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

• ClinicalTrials.gov Identifier: NCT01512602
• Recruitment Status: Completed
• First Posted: January 19, 2012
• Last Update Posted: April 28, 2015
• Sponsor: Mental Health Services in the Capital Region, Denmark
• Collaborators: Lundbeck Foundation; University of Copenhagen
• Information provided by (Responsible Party): Merete Nordentoft, Mental Health Services in the Capital Region, Denmark

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.

Condition or disease	Intervention/treatment	Phase
Borderline Personality Disorder; Suicide	Behavioral: DBT; Behavioral: CAMS	Not Applicable

Study Design

• Study Type: Interventional (Clinical Trial)
• Actual Enrollment: 108 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: Double (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.
• Study Start Date: January 2012
• Actual Primary Completion Date: July 2014
• Actual Study Completion Date: July 2014

Arms and Interventions

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

Outcome Measures

Primary Outcome Measures :

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 Outcome Measures :

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

Eligibility Criteria

• Ages Eligible for Study: 18 Years to 65 Years (Adult, Older Adult)
• Sexes Eligible for Study: All
• 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

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

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

Storebø OJ, Stoffers-Winterling JM, Völlm BA, Kongerslev MT, Mattivi JT, Jørgensen 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:CD012955. doi: 10.1002/14651858.CD012955.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.

• Responsible Party: Merete Nordentoft, Professor, MD, Mental Health Services in the Capital Region, Denmark
• ClinicalTrials.gov Identifier: NCT01512602
• Other Study ID Numbers: RHP-DiaS-002
• First Posted: January 19, 2012
• Last Update Posted: April 28, 2015
• Last Verified: April 2015

Keywords provided by Merete Nordentoft, 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:

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