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Trial registered on ANZCTR


Registration number
ACTRN12612001187831
Ethics application status
Approved
Date submitted
8/11/2012
Date registered
12/11/2012
Date last updated
7/07/2020
Date data sharing statement initially provided
7/07/2020
Date results information initially provided
7/07/2020
Type of registration
Retrospectively registered

Titles & IDs
Public title
Exploring Dialectical Behaviour Therapy vs Conversational Model in the treatment of Borderline Personality Disorder: A randomised clinical trial
Scientific title
Randomised clinical trial of Dialectical Behaviour Therapy compared to Conversational Model in the treatment of Borderline Personality Disorder in reducing parasuicidal behaviour and depression.
Secondary ID [1] 281508 0
Nil
Universal Trial Number (UTN)
Nil
Trial acronym
Nil
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Borderline Personality Disorder 287778 0
Condition category
Condition code
Mental Health 288127 288127 0 0
Psychosis and personality disorders
Public Health 288128 288128 0 0
Health service research

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Intervention A: Dialectical Behaviour Therapy (DBT)
The participants will take part in a manualised treatment that combines treatment strategies from behavioural, cognitive and supportive psychotherapies. It will include weekly individual therapy for two months, followed by concurrent weekly individual and group therapy for 12 months. The individual DBT therapy session will be for approximately one hour per week and apply directive, problem-orientated techniques (including behavioural skill training, contingency management, and cognitive modification) balanced with supportive techniques such as reflection, and acceptance. The emphasis is on teaching participants how to manage emotional experiences.
The group therapy will meet once each week for two and a half hours and follow a psycho-educational format. Behavioural skills in three main areas will be taught in three modules as follows: interpersonal effectiveness, distress tolerance, and emotion regulation skills. Each module will be preceded by a two-week focus on Mindfulness, which is the core skill taught over the entire group. The group will include the teaching and application of skills, and the practice of them between classes.

Intervention B: Conversational Model (CM)
The participants will have twice weekly individual therapy for fourteen months. The individual therapy will be for approximately one hour per session and will be nondirective. The focus will be on understanding the patient’s emotional experience and actively describing that back to the patient. The therapist actively looks for subtle signs of emotionally misunderstanding the patient, leading to mutual self-reflection and repair of the moment of disconnection in the therapeutic relationship. High value is placed on the patient’s real experience (as against socially acceptable experience) and the development of an authentic personal narrative. The patient is encouraged to find links between the maladaptive relationship patterns they have developed in their current social world and the relationship pattern they have with the therapist (and possibly, but not necessarily, the links with their childhood relationships).
Intervention code [1] 286025 0
Treatment: Other
Intervention code [2] 286026 0
Behaviour
Comparator / control treatment
DBT & CM are both active treatments and are both considered to have equal weight in the study for comparator purposes.
Control group
Active

Outcomes
Primary outcome [1] 288329 0
Primary Outcome 2: Depression scores as measured by Beck Depression Inventory II (BDI-II)
Timepoint [1] 288329 0
Timepoint: at baseline, 7 months (mid-treatment), 14 months (post-treatment), 26 months (1 year follow-up), 38 months (2 year follow-up) and 74 months (5 year follow-up).
Primary outcome [2] 288391 0
Primary Outcome 1: Parasuicidal behaviour (including suicide attempts and non-suicidal self-injury) as measured by information from the following measures:
a. Suicide Attempt Self-Injury Interview Count (SASII)
b. Borderline Personality Disorder Severity Index (BPDSI)
c. Structured Clinical Interview for Axis II Disorders (SCID-II)
Timepoint [2] 288391 0
Timepoint: at baseline, 7 months (mid-treatment), 14 months (post-treatment), 26 months (1 year follow-up), 38 months (2 year follow-up) and 74 months (5 year follow-up).
Secondary outcome [1] 299875 0
Secondary Outcome 1: Number and severity of BPD symptoms as measured by Borderline Personality Disorder Severity Index (BPDSI)
Timepoint [1] 299875 0
Timepoint: at baseline, 14 months (post-treatment), 26 months (1 year follow-up), 38 months (2 year follow-up) and 74 months (5 year follow-up).
Secondary outcome [2] 299876 0
Secondary Outcome 2: Interpersonal problems as measured by the Inventory of Interpersonal Problems (IIP)
Timepoint [2] 299876 0
Timepoint: at baseline, 7 months (mid-treatment), 14 months (post-treatment), 26 months (1 year follow-up), 38 months (2 year follow-up) and 74 months (5 year follow-up).
Secondary outcome [3] 299877 0
Secondary Outcome 3: Mindfulness skills as measured by the Kentucky Inventory of Mindfulness Scale (KIMS)
Timepoint [3] 299877 0
Timepoint: at baseline, 7 months (mid-treatment), 14 months (post-treatment), 26 months (1 year follow-up), 38 months (2 year follow-up) and 74 months (5 year follow-up).
Secondary outcome [4] 299878 0
Secondary Outcome 4: Dissociation as measured by the Dissociative Experiences Scale (DES)
Timepoint [4] 299878 0
Timepoint: at baseline, 7 months (mid-treatment), 14 months (post-treatment), 26 months (1 year follow-up), 38 months (2 year follow-up) and 74 months (5 year follow-up).
Secondary outcome [5] 299879 0
Secondary Outcome 5: Emotion regulation as measured by the Difficulties in Emotion Regulation Scale (DERS)
Timepoint [5] 299879 0
Timepoint: at baseline, 7 months (mid-treatment), 14 months (post-treatment), 26 months (1 year follow-up), 38 months (2 year follow-up) and 74 months (5 year follow-up).
Secondary outcome [6] 299880 0
Secondary Outcome 6: Sense of self as measured by the Sense of Self Inventory (SSI)
Timepoint [6] 299880 0
Timepoint: at baseline, 7 months (mid-treatment), 14 months (post-treatment), 26 months (1 year follow-up), 38 months (2 year follow-up) and 74 months (5 year follow-up).

