Plain English Summary
Background and study aims
Dialectical behavior therapy (DBT) is a psychological treatment that is known to work well for women with borderline personality disorder (BPD). It has been developed from cognitive behavior therapy (CBT) but modified to meet the needs of people with BPD. CBT focuses on helping people change unhelpful ways of thinking and behaving. DBT does this too, but it also encourages people to accept who they are and includes elements of mindfulness, a mind-body approach developed to help people change how they think about experiences and how to reduce feelings of stress and anxiety. However, to date, there has been a lack of DBT-treatment studies looking at how it may help men with BPD being treated in outpatient clinics. Here, we will look at how well DBT performs when treating men with BPD with a history of anti-social behavior. We want to know to what extent 12 months of DBT might reduce suicidal, impulsive and antisocial behaviors, how much it improves psychological well-being and whether it is considered useful by the participants involved. We also want to investigate variables that might influence the effect of the treatment.
Who can participate?
Men with a diagnosis of borderline personality disorder and antisocial behaviors within Stockholm Psychiatry
What does the study involve?
After the diagnosis of BPD has been made, participants are asked to self-record their antisocial and impulsive behaviors for 4 weeks before the treatment starts. They also attend an interview where they recall their antisocial behavior. They then start a 12 month course of DBT therapy, where they learn how to manage their emotional reactions and destructive behaviors. Participants are asked to self-record their antisocial/impulsive behaviors and attend further interviews 6 months after the treatment starts and at the end of treatment.
What are the possible benefits and risks of participating?
All participants receive intensive DBT treatment, which is known to be helpful for women with BPD. Based on earlier studies, we expect the treatment to help most participants reduce their self-harming, impulsive and anti-social behaviors.
Where is the study run from?
The treatment will be conducted at two psychiatric outpatient clinics in Stockholm.
When is the study starting and how long is it expected to run?
December 2013 to December 2016
Who is funding the study?
Swedish Prison and Probation Service (Sweden)
Who is the main contact?
Pia Enebrink, Ph.D.
pia.enebrink@ki.se
Trial website
Additional identifiers
EudraCT number
ClinicalTrials.gov number
Protocol/serial number
N/A
Study information
Scientific title
Effectiveness trial of Dialectical Behavior Therapy for men with borderline personality disorder and antisocial behavior
Acronym
Study hypothesis
1. What effect does Dialectical Behavior Therapy (DBT) have on self-injurious behavior, depression, anxiety, as well as antisocial, criminal behaviors for men with borderline personality disorder?
2. How do participants experience the treatment, and are there any components of the treatment they find particularly helpful?
3. What is the potential cost-effectiveness of the intervention?
4. Which variables predict (moderators), or explain (mediators) the outcome of DBT?
Ethics approval
The regional ethical committee in Stockholm, 06/03/2012, ref. 2012/91-31/4
Study design
Intervention study with within-subjects design
Primary study design
Interventional
Secondary study design
Other
Trial setting
Hospitals
Trial type
Treatment
Patient information sheet
Condition
Borderline personality disorder
Intervention
Dialectical Behavior Therapy. DBT is based on cognitive behavior therapy (CBT) with the addition of acceptance and mindfulness practices. In treatment, participants learn skills to manage their intensive emotional reactions and destructive behaviors. The treatment is characterized by a combination of individual sessions and skills treatment in group and telephone support for the client, and supervision for the therapists. The treatment lasts for 12 months.
Intervention type
Other
Phase
Not Applicable
Drug names
Primary outcome measures
1. Structured interviews collecting data on earlier antisocial behaviors using the Timeline Follow Back Method
2. Daily registration of antisocial behaviors: participants will register antisocial and impulsive behaviors during a 4-week baseline period before treatment starts, as well as throughout the treatment period
3. Swedish National Centre for Crime Prevention, reported offenses
Secondary outcome measures
Self-ratings:
1. Beck Depression Inventory II (BDI)
2. Beck Anxiety Inventory (BAI)
3. Alcohol use disorders identification test (AUDIT)
4. Drug use disorders identification test (DUDIT)
5. Karolinska affective and borderline symptom scale- self rating (KABOSS-S)
6. ASEBA-ASR (Adult Behavior Checklist)
7. DBT-skills rating scale
8. Health and occupation survey
Questionnaire for relatives:
1. ASEBA-ABCL (Adult Behavior Checklist)
Therapist ratings:
1. Attendance of therapy sessions
2. Homework completion
Overall trial start date
09/12/2013
Overall trial end date
31/12/2016
Reason abandoned
Eligibility
Participant inclusion criteria
Men with borderline personality disorder and antisocial behavior
Participant type
Patient
Age group
Adult
Gender
Male
Target number of participants
32
Participant exclusion criteria
1. Psychotic disorder
2. Severe substance abuse
3. Autistic disorders
Recruitment start date
09/12/2013
Recruitment end date
31/12/2016
Locations
Countries of recruitment
Sweden
Trial participating centre
Division of Psychology
Solna
171 65
Sweden
Funders
Funder type
Government
Funder name
Swedish Prison and Probation Service (Sweden)
Alternative name(s)
Funding Body Type
Funding Body Subtype
Location
Results and Publications
Publication and dissemination plan
Not provided at time of registration
Intention to publish date
Participant level data
Not provided at time of registration
Results - basic reporting
Publication summary