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| Sponsors and Collaborators: |
Assistance Publique - Hôpitaux de Paris Centre Hospitalier St Anne |
|---|---|
| Information provided by: | Assistance Publique - Hôpitaux de Paris |
| ClinicalTrials.gov Identifier: | NCT00603421 |
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: | Health Services Research, Randomized, Single Blind (Investigator), Active Control, Parallel Assignment, Safety/Efficacy Study |
| Official Title: | Effectiveness of a 24 Hour Phone Line on the Rate of Suicide Attempts in Borderline Patients |
| Estimated Enrollment: | 600 |
| Study Start Date: | November 2008 |
| Estimated Study Completion Date: | December 2011 |
| Estimated Primary Completion Date: | November 2011 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
1: Experimental
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
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2: Active Comparator
Patient benefits from treatment as usual
|
Other: treatment as usual
Treatment as usual
|
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 :
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 |
Inclusion Criteria:
Exclusion Criteria:
Contacts and Locations| 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 |
| France | |
| Hôpital St Anne | |
| Paris, France, 75014 | |
| Hopital Cochin Centre de recherche Clinique Paris Centre | |
| Paris, France, 75679 | |
| Principal Investigator: | Alexandra Pham-Scottez, MD | Centre Hospitalier Sainte Anne |
More Information
| Responsible Party: | Department Clinical Research of Developpement ( François BASSOMPIERRE ) |
| Study ID Numbers: | AOM 05062 |
| Study First Received: | January 16, 2008 |
| Last Updated: | October 24, 2008 |
| ClinicalTrials.gov Identifier: | NCT00603421 |
| Health Authority: | France: Ministry of Health |
|
borderline personality disorder suicide suicidality suicide attempt suicidal behavior |
self-injurious behavior self-harm behavior suicide prevention center telephone intervention |
|
Suicide, Attempted Mental Disorders Suicide Borderline Personality Disorder |
Behavioral Symptoms Self-Injurious Behavior Personality Disorders |