Eligibility
Key inclusion criteria
Meet the diagnostic criteria for BPD as measured by SCID-II interview
Minimum of three episodes of parasuicidal behaviour in the past 12 months
Between 18-65 years of age
Fluent in English
Live within an hour’s drive of the treatment centre
Minimum age
18 Years
Maximum age
65 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Disabling organic conditions
Acute psychotic illness
Antisocial behaviour that poses a significant threat to staff
Developmental disability
Living more than one hour's drive from Newcastle
Unable to speak or read English
Prior treatment with DBT or Conversational Model
Drug or Alcohol dependence (eligible for entry once no longer meet criteria for dependence)

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Participants will be assessed by a psychiatrist to determine whether they meet criteria for BPD. If they meet criteria, they will be invited to talk with the Research Assistant who will explain the study and ask whether they would like to participate. If they provide consent, they will complete the baseline assessment and then receive a sealed, opaque envelope with their randomisation status. It will be explained to the participants why the assessor needs to be blind and they will be asked not to discuss the type of treatment they receive with the assessor.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Blocked and stratified randomisation using randomisation created by computer software. Stratified by gender and anti-depressant use.
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
Phase
Not Applicable
Type of endpoint/s
Efficacy
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
12/04/2007
Actual
12/04/2007
Date of last participant enrolment
Anticipated
Actual
30/04/2013
Date of last data collection
Anticipated
Actual
23/07/2019
Sample size
Target
162
Accrual to date
Final
162
Recruitment in Australia
Recruitment state(s)
NSW

Funding & Sponsors
Funding source category [1] 286289 0
Self funded/Unfunded
Name [1] 286289 0
Country [1] 286289 0
Primary sponsor type
Government body
Name
Hunter New England Local Health District
Address
PO Box 833
Newcastle
NSW
2300
Country
Australia
Secondary sponsor category [1] 285082 0
University
Name [1] 285082 0
Centre for Translational Neuroscience and Mental Health
Address [1] 285082 0
Centre for Translational Neuroscience and Mental Health
HNELHD & University of Newcastle
PO Box 833
Newcastle
NSW
2300
Country [1] 285082 0
Australia

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 288365 0
Hunter New England Human Research Ethics Committee
Ethics committee address [1] 288365 0
Hunter New England Human Research Ethics Committee
Hunter New England Health
Locked Bag 1
New Lambton NSW 2305
Ethics committee country [1] 288365 0
Australia
Date submitted for ethics approval [1] 288365 0
Approval date [1] 288365 0
19/12/2006
Ethics approval number [1] 288365 0
06/12/13/5.11

Summary
Brief summary
Approximately 11% of all psychiatric outpatients and 19% of psychiatric inpatients meet the criteria for Borderline Personality Disorder (BPD). People with this disorder are high utilisers of mental health services and medical services as their condition often involves problems with interpersonal relationships, impulsivity in self-damaging areas such as substance abuse and reckless driving, recurrent suicidal threats and self-harming or self-mutilating behaviours. Approximately 9% of all individuals with BPD commit suicide.

DBT has become the gold standard of psychotherapeutic treatment of BPD. Results across a number of trials have consistently shown significant reductions in suicidal and self-mutilating behaviours as well as improvement in quality of life. To date, there have been very few RCTs comparing DBT to other active treatments and very few trials conducted in real world settings. This trial compares DBT with CM, a psychodynamic model, developed specifically for treatment of BPD that has some empirical support, but has not been evaluated against another active treatment. It is hypothesised that DBT will be more effective at reducing self-harm and suicidal behaviour than CM, but less effective at reducing depression.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 34929 0
Dr Carla Walton
Address 34929 0
Centre for Psychotherapy
Hunter New England Mental Health Service
PO Box 833
Newcastle NSW 2300
Australia
Country 34929 0
Australia
Phone 34929 0
+61 02 4924 6820
Fax 34929 0
Email 34929 0
[email protected]
Contact person for public queries
Name 18176 0
Dr Dr Carla Walton
Address 18176 0
Centre for Psychotherapy,
Hunter New England Mental Health Service
PO Box 833,
Newcastle NSW 2300
Country 18176 0
Australia
Phone 18176 0
+61 2 4924 6820
Fax 18176 0
+61 2 4924 6801
Email 18176 0
[email protected]
Contact person for scientific queries
Name 9104 0
Dr Dr Carla Walton
Address 9104 0
Centre for Psychotherapy,
Hunter New England Mental Health Service
PO Box 833,
Newcastle NSW 2300
Country 9104 0
Australia
Phone 9104 0
+61 2 4924 6820
Fax 9104 0
+61 2 4924 6801
Email 9104 0
[email protected]

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
No/undecided IPD sharing reason/comment
Participants did not provide consent for this.


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

Documents added manually
No documents have been uploaded by study researchers.

Documents added automatically
SourceTitleYear of PublicationDOI
EmbaseA randomised trial of dialectical behaviour therapy and the conversational model for the treatment of borderline personality disorder with recent suicidal and/or non-suicidal self-injury: An effectiveness study in an Australian public mental health service.2020https://dx.doi.org/10.1177/0004867420931164
N.B. These documents automatically identified may not have been verified by the study sponsor.