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Effectiveness of Standard Emergency Department Psychiatric Treatment Associated With Treatment Delivery by a Suicide Prevention Center

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT00641498
Recruitment Status : Completed
First Posted : March 24, 2008
Last Update Posted : March 30, 2015
Sponsor:
Information provided by (Responsible Party):
University Hospital, Toulouse

Tracking Information
First Submitted Date  ICMJE March 17, 2008
First Posted Date  ICMJE March 24, 2008
Last Update Posted Date March 30, 2015
Study Start Date  ICMJE March 2007
Actual Primary Completion Date December 2009   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: March 17, 2008)
Suicide behavior defined by self poisoning or other suicidal attempts in the emergency departments of the region. Death by suicide will be identified by the examination of information obtained from the national death statistics office (INSERM). [ Time Frame: 2 years ]
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: March 17, 2008)
Level of depression, suicide ideation, level of despair, level of alexithymia [ Time Frame: 2 years ]
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Effectiveness of Standard Emergency Department Psychiatric Treatment Associated With Treatment Delivery by a Suicide Prevention Center
Official Title  ICMJE Effectiveness of Standard Emergency Department Psychiatric Treatment Compared With Effectiveness of Standard Emergency Department Psychiatric Treatment Associated With Treatment Delivery by a Suicide Prevention Center.
Brief Summary

Very few studies have proved the effectiveness of treatment for suicide attempt patients. Our objective is to evaluate the addition of the resources of an suicide prevention centre to standard psychiatric treatment in the Emergency Department. Consecutive suicide attempt patients in 2 Emergency departments (multicenter study) were included after standard psychiatric treatment and referral. After Written informed consent, psychological assessment (depression, suicide intention) was carried out After randomisation, control patients were given an information card describing the Suicide Prevention Center (SPC); experimental patients had a first meeting with a psychologist of the SPC.

To verify the hypothesis of a decrease in suicidal behaviors in the experimental group, an evaluation of these behaviors was carried out every month during a two year follow-up.

Detailed Description Very few studies have proved the effectiveness of treatment for suicide attempt patients. Our objective is to evaluate the addition of the resources of an existent suicide prevention centre to standard psychiatric treatment in the Emergency Department. Consecutive suicide attempt (self poisoning) patients in 2 Emergency departments (multicenter study) were included after standard psychiatric treatment and referral. After Written informed consent, psychological assessment (depression, suicide intent scale/SIS Beck Depression Inventory, Toronto Ale, Beck Hopelessness Sc, Audit, mini, PDQ 4) was carried out After randomisation, control patients were given an information card describing the Suicide Prevention Center (SPC); experimental patients had a first meeting with a psychologist of the SPC. The number of subjects included should be 405 per group. To verify the hypothesis of a decrease in suicidal behaviors in the experimental group, an evaluation of these behaviors was carried out every month during a two year follow-up The frequency of subsequent suicidal behavior will be monitored by the scrutiny of the Emergency Dept records. Death by suicide will be identified by the examination of information obtained from the national death statistics office (INSERM).
Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Supportive Care
Condition  ICMJE Suicide Attempted
Intervention  ICMJE Behavioral: Psychotherapy
Individual supportive
Study Arms  ICMJE
  • No Intervention: Control
    Usual therapy
  • Experimental: Active group
    Individual supportive psychotherapy initiated in the Emergency department
    Intervention: Behavioral: Psychotherapy
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: March 27, 2015)
607
Original Estimated Enrollment  ICMJE
 (submitted: March 17, 2008)
810
Actual Study Completion Date  ICMJE October 2011
Actual Primary Completion Date December 2009   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • parasuicide by self-poisoning
  • Glasgow score=15
  • Standard psychiatric treatment

Exclusion Criteria:

  • No speaking french
  • committed inpatient
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE France
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT00641498
Other Study ID Numbers  ICMJE 0601401
PHRC suicide
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party University Hospital, Toulouse
Study Sponsor  ICMJE University Hospital, Toulouse
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Philippe BIRMES, PhD University Hospital, Toulouse
PRS Account University Hospital, Toulouse
Verification Date March 2015

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP