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

Not Applicable

Completed

• Conditions: Suicide; Borderline Personality Disorder
• Interventions: Behavioral: CAMS; Behavioral: DBT

• Registration Number: NCT01512602
• Lead Sponsor: Mental Health Services in the Capital Region, Denmark

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2011-12-21
• Study Start: 2012-01
• Study First Submitted QC: 2012-01-14
• Study First Posted: 2012-01-19
• Primary Completion: 2014-07
• Study Completion: 2014-07
• Status Verified: 2015-04
• Last Update Submitted: 2015-04-25
• Last Update Posted: 2015-04-28

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 108

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

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
CAMS	CAMS	Collaborative Assessment and Management of Suicidality, CAMS-informed supportive psychotherapy
Dialectical Behavior Therapy DBT	DBT	16 weeks DBT-treatment

Primary Outcome Measures

Name	Time	Method
Number of repeated self-harming acts including suicide attempts (change in number of self-harming acts).	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

Name	Time	Method
Suicide related behavior.	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
Depressive symptoms	Assessed at baseline, after treatment period (16 weeks), Week 28 and 52 after inclusion	Measured by HDRS-17 and BDI.
Suicidal ideation	Assessed at baseline, after treatment period (16 weeks), Week 28 and 52 after inclusion	Measured by Beck's Suididal Ideation Scale (SSI-21)
Anger	Assessed at baseline, after treatment period (16 weeks), Week 28 and 52 after inclusion	Measured by State Trait Anger Scale.
Consumptions of services in hospital care.	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.
Severity of borderline personality disorder symptoms.	Assessed at baseline, after treatment period (16 weeks), Week 28 and 52 after inclusion	Measured by Zanarini Borderline Personality Scale.
Hopelessness	Assessed at baseline, after treatment period (16 weeks), Week 28 and 52 after inclusion.	Measured by Becks Hopelessness Scale.
Self Esteem	Assessed at baseline, after treatment period (16 weeks), Week 28 and 52 after inclusion	Measured by Rosenbergs Self esteem Scale (RSE).
Impulsivity	Assessed at baseline, after treatment period (16 weeks), Week 28 and 52 after inclusion	Measured by Barratts Impulsivity Scale (BIS-11)

Trial Locations

Locations (1)

Mental Health Services, Research Unit, Bispebjerg; 🇩🇰 Copenhagen NV., Denmark