Effectiveness of a 24 Hour Phone Line on the Rate of Suicide Attempts in Borderline Patients
This study has been completed.
Sponsor:
Assistance Publique - Hôpitaux de Paris
Information provided by (Responsible Party):
Assistance Publique - Hôpitaux de Paris
ClinicalTrials.gov Identifier:
NCT00603421
First received: January 16, 2008
Last updated: February 24, 2016
Last verified: February 2016
- Full Text View
- Tabular View
- No Study Results Posted
- Disclaimer
- How to Read a Study Record
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:
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 ]
| Enrollment: | 318 |
| Study Start Date: | February 2009 |
| Study Completion Date: | December 2014 |
| Primary Completion Date: | October 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
|
|
Active Comparator: 2
Patient benefits from treatment as usual
|
Other: treatment as usual
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 (Adult) |
| 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
Please refer to this study by its ClinicalTrials.gov identifier: 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 |
| Study First Received: | January 16, 2008 |
| Last Updated: | February 24, 2016 |
| Health Authority: | France: Ministry of Health |
| Individual Participant Data | |
| 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 |
ClinicalTrials.gov processed this record on September 23, 2016