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Efficacy of Dialectical Behavior Therapy Versus CAMS-informed Supportive Psychotherapy on Self Harming Behavior (DiaS)

This study is currently recruiting participants.
Verified January 2012 by Mental Health Services in the Capital Region, Denmark
Sponsor:
Collaborators:
Lundbeck Foundation
University of Copenhagen
Information provided by (Responsible Party):
Merete Nordentoft, Mental Health Services in the Capital Region, Denmark
ClinicalTrials.gov Identifier:
NCT01512602
First received: December 21, 2011
Last updated: January 23, 2012
Last verified: January 2012
History of Changes
  Purpose

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.


Condition Intervention
Borderline Personality Disorder
Suicide
 Behavioral: DBT
Behavioral: CAMS

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Efficacy of Dialectical Behavior Therapy in Patient With Self Harming Behavior and Traits Within the Spectrum of Borderline Personality Disorder.

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Mental Health Services in the Capital Region, Denmark:

Primary Outcome Measures:
  • Number of repeated self-harming acts including suicide attempts (change in number of self-harming acts). [ Time Frame: Week 0 (baseline), 17, 28, 52. ] [ Designated as safety issue: No ]
    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 Outcome Measures:
  • Depressive symptoms [ Time Frame: Assessed at baseline, after treatment period (16 weeks), Week 28 and 52 after inclusion ] [ Designated as safety issue: No ]
    Measured by HDRS-17 and BDI.

  • Impulsivity [ Time Frame: Assessed at baseline, after treatment period (16 weeks), Week 28 and 52 after inclusion ] [ Designated as safety issue: No ]
    Measured by Barratts Impulsivity Scale (BIS-11)

  • Consumptions of services in hospital care. [ Time Frame: After treatment period (16 weeks), Week 28 and 52 after inclusion ] [ Designated as safety issue: No ]
    Register based information: Contact with hospital contact with code 4 (self-harm act), or suicide attemp X60-X84, or poisioning by weak analgesia (T39), hypnotics (T52), or psychothopic drugs (T43). Vital status, causes of death, use of bed days and outpatients services.

  • Suicidal ideation [ Time Frame: Assessed at baseline, after treatment period (16 weeks), Week 28 and 52 after inclusion ] [ Designated as safety issue: No ]
    Measured by Beck's Suididal Ideation Scale (SSI-21)

  • Severity of borderline personality disorder symptoms. [ Time Frame: Assessed at baseline, after treatment period (16 weeks), Week 28 and 52 after inclusion ] [ Designated as safety issue: No ]
    Measured by Zanarini Borderline Personality Scale.

  • Anger [ Time Frame: Assessed at baseline, after treatment period (16 weeks), Week 28 and 52 after inclusion ] [ Designated as safety issue: No ]
    Measured by State Trait Anger Scale.

  • Hopelessness [ Time Frame: Assessed at baseline, after treatment period (16 weeks), Week 28 and 52 after inclusion. ] [ Designated as safety issue: No ]
    Measured by Becks Hopelessness Scale.

  • Self Esteem [ Time Frame: Assessed at baseline, after treatment period (16 weeks), Week 28 and 52 after inclusion ] [ Designated as safety issue: No ]
    Measured by Rosenbergs Self esteem Scale (RSE).

  • Suicide related behavior. [ Time Frame: Assessed at baseline, after treatment period (16 weeks), Week 28 and 52 after inclusion. ] [ Designated as safety issue: No ]
    Measured by Suicide Attempt Self Injury Interview (SASII) and Beck's suicide intent Scale


Estimated Enrollment: 160
Study Start Date: January 2012
Estimated Study Completion Date: July 2014
Estimated Primary Completion Date: July 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: Dialectical Behavior Therapy DBT
16 weeks DBT-treatment
 Behavioral: DBT
16 weeks DBT treatment
Active Comparator: CAMS
Collaborative Assessment and Management of Suicidality, CAMS-informed supportive psychotherapy
 Behavioral: CAMS
CAMS-informed psychotherapy

  Eligibility

Ages Eligible for Study:   18 Years to 65 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01512602

Contacts
Contact: Merete Nordentoft, Professor + 45 20607552 mn@dadlnet.dk
Contact: Kate Andreasson Aamund, MD + 45 60407838 kate.trein.andreasson@regionh.dk

Locations
Denmark
Mental Health Services, Research Unit, Bispebjerg Recruiting
Copenhagen NV., Denmark, 2400
Contact: Kate Andreasson Aamund, MD     +45 60407838     kate.trein.andreasson@regionh.dk    
Sub-Investigator: Kate Andreasson Aamund, MD            
Principal Investigator: Merete Nordentoft, Professor, MD            
Sponsors and Collaborators
Mental Health Services in the Capital Region, Denmark
Lundbeck Foundation
University of Copenhagen
  More Information

No publications provided

Responsible Party: Merete Nordentoft, Professor, MD, Mental Health Services in the Capital Region, Denmark
ClinicalTrials.gov Identifier: NCT01512602     History of Changes
Other Study ID Numbers: RHP-DiaS-002
Study First Received: December 21, 2011
Last Updated: January 23, 2012
Health Authority: Danish Data Protection Agengy Denmark':' Approval Number 2007-568-0015.
Ethics Committee Denmark Denmark':'

Keywords provided by Mental Health Services in the Capital Region, Denmark:
Borderline Personality Disorder traits
Suicide prevention
Self-harm
Dialectical Behavior Therapy
 DBT
Collaborative Assessment and Management of Suicidology
CAMS

Additional relevant MeSH terms:
Personality Disorders
Borderline Personality Disorder
Suicide
 Mental Disorders
Self-Injurious Behavior
Behavioral Symptoms

ClinicalTrials.gov processed this record on May 16, 2013