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

The recruitment status of this study is unknown because the information has not been verified recently.
Verified January 2005 by Leiden University Medical Center.
Recruitment status was  Recruiting
Sponsor:
Collaborator:
ZonMw: The Netherlands Organisation for Health Research and Development
Information provided by:
Leiden University Medical Center
ClinicalTrials.gov Identifier:
NCT00169884
First received: September 13, 2005
Last updated: January 31, 2006
Last verified: January 2005
  Purpose

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 Intervention Phase
Self-Injurious Behavior
Behavioral: cognitive-behavioural therapy
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind
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

Resource links provided by NLM:


Further study details as provided by Leiden University Medical Center:

Primary Outcome Measures:
  • repetition of DSH

Secondary Outcome Measures:
  • 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.

Estimated Enrollment: 120
Study Start Date: March 2002
Estimated Study Completion Date: March 2007
  Show Detailed Description

  Eligibility

Ages Eligible for Study:   15 Years to 35 Years
Genders Eligible for Study:   Both
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.

  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: 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
  More Information

Additional Information:
No publications provided

ClinicalTrials.gov Identifier: NCT00169884     History of Changes
Other Study ID Numbers: 2100.0068
Study First Received: September 13, 2005
Last Updated: January 31, 2006
Health Authority: Netherlands: The Central Committee on Research Involving Human Subjects (CCMO)

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

Additional relevant MeSH terms:
Self-Injurious Behavior
Behavioral Symptoms

ClinicalTrials.gov processed this record on April 16, 2014