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The Efficacy of a Cognitive-Behavioural Intervention in Deliberate Self-Harm Patients

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ClinicalTrials.gov Identifier: NCT00169884
Recruitment Status : Unknown
Verified January 2005 by Leiden University Medical Center.
Recruitment status was:  Recruiting
First Posted : September 15, 2005
Last Update Posted : February 1, 2006
Sponsor:
Collaborator:
ZonMw: The Netherlands Organisation for Health Research and Development
Information provided by:
Leiden University Medical Center

Brief Summary:
The purpose of this study is to evaluate whether the proposed cognitive-behavioural intervention is effective for DSH patients in the age group 15-35 years. In addition, we will examine which elements derived from the theoretical model can explain the efficacy of the intervention.

Condition or disease Intervention/treatment Phase
Self-Injurious Behavior Behavioral: cognitive-behavioural therapy Phase 2

  Show Detailed Description

Study Type : Interventional  (Clinical Trial)
Enrollment : 120 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single
Primary Purpose: Treatment
Official Title: The Efficacy of a Cognitive-Behavioural Intervention in Deliberate Self-Harm Patients: A Randomized Controlled Trial Among Adolescents and Young Adults
Study Start Date : March 2002
Study Completion Date : March 2007

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Self-harm
U.S. FDA Resources




Primary Outcome Measures :
  1. repetition of DSH

Secondary Outcome Measures :
  1. psychiatric diagnosis, depression, hopelessness, suicidal intent, suicidal cognitions, self-concept, (cognitive) coping, emotion regulation difficulties, impulsivity, social support, hostility, personality disorder related beliefs and attachment style.


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Ages Eligible for Study:   15 Years to 35 Years   (Child, Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

DSH patients will be included if they recently have been engaged in an act of DSH including overdoses of medication, ingestion of chemical substances and self-inflicted injuries according to the definition which is used in the WHO/Euro Multicentre Study on parasuicide: "An act with non-fatal outcome in which an individual deliberately initiates a non-habitual behaviour, that without intervention from others will cause self-harm, or deliberately ingests a substance in excess of the prescribed or generally recognised dosage, and which is aimed at realising changes that the person desires via the actual or expected physical consequences" (Platt et al., 1992). In addition, only DSH patients aged 15-35 will be included.

Exclusion Criteria:

DSH patients with severe psychiatric disorders requiring intensive long-term psychiatric treatment, such as schizophrenia, will be excluded.


Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00169884


Contacts
Contact: Nadja Slee nadja.slee@fsw.leidenuniv.nl

Locations
Netherlands
Leiden University Medical Center Recruiting
Leiden, Netherlands
Contact: Nadja Slee         
Principal Investigator: Nadja Slee         
MCH Westeinde Recruiting
The Hague, Netherlands
Contact: Martijn Kamphuis         
Sub-Investigator: Martijn Kamphuis         
Sponsors and Collaborators
Leiden University Medical Center
ZonMw: The Netherlands Organisation for Health Research and Development
Investigators
Study Chair: Philip Spinhoven, prof. dr. Leiden University, department of clinical psychology
Study Director: Nadia Garnefski, dr. Leiden University department of clinical psychology
Principal Investigator: Nadja Slee, MSc Leiden University department of clinical psychology
Study Director: Ella Arensman, dr. National Suicide Research Foundation, Cork

Additional Information:
ClinicalTrials.gov Identifier: NCT00169884     History of Changes
Other Study ID Numbers: 2100.0068
First Posted: September 15, 2005    Key Record Dates
Last Update Posted: February 1, 2006
Last Verified: January 2005

Keywords provided by Leiden University Medical Center:
Deliberate Self-Harm,
cognitive-behavioural therapy,
integrative approach

Additional relevant MeSH terms:
Self-Injurious Behavior
Self Mutilation
Behavioral Symptoms
Wounds and Injuries