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

Suicide Clinical Trial

— DiaS  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01512602
• Other study ID #: RHP-DiaS-002
• Status: Completed
• Phase: N/A
• First received: December 21, 2011
• Last updated: April 25, 2015
• Start date: January 2012
• Est. completion date: July 2014

Study information

• Verified date: April 2015
• Source: Mental Health Services in the Capital Region, Denmark
• Contact: n/a
• Is FDA regulated: No
• Health authority: Danish Data Protection Agengy Denmark':' Approval Number 2007-568-0015.Ethics Committee Denmark Denmark':'
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 108
• Est. completion date: July 2014
• Est. primary completion date: July 2014
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 65 Years

Eligibility

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 Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Investigator, Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Borderline Personality Disorder
• Personality Disorders
• Suicide

Intervention

Behavioral:
• DBT
16 weeks DBT treatment
• CAMS
CAMS-informed psychotherapy

Locations

Country	Name	City	State
Denmark	Mental Health Services, Research Unit, Bispebjerg	Copenhagen NV.

Sponsors (3)

Lead Sponsor	Collaborator
Mental Health Services in the Capital Region, Denmark	Lundbeck Foundation, University of Copenhagen

Country where clinical trial is conducted

Denmark, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	No
Secondary	Depressive symptoms	Measured by HDRS-17 and BDI.	Assessed at baseline, after treatment period (16 weeks), Week 28 and 52 after inclusion	No
Secondary	Impulsivity	Measured by Barratts Impulsivity Scale (BIS-11)	Assessed at baseline, after treatment period (16 weeks), Week 28 and 52 after inclusion	No
Secondary	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	No
Secondary	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	No
Secondary	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	No
Secondary	Anger	Measured by State Trait Anger Scale.	Assessed at baseline, after treatment period (16 weeks), Week 28 and 52 after inclusion	No
Secondary	Hopelessness	Measured by Becks Hopelessness Scale.	Assessed at baseline, after treatment period (16 weeks), Week 28 and 52 after inclusion.	No
Secondary	Self Esteem	Measured by Rosenbergs Self esteem Scale (RSE).	Assessed at baseline, after treatment period (16 weeks), Week 28 and 52 after inclusion	No
Secondary	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.	No