

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, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00603421

Locations


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

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:	June 5, 2013
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, Attempted Behavioral Symptoms	Mental Disorders Self-Injurious Behavior Suicide

ClinicalTrials.gov processed this record on March 01, 2015

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