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NCT Number: NCT01512602

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

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.

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Key information

Conditions

Borderline Personality Disorder Behavior Behavioral Symptoms Mental Disorders Personality Disorders Self-Injurious Behavior Suicide Suicide Prevention

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Mental Health Services, Research Unit, Bispebjerg

Copenhagen NV., 2400, Denmark

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

DBT

Behavioral

16 weeks DBT treatment

CAMS

Behavioral

CAMS-informed psychotherapy

Primary outcomes

  1. 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

  1. Depressive symptoms

    Time frame: Assessed at baseline, after treatment period (16 weeks), Week 28 and 52 after inclusion

    Measured by HDRS-17 and BDI.

  2. Impulsivity

    Time frame: Assessed at baseline, after treatment period (16 weeks), Week 28 and 52 after inclusion

    Measured by Barratts Impulsivity Scale (BIS-11)

  3. 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.

  4. 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)

  5. 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.

  6. Anger

    Time frame: Assessed at baseline, after treatment period (16 weeks), Week 28 and 52 after inclusion

    Measured by State Trait Anger Scale.

  7. Hopelessness

    Time frame: Assessed at baseline, after treatment period (16 weeks), Week 28 and 52 after inclusion.

    Measured by Becks Hopelessness Scale.

  8. 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).

  9. 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

Sponsors and collaborators

Lead sponsor

Mental Health Centre Copenhagen, Bispebjerg and Frederiksberg Hospital

Other

Collaborators

  • Lundbeck Foundation
  • University of Copenhagen

Registry information

Official study title

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

Acronym: DiaS

Important dates

Study start
2012
Primary completion
2014
Study completion
2014
First posted
Jan 19, 2012
Registry last updated
Apr 28, 2015

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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