Dialectical Behavior Therapy for men with borderline personality disorder and antisocial behavior
| ISRCTN | ISRCTN23976022 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN23976022 |
| Protocol serial number | N/A |
| Sponsor | Swedish Prison and Probation Service (Sweden) |
| Funder | Swedish Prison and Probation Service (Sweden) |
- 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
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
Scientific
Division of Psychology
Karolinska Institutet
Nobels väg 9-11
Solna
171 65
Sweden
Study information
| Primary study design | Interventional |
|---|---|
| Study design | Intervention study with within-subjects design |
| Secondary study design | Other |
| 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(s) |
1. Structured interviews collecting data on earlier antisocial behaviors using the Timeline Follow Back Method |
| Key secondary outcome measure(s) |
Self-ratings: |
| Completion date | 31/12/2016 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Sex | Male |
| Target sample size at registration | 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
171 65
Sweden
Results and Publications
| Individual participant data (IPD) Intention to share | No |
|---|---|
| IPD sharing plan summary | 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.
