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

Study Overview
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Brief Summary
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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.

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

Conditions
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Borderline Personality Disorder, Suicide

Intervention / Treatment
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* Behavioral: DBT
* Behavioral: CAMS


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 65 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Dialectical Behavior Therapy DBT<br>16 weeks DBT-treatment | Behavioral: DBT<br>* 16 weeks DBT treatment<br>|
| Active Comparator: CAMS<br>Collaborative Assessment and Management of Suicidality, CAMS-informed supportive psychotherapy | Behavioral: CAMS<br>* CAMS-informed psychotherapy<br>|

What is the study measuring?
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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. | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Borderline Personality Disorder traits, Suicide prevention, Self-harm, Dialectical Behavior Therapy, DBT, Collaborative Assessment and Management of Suicidology, CAMS