NCT00603421

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
318

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Feb 2009

Longer than P75 for not_applicable

Geographic Reach
1 country

2 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

January 16, 2008

Completed
13 days until next milestone

First Posted

Study publicly available on registry

January 29, 2008

Completed
1 year until next milestone

Study Start

First participant enrolled

February 1, 2009

Completed
5.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 1, 2014

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2014

Completed
Last Updated

February 25, 2016

Status Verified

February 1, 2016

Enrollment Period

5.7 years

First QC Date

January 16, 2008

Last Update Submit

February 24, 2016

Conditions

Keywords

borderline personality disordersuicidesuicidalitysuicide attemptsuicidal behaviorself-injurious behaviorself-harm behaviorsuicide prevention centertelephone intervention

Outcome Measures

Primary Outcomes (1)

  • Rate of suicide attempts

    Annual

Secondary Outcomes (1)

  • rate of self injurious behaviors

    annual

Study Arms (2)

1

EXPERIMENTAL

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

Other: 24 hour phone line

2

ACTIVE COMPARATOR

Patient benefits from treatment as usual

Other: treatment as usual

Interventions

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

1

Treatment as usual

2

Eligibility Criteria

Age18 Years - 40 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • 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

You may not qualify if:

  • inferior to 18 or superior to 40 years old
  • schizophrenia
  • severe somatic disorder
  • participation refusal
  • participation to another interventional study

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Hôpital St Anne

Paris, 75014, France

Location

Hopital Cochin Centre de recherche Clinique Paris Centre

Paris, 75679, France

Location

Related Publications (2)

  • 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.

  • 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.

MeSH Terms

Conditions

Borderline Personality DisorderSuicideSuicidal IdeationSuicide, AttemptedSelf-Injurious Behavior

Interventions

Therapeutics

Condition Hierarchy (Ancestors)

Personality DisordersMental DisordersBehavioral SymptomsBehavior

Study Officials

  • Alexandra Pham-Scottez, MD

    Centre Hospitalier Sainte Anne

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
INVESTIGATOR
Purpose
HEALTH SERVICES RESEARCH
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

January 16, 2008

First Posted

January 29, 2008

Study Start

February 1, 2009

Primary Completion

October 1, 2014

Study Completion

December 1, 2014

Last Updated

February 25, 2016

Record last verified: 2016-02

Data Sharing

IPD Sharing
Will not share

Locations