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

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

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT01512602
Acronym
DiaS
Enrollment
108
Registered
2012-01-19
Start date
2012-01-31
Completion date
2014-07-31
Last updated
2015-04-28

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Borderline Personality Disorder, Suicide

Keywords

Borderline Personality Disorder traits, Suicide prevention, Self-harm, Dialectical Behavior Therapy, DBT, Collaborative Assessment and Management of Suicidology, CAMS

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.

Interventions

BEHAVIORALDBT

16 weeks DBT treatment

BEHAVIORALCAMS

CAMS-informed psychotherapy

Sponsors

Lundbeck Foundation
CollaboratorOTHER
University of Copenhagen
CollaboratorOTHER
Mental Health Services in the Capital Region, Denmark
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Investigator, Outcomes Assessor)

Eligibility

Sex/Gender
ALL
Age
18 Years to 65 Years
Healthy volunteers
No

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

Design outcomes

Primary

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

MeasureTime frameDescription
ImpulsivityAssessed at baseline, after treatment period (16 weeks), Week 28 and 52 after inclusionMeasured by Barratts Impulsivity Scale (BIS-11)
Consumptions of services in hospital care.After treatment period (16 weeks), Week 28 and 52 after inclusionRegister 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 ideationAssessed at baseline, after treatment period (16 weeks), Week 28 and 52 after inclusionMeasured by Beck's Suididal Ideation Scale (SSI-21)
Severity of borderline personality disorder symptoms.Assessed at baseline, after treatment period (16 weeks), Week 28 and 52 after inclusionMeasured by Zanarini Borderline Personality Scale.
Depressive symptomsAssessed at baseline, after treatment period (16 weeks), Week 28 and 52 after inclusionMeasured by HDRS-17 and BDI.
HopelessnessAssessed at baseline, after treatment period (16 weeks), Week 28 and 52 after inclusion.Measured by Becks Hopelessness Scale.
Self EsteemAssessed at baseline, after treatment period (16 weeks), Week 28 and 52 after inclusionMeasured by Rosenbergs Self esteem Scale (RSE).
Suicide related behavior.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
AngerAssessed at baseline, after treatment period (16 weeks), Week 28 and 52 after inclusionMeasured by State Trait Anger Scale.

Countries

Denmark

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Mar 20, 2026