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

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: NCT01512602
Recruitment Status : Completed
First Posted : January 19, 2012
Last Update Posted : April 28, 2015
Sponsor:
Collaborators:
Lundbeck Foundation
University of Copenhagen
Information provided by (Responsible Party):
Merete Nordentoft, Mental Health Services in the Capital Region, Denmark

Tracking Information
First Submitted Date  ICMJE December 21, 2011
First Posted Date  ICMJE January 19, 2012
Last Update Posted Date April 28, 2015
Study Start Date  ICMJE January 2012
Actual Primary Completion Date July 2014   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: January 14, 2012)
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).
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: January 23, 2012)
  • Depressive symptoms [ Time Frame: Assessed at baseline, after treatment period (16 weeks), Week 28 and 52 after inclusion ]
    Measured by HDRS-17 and BDI.
  • Impulsivity [ Time Frame: Assessed at baseline, after treatment period (16 weeks), Week 28 and 52 after inclusion ]
    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 ]
    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 ]
    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 ]
    Measured by Zanarini Borderline Personality Scale.
  • Anger [ Time Frame: Assessed at baseline, after treatment period (16 weeks), Week 28 and 52 after inclusion ]
    Measured by State Trait Anger Scale.
  • Hopelessness [ Time Frame: Assessed at baseline, after treatment period (16 weeks), Week 28 and 52 after inclusion. ]
    Measured by Becks Hopelessness Scale.
  • Self Esteem [ Time Frame: Assessed at baseline, after treatment period (16 weeks), Week 28 and 52 after inclusion ]
    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. ]
    Measured by Suicide Attempt Self Injury Interview (SASII) and Beck's suicide intent Scale
Original Secondary Outcome Measures  ICMJE
 (submitted: January 14, 2012)
  • Depressive symptoms [ Time Frame: Assessed at baseline, after treatment period (16 weeks), Week 28 and 52 after inclusion ]
    Measured by HDRS-17 and BDI.
  • Impulsity [ Time Frame: Assessed at baseline, after treatment period (16 weeks), Week 28 and 52 after inclusion ]
    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 ]
    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 ]
    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 ]
    Measured by Zanarini Borderline Personality Scale.
  • Anger [ Time Frame: Assessed at baseline, after treatment period (16 weeks), Week 28 and 52 after inclusion ]
    Measured by State Trait Anger Scale.
  • Hopelessness [ Time Frame: Assessed at baseline, after treatment period (16 weeks), Week 28 and 52 after inclusion. ]
    Measured by Becks Hopelessness Scale.
  • Self Esteem [ Time Frame: Assessed at baseline, after treatment period (16 weeks), Week 28 and 52 after inclusion ]
    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. ]
    Measured by Suicide Attempt Self Injury Interview (SASII) and Beck's suicide intent Scale
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Efficacy of Dialectical Behavior Therapy Versus CAMS-informed Supportive Psychotherapy on Self Harming Behavior
Official Title  ICMJE Efficacy of Dialectical Behavior Therapy in Patient With Self Harming Behavior and Traits Within the Spectrum of Borderline Personality Disorder.
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.

Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Condition  ICMJE
  • Borderline Personality Disorder
  • Suicide
Intervention  ICMJE
  • Behavioral: DBT
    16 weeks DBT treatment
  • Behavioral: CAMS
    CAMS-informed psychotherapy
Study Arms  ICMJE
  • Active Comparator: Dialectical Behavior Therapy DBT
    16 weeks DBT-treatment
    Intervention: Behavioral: DBT
  • Active Comparator: CAMS
    Collaborative Assessment and Management of Suicidality, CAMS-informed supportive psychotherapy
    Intervention: Behavioral: CAMS
Publications *

*   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: April 25, 2015)
108
Original Estimated Enrollment  ICMJE
 (submitted: January 14, 2012)
160
Actual Study Completion Date  ICMJE July 2014
Actual Primary Completion Date July 2014   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 65 Years   (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 Denmark
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT01512602
Other Study ID Numbers  ICMJE RHP-DiaS-002
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Merete Nordentoft, Mental Health Services in the Capital Region, Denmark
Study Sponsor  ICMJE Mental Health Services in the Capital Region, Denmark
Collaborators  ICMJE
  • Lundbeck Foundation
  • University of Copenhagen
Investigators  ICMJE Not Provided
PRS Account Mental Health Services in the Capital Region, Denmark
Verification Date April 2015

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