Condition category
Mental and Behavioural Disorders
Date applied
Date assigned
Last edited
Retrospectively registered
Overall trial status
Recruitment status
No longer recruiting
Publication status

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.

Trial website

Contact information



Primary contact

Dr Pia Enebrink


Contact details

Division of Psychology
Karolinska Institutet
Nobels väg 9-11
171 65

Additional identifiers

EudraCT number number

Protocol/serial number


Study information

Scientific title

Effectiveness trial of Dialectical Behavior Therapy for men with borderline personality disorder and antisocial behavior


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


Secondary study design


Trial setting


Trial type


Patient information sheet


Borderline personality disorder


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



Not Applicable

Drug names

Primary outcome measure

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

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


Overall trial end date


Reason abandoned (if study stopped)


Participant inclusion criteria

Men with borderline personality disorder and antisocial behavior

Participant type


Age group




Target number of participants


Total final enrolment


Participant exclusion criteria

1. Psychotic disorder
2. Severe substance abuse
3. Autistic disorders

Recruitment start date


Recruitment end date



Countries of recruitment


Trial participating centre

Division of Psychology
171 65

Sponsor information


Swedish Prison and Probation Service (Sweden)

Sponsor details

601 80 Norrköping
601 80

Sponsor type




Funder type


Funder name

Swedish Prison and Probation Service (Sweden)

Alternative name(s)

Funding Body Type

Funding Body Subtype


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

Basic results (scientific)

Publication list

2020 results in (added 25/06/2020)

Publication citations

Additional files

Editorial Notes

25/06/2020: The following changes were made to the trial record: 1. Publication reference added. 2. The total final enrolment was added.