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

Primary Purpose

Borderline Personality Disorder, Suicide

Status
Completed
Phase
Not Applicable
Locations
Denmark
Study Type
Interventional
Intervention
DBT
CAMS
Sponsored by
Mental Health Services in the Capital Region, Denmark
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Borderline Personality Disorder focused on measuring Borderline Personality Disorder traits, Suicide prevention, Self-harm, Dialectical Behavior Therapy, DBT, Collaborative Assessment and Management of Suicidology, CAMS

Eligibility Criteria

18 Years - 65 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Mental Health Services, Research Unit, Bispebjerg

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Active Comparator

Arm Label

Dialectical Behavior Therapy DBT

CAMS

Arm Description

16 weeks DBT-treatment

Collaborative Assessment and Management of Suicidality, CAMS-informed supportive psychotherapy

Outcomes

Primary Outcome Measures

Number of repeated self-harming acts including suicide attempts (change in number of self-harming acts).
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
Measured by HDRS-17 and BDI.
Impulsivity
Measured by Barratts Impulsivity Scale (BIS-11)
Consumptions of services in hospital care.
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
Measured by Beck's Suididal Ideation Scale (SSI-21)
Severity of borderline personality disorder symptoms.
Measured by Zanarini Borderline Personality Scale.
Anger
Measured by State Trait Anger Scale.
Hopelessness
Measured by Becks Hopelessness Scale.
Self Esteem
Measured by Rosenbergs Self esteem Scale (RSE).
Suicide related behavior.
Measured by Suicide Attempt Self Injury Interview (SASII) and Beck's suicide intent Scale

Full Information

First Posted
December 21, 2011
Last Updated
April 25, 2015
Sponsor
Mental Health Services in the Capital Region, Denmark
Collaborators
Lundbeck Foundation, University of Copenhagen
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1. Study Identification

Unique Protocol Identification Number
NCT01512602
Brief Title
Efficacy of Dialectical Behavior Therapy Versus CAMS-informed Supportive Psychotherapy on Self Harming Behavior
Acronym
DiaS
Official Title
Efficacy of Dialectical Behavior Therapy in Patient With Self Harming Behavior and Traits Within the Spectrum of Borderline Personality Disorder.
Study Type
Interventional

2. Study Status

Record Verification Date
April 2015
Overall Recruitment Status
Completed
Study Start Date
January 2012 (undefined)
Primary Completion Date
July 2014 (Actual)
Study Completion Date
July 2014 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Mental Health Services in the Capital Region, Denmark
Collaborators
Lundbeck Foundation, University of Copenhagen

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Borderline Personality Disorder, Suicide
Keywords
Borderline Personality Disorder traits, Suicide prevention, Self-harm, Dialectical Behavior Therapy, DBT, Collaborative Assessment and Management of Suicidology, CAMS

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
InvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
108 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Dialectical Behavior Therapy DBT
Arm Type
Active Comparator
Arm Description
16 weeks DBT-treatment
Arm Title
CAMS
Arm Type
Active Comparator
Arm Description
Collaborative Assessment and Management of Suicidality, CAMS-informed supportive psychotherapy
Intervention Type
Behavioral
Intervention Name(s)
DBT
Intervention Description
16 weeks DBT treatment
Intervention Type
Behavioral
Intervention Name(s)
CAMS
Intervention Description
CAMS-informed psychotherapy
Primary Outcome Measure Information:
Title
Number of repeated self-harming acts including suicide attempts (change in number of self-harming acts).
Description
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).
Time Frame
Week 0 (baseline), 17, 28, 52.
Secondary Outcome Measure Information:
Title
Depressive symptoms
Description
Measured by HDRS-17 and BDI.
Time Frame
Assessed at baseline, after treatment period (16 weeks), Week 28 and 52 after inclusion
Title
Impulsivity
Description
Measured by Barratts Impulsivity Scale (BIS-11)
Time Frame
Assessed at baseline, after treatment period (16 weeks), Week 28 and 52 after inclusion
Title
Consumptions of services in hospital care.
Description
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.
Time Frame
After treatment period (16 weeks), Week 28 and 52 after inclusion
Title
Suicidal ideation
Description
Measured by Beck's Suididal Ideation Scale (SSI-21)
Time Frame
Assessed at baseline, after treatment period (16 weeks), Week 28 and 52 after inclusion
Title
Severity of borderline personality disorder symptoms.
Description
Measured by Zanarini Borderline Personality Scale.
Time Frame
Assessed at baseline, after treatment period (16 weeks), Week 28 and 52 after inclusion
Title
Anger
Description
Measured by State Trait Anger Scale.
Time Frame
Assessed at baseline, after treatment period (16 weeks), Week 28 and 52 after inclusion
Title
Hopelessness
Description
Measured by Becks Hopelessness Scale.
Time Frame
Assessed at baseline, after treatment period (16 weeks), Week 28 and 52 after inclusion.
Title
Self Esteem
Description
Measured by Rosenbergs Self esteem Scale (RSE).
Time Frame
Assessed at baseline, after treatment period (16 weeks), Week 28 and 52 after inclusion
Title
Suicide related behavior.
Description
Measured by Suicide Attempt Self Injury Interview (SASII) and Beck's suicide intent Scale
Time Frame
Assessed at baseline, after treatment period (16 weeks), Week 28 and 52 after inclusion.

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
Eligibility 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
Facility Information:
Facility Name
Mental Health Services, Research Unit, Bispebjerg
City
Copenhagen NV.
ZIP/Postal Code
2400
Country
Denmark

12. IPD Sharing Statement

Citations:
PubMed Identifier
33884617
Citation
Witt KG, Hetrick SE, Rajaram G, Hazell P, Taylor Salisbury TL, Townsend E, Hawton K. Psychosocial interventions for self-harm in adults. Cochrane Database Syst Rev. 2021 Apr 22;4(4):CD013668. doi: 10.1002/14651858.CD013668.pub2.
Results Reference
derived
PubMed Identifier
32368793
Citation
Storebo OJ, Stoffers-Winterling JM, Vollm BA, Kongerslev MT, Mattivi JT, Jorgensen MS, Faltinsen E, Todorovac A, Sales CP, Callesen HE, Lieb K, Simonsen E. Psychological therapies for people with borderline personality disorder. Cochrane Database Syst Rev. 2020 May 4;5(5):CD012955. doi: 10.1002/14651858.CD012955.pub2.
Results Reference
derived
PubMed Identifier
26854478
Citation
Andreasson K, Krogh J, Wenneberg C, Jessen HK, Krakauer K, Gluud C, Thomsen RR, Randers L, Nordentoft M. EFFECTIVENESS OF DIALECTICAL BEHAVIOR THERAPY VERSUS COLLABORATIVE ASSESSMENT AND MANAGEMENT OF SUICIDALITY TREATMENT FOR REDUCTION OF SELF-HARM IN ADULTS WITH BORDERLINE PERSONALITY TRAITS AND DISORDER-A RANDOMIZED OBSERVER-BLINDED CLINICAL TRIAL. Depress Anxiety. 2016 Jun;33(6):520-30. doi: 10.1002/da.22472. Epub 2016 Feb 8.
Results Reference
derived
PubMed Identifier
24885904
Citation
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.
Results Reference
derived

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

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