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Clinical Trials/NCT01512602
NCT01512602
Completed
Not Applicable

Efficacy of Dialectical Behavior Therapy in Patient With Self Harming Behavior and Traits Within the Spectrum of Borderline Personality Disorder.

Mental Health Services in the Capital Region, Denmark1 site in 1 country108 target enrollmentJanuary 2012

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Borderline Personality Disorder
Sponsor
Mental Health Services in the Capital Region, Denmark
Enrollment
108
Locations
1
Primary Endpoint
Number of repeated self-harming acts including suicide attempts (change in number of self-harming acts).
Status
Completed
Last Updated
11 years ago

Overview

Brief Summary

Purpose: The purpose of this study is to investigate the efficacy of Dialectical Behavior Therapy (DBT) versus CAMS (Collaborative Assessment and Management of Suicidality) -informed supportive psychotherapy on the risk of self-harm acts and suicide attempts in patients with self behavior and personality traits within the spectrum of borderline personality disorder.

Hypothesis: The hypothesis is 16 weeks of treatment with Dialectical Behavior Therapy (DBT) after a defined manual has a higher efficacy than CAMS-informed supportive psychotherapy on self-harm acts, suicide attempts, suicidal ideation, depressive symptoms, impulsiveness and consumption of hospital services in patients with symptoms within the spectrum of borderline personality disorder (BDP).

Method: The investigators will include 160 patients in the randomized trial to investigate whether 16 weeks of DBT-treatment as a higher efficacy than CAMS-informed supportive psychotherapy on the risk of self-harm acts and suicide attempts in patients with self-harm behavior and personality traits within the spectrum of borderline personality disorder. The trial will meet strict criteria for high quality randomized trials, and will hopefully help to establish evidence for the treatment of this patient group at higher risk of later suicide. There will be performed follow up interviews after 16 weeks, 28 weeks and 52 weeks.

Registry
clinicaltrials.gov
Start Date
January 2012
End Date
July 2014
Last Updated
11 years ago
Study Type
Interventional
Study Design
Parallel
Sex
All

Investigators

Sponsor
Mental Health Services in the Capital Region, Denmark
Responsible Party
Principal Investigator
Principal Investigator

Merete Nordentoft

Professor, MD

Mental Health Services in the Capital Region, Denmark

Eligibility Criteria

Inclusion Criteria

  • 18-65 years of age.
  • Newly suicide attempt within one month of the inclusion date.
  • A minimum of two characteristics in the DSM-IV Borderline Personality Disorder (BPD)
  • Informed consent.

Exclusion Criteria

  • Severe depression.
  • Bipolar disorder.
  • Psychosis within the schizophrenic spectrum.
  • Anorexia Nervosa.
  • Substance abuse.
  • Mental retardation.
  • Dementia.
  • Lack of informed consent

Outcomes

Primary Outcomes

Number of repeated self-harming acts including suicide attempts (change in number of self-harming acts).

Time Frame: Week 0 (baseline), 17, 28, 52.

This information will be obtained as self-reported and through journal entries.How many acts how has taken place between the different time points in the trial (week 0, 17,28, and 52) to actually quantify the self-harming acts in order to find out if the treatment in the two arms can decrease the numbers of self-harming acts, also long term effect (week 52).

Secondary Outcomes

  • Suicide related behavior.(Assessed at baseline, after treatment period (16 weeks), Week 28 and 52 after inclusion.)
  • Depressive symptoms(Assessed at baseline, after treatment period (16 weeks), Week 28 and 52 after inclusion)
  • Suicidal ideation(Assessed at baseline, after treatment period (16 weeks), Week 28 and 52 after inclusion)
  • Anger(Assessed at baseline, after treatment period (16 weeks), Week 28 and 52 after inclusion)
  • Consumptions of services in hospital care.(After treatment period (16 weeks), Week 28 and 52 after inclusion)
  • Severity of borderline personality disorder symptoms.(Assessed at baseline, after treatment period (16 weeks), Week 28 and 52 after inclusion)
  • Hopelessness(Assessed at baseline, after treatment period (16 weeks), Week 28 and 52 after inclusion.)
  • Impulsivity(Assessed at baseline, after treatment period (16 weeks), Week 28 and 52 after inclusion)
  • Self Esteem(Assessed at baseline, after treatment period (16 weeks), Week 28 and 52 after inclusion)

Study Sites (1)

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