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

Primary Purpose

Borderline Personality Disorder

Status
Completed
Phase
Not Applicable
Locations
France
Study Type
Interventional
Intervention
24 hour phone line
treatment as usual
Sponsored by
Assistance Publique - Hôpitaux de Paris
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional health services research trial for Borderline Personality Disorder focused on measuring borderline personality disorder, suicide, suicidality, suicide attempt, suicidal behavior, self-injurious behavior, self-harm behavior, suicide prevention center, telephone intervention

Eligibility Criteria

18 Years - 40 Years (Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Hôpital St Anne
  • Hopital Cochin Centre de recherche Clinique Paris Centre

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

1

2

Arm Description

Patient benefits from treatment as usual plus access to a crisis 24 hour phone line.

Patient benefits from treatment as usual

Outcomes

Primary Outcome Measures

Rate of suicide attempts

Secondary Outcome Measures

rate of self injurious behaviors

Full Information

First Posted
January 16, 2008
Last Updated
February 24, 2016
Sponsor
Assistance Publique - Hôpitaux de Paris
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1. Study Identification

Unique Protocol Identification Number
NCT00603421
Brief Title
Effectiveness of a 24 Hour Phone Line on the Rate of Suicide Attempts in Borderline Patients
Official Title
Effectiveness of a 24 Hour Phone Line on the Rate of Suicide Attempts in Borderline Patients
Study Type
Interventional

2. Study Status

Record Verification Date
February 2016
Overall Recruitment Status
Completed
Study Start Date
February 2009 (undefined)
Primary Completion Date
October 2014 (Actual)
Study Completion Date
December 2014 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Assistance Publique - Hôpitaux de Paris

4. Oversight

Data Monitoring Committee
Yes

5. 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.
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).

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Borderline Personality Disorder
Keywords
borderline personality disorder, suicide, suicidality, suicide attempt, suicidal behavior, self-injurious behavior, self-harm behavior, suicide prevention center, telephone intervention

7. Study Design

Primary Purpose
Health Services Research
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Investigator
Allocation
Randomized
Enrollment
318 (Actual)

8. Arms, Groups, and Interventions

Arm Title
1
Arm Type
Experimental
Arm Description
Patient benefits from treatment as usual plus access to a crisis 24 hour phone line.
Arm Title
2
Arm Type
Active Comparator
Arm Description
Patient benefits from treatment as usual
Intervention Type
Other
Intervention Name(s)
24 hour phone line
Intervention Description
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
Intervention Type
Other
Intervention Name(s)
treatment as usual
Intervention Description
Treatment as usual
Primary Outcome Measure Information:
Title
Rate of suicide attempts
Time Frame
Annual
Secondary Outcome Measure Information:
Title
rate of self injurious behaviors
Time Frame
annual

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
40 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Alexandra Pham-Scottez, MD
Organizational Affiliation
Centre Hospitalier Sainte Anne
Official's Role
Principal Investigator
Facility Information:
Facility Name
Hôpital St Anne
City
Paris
ZIP/Postal Code
75014
Country
France
Facility Name
Hopital Cochin Centre de recherche Clinique Paris Centre
City
Paris
ZIP/Postal Code
75679
Country
France

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
PubMed Identifier
33884617
Citation
Witt KG, Hetrick SE, Rajaram G, Hazell P, Taylor Salisbury TL, Townsend E, Hawton K. Psychosocial interventions for self-harm in adults. Cochrane Database Syst Rev. 2021 Apr 22;4(4):CD013668. doi: 10.1002/14651858.CD013668.pub2.
Results Reference
derived
PubMed Identifier
32368793
Citation
Storebo OJ, Stoffers-Winterling JM, Vollm BA, Kongerslev MT, Mattivi JT, Jorgensen MS, Faltinsen E, Todorovac A, Sales CP, Callesen HE, Lieb K, Simonsen E. Psychological therapies for people with borderline personality disorder. Cochrane Database Syst Rev. 2020 May 4;5(5):CD012955. doi: 10.1002/14651858.CD012955.pub2.
Results Reference
derived

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

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