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Efficacy of Dialectical Behavior Therapy Versus CAMS-informed Supportive Psychotherapy on Self Harming Behavior (DiaS)
This study has been completed.
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
ClinicalTrials.gov Identifier:
NCT01512602
First received: December 21, 2011
Last updated: April 25, 2015
Last verified: April 2015
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Purpose
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 | Intervention |
|---|---|
| Borderline Personality Disorder Suicide | Behavioral: DBT Behavioral: CAMS |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Intervention Model: Parallel Assignment Masking: Double Blind (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. |
Resource links provided by NLM:
Further study details as provided by Merete Nordentoft, Mental Health Services in the Capital Region, Denmark:
Primary Outcome Measures:
- 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:
- Depressive symptoms [ Time Frame: Assessed at baseline, after treatment period (16 weeks), Week 28 and 52 after inclusion ]Measured by HDRS-17 and BDI.
- Impulsivity [ Time Frame: Assessed at baseline, after treatment period (16 weeks), Week 28 and 52 after inclusion ]Measured by Barratts Impulsivity Scale (BIS-11)
- 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.
- 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)
- 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.
- Anger [ Time Frame: Assessed at baseline, after treatment period (16 weeks), Week 28 and 52 after inclusion ]Measured by State Trait Anger Scale.
- Hopelessness [ Time Frame: Assessed at baseline, after treatment period (16 weeks), Week 28 and 52 after inclusion. ]Measured by Becks Hopelessness Scale.
- 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).
- 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
| Enrollment: | 108 |
| Study Start Date: | January 2012 |
| Study Completion Date: | July 2014 |
| Primary Completion Date: | July 2014 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
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
|
Eligibility| Ages Eligible for Study: | 18 Years to 65 Years (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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study.
To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below.
For general information, see Learn About Clinical Studies.
Please refer to this study by its ClinicalTrials.gov identifier: NCT01512602
Please refer to this study by its ClinicalTrials.gov identifier: NCT01512602
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):
| Responsible Party: | Merete Nordentoft, Professor, MD, Mental Health Services in the Capital Region, Denmark |
| ClinicalTrials.gov Identifier: | NCT01512602 History of Changes |
| Other Study ID Numbers: |
RHP-DiaS-002 |
| Study First Received: | December 21, 2011 |
| Last Updated: | April 25, 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 |
ClinicalTrials.gov processed this record on July 21, 2017