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

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

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.

Study Overview

• Status: Completed
• Conditions: Suicide; Borderline Personality Disorder
• Intervention / Treatment: Behavioral: DBT; Behavioral: CAMS

• Study Type: Interventional
• Enrollment (Actual): 108
• Phase: Not Applicable

Contacts and Locations

Study Locations

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

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 65 years (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: TREATMENT
• Allocation: RANDOMIZED
• Interventional Model: PARALLEL
• Masking: DOUBLE

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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).	Week 0 (baseline), 17, 28, 52.

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Depressive symptoms	Measured by HDRS-17 and BDI.	Assessed at baseline, after treatment period (16 weeks), Week 28 and 52 after inclusion
Impulsivity	Measured by Barratts Impulsivity Scale (BIS-11)	Assessed at baseline, after treatment period (16 weeks), Week 28 and 52 after inclusion
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.	After treatment period (16 weeks), Week 28 and 52 after inclusion
Suicidal ideation	Measured by Beck's Suididal Ideation Scale (SSI-21)	Assessed at baseline, after treatment period (16 weeks), Week 28 and 52 after inclusion
Severity of borderline personality disorder symptoms.	Measured by Zanarini Borderline Personality Scale.	Assessed at baseline, after treatment period (16 weeks), Week 28 and 52 after inclusion
Anger	Measured by State Trait Anger Scale.	Assessed at baseline, after treatment period (16 weeks), Week 28 and 52 after inclusion
Hopelessness	Measured by Becks Hopelessness Scale.	Assessed at baseline, after treatment period (16 weeks), Week 28 and 52 after inclusion.
Self Esteem	Measured by Rosenbergs Self esteem Scale (RSE).	Assessed at baseline, after treatment period (16 weeks), Week 28 and 52 after inclusion
Suicide related behavior.	Measured by Suicide Attempt Self Injury Interview (SASII) and Beck's suicide intent Scale	Assessed at baseline, after treatment period (16 weeks), Week 28 and 52 after inclusion.

Collaborators and Investigators

• Sponsor: Mental Health Services in the Capital Region, Denmark
• Collaborators: University of Copenhagen; Lundbeck Foundation

Publications and helpful links

General Publications

• 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.
• 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.
• 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.
• 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.

Study record dates

Study Major Dates

• Study Start: January 1, 2012
• Primary Completion (ACTUAL): July 1, 2014
• Study Completion (ACTUAL): July 1, 2014

Study Registration Dates

• First Submitted: December 21, 2011
• First Submitted That Met QC Criteria: January 14, 2012
• First Posted (ESTIMATE): January 19, 2012

Study Record Updates

• Last Update Posted (ESTIMATE): April 28, 2015
• Last Update Submitted That Met QC Criteria: April 25, 2015
• Last Verified: April 1, 2015

More Information

Terms related to this study

• Keywords: Suicide prevention; Dialectical Behavior Therapy; DBT; Self-harm; CAMS; Borderline Personality Disorder traits; Collaborative Assessment and Management of Suicidology
• Additional Relevant MeSH Terms: Behavioral Symptoms; Mental Disorders; Self-Injurious Behavior; Personality Disorders; Suicide; Borderline Personality Disorder
• Other Study ID Numbers: RHP-DiaS-002