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

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:

MedlinePlus related topics: Personality Disorders Suicide

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

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01512602

Locations


Denmark
Mental Health Services, Research Unit, Bispebjerg
Copenhagen NV., Denmark, 2400

Sponsors and Collaborators

Mental Health Services in the Capital Region, Denmark

Lundbeck Foundation

University of Copenhagen

More Information

No publications provided by Mental Health Services in the Capital Region, Denmark

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

Andreasson K, Krogh J, Rosenbaum B, Gluud C, Jobes DA, Nordentoft M. The DiaS trial: dialectical behavior therapy versus collaborative assessment and management of suicidality on self-harm in patients with a recent suicide attempt and borderline personality disorder traits - study protocol for a randomized controlled trial. Trials. 2014 May 29;15:194. doi: 10.1186/1745-6215-15-194.


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:	April 14, 2014
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:


Borderline Personality Disorder Personality Disorders Mental Disorders

ClinicalTrials.gov processed this record on March 03, 2015

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