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

Study Description

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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

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

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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

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

Arms and Interventions

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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

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

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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Primary Outcome Measures :

1. Rate of suicide attempts [ Time Frame: Annual ]

Secondary Outcome Measures :

1. rate of self injurious behaviors [ Time Frame: annual ]

Eligibility Criteria

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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

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

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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

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

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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations 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
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