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

ISRCTN	ISRCTN23976022
DOI	https://doi.org/10.1186/ISRCTN23976022
Secondary identifying numbers	N/A

Submission date: 02/06/2014
Registration date: 11/09/2014
Last edited: 25/06/2020

Recruitment status: No longer recruiting
Overall study status: Completed
Condition category: Mental and Behavioural Disorders

Prospectively registered

Protocol

Statistical analysis plan

Results

Individual participant data

Plain English summary of protocol

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

Contact information

Dr Pia Enebrink
Scientific

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

Study information

Study design	Intervention study with within-subjects design
Primary study design	Interventional
Secondary study design	Other
Study setting(s)	Hospital
Study type	Treatment
Scientific title	Effectiveness trial of Dialectical Behavior Therapy for men with borderline personality disorder and antisocial behavior
Study objectives	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(s)	The regional ethical committee in Stockholm, 06/03/2012, ref. 2012/91-31/4
Health condition(s) or problem(s) studied	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
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	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 study start date	09/12/2013
Completion date	31/12/2016

Eligibility

Participant type(s)	Patient
Age group	Adult
Sex	Male
Target number of participants	32
Total final enrolment	30
Key inclusion criteria	Men with borderline personality disorder and antisocial behavior
Key exclusion criteria	1. Psychotic disorder 2. Severe substance abuse 3. Autistic disorders
Date of first enrolment	09/12/2013
Date of final enrolment	31/12/2016

Locations

Countries of recruitment

Sweden

Study participating centre

Division of Psychology

Solna
171 65
Sweden

Sponsor information

Swedish Prison and Probation Service (Sweden)
Government

Kriminalvården
601 80 Norrköping
Norrköping
601 80
Sweden

"ROR"	https://ror.org/04030gz13

Funders

Funder type

Government

Swedish Prison and Probation Service (Sweden)

No information available

Results and Publications

Intention to publish date
Individual participant data (IPD) Intention to share	No
IPD sharing plan summary	Not provided at time of registration
Publication and dissemination plan	Not provided at time of registration
IPD sharing plan

Study outputs

Output type	Details	Date created	Date added	Peer reviewed?	Patient-facing?
Results article	results	01/02/2020	25/06/2020	Yes	No

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.