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Trial registered on ANZCTR

Registration number
Ethics application status
Date submitted
Date registered
Date last updated
Date data sharing statement initially provided
Type of registration
Prospectively registered

Titles & IDs
Public title
Assessing the efficacy of a stepped care treatment program for Borderline Personality Disorder
Scientific title
A randomised control trial assessing the efficacy of stepped care psychological treatment versus treatment as usual for Borderline Personality Disorder
Secondary ID [1] 292028 0
Nil known
Universal Trial Number (UTN)
Nil Known
Trial acronym
Nil known
Linked study record
Nil known

Health condition
Health condition(s) or problem(s) studied:
Borderline Personality Disorder 303419 0
Condition category
Condition code
Mental Health 302831 302831 0 0
Psychosis and personality disorders

Study type
Description of intervention(s) / exposure
The intervention is a stepped care group treatment program. Following diagnostic assessment confirming trial eligibility participants will then be randomised to either stepped care group treatment or tailored individual treatment. The stepped care group treatment will involve two phases: an initial 12 week phase, followed by an extended 16 week phase. Not all participants will proceed from the initial to the extended phase. Criteria for continuing to the extended phase is continuing to meet diagnostic criteria for BPD (> 4 criteria) or severity on GAF < 65 at completion of the initial phase. The group intervention is a skills training (GST) program. The first phase of group treatment will involve 12 consecutive weekly, 2 hour sessions. The second phase of group treatment will provide 1 x 2 hour sessions for 16 consecutive weeks. The groups will be facilitated by 2 psychologists. The GST program is a skills based therapy that includes four modules: mindfulness (focusing on the 'here and now'), crisis coping skills, skills in how to identify and manage emotions and skills for improving interpersonal communication and relationship building.
Intervention code [1] 298157 0
Treatment: Other
Intervention code [2] 298158 0
Comparator / control treatment
Following the brief intervention sessions the comparison group will receive "treatment as usual". This will be a tailored treatment that incorporates the current treatment options provided by the community mental health service, for example: referral to individual psychology, psychiatric consultation and medication review and case coordination .
Control group

Primary outcome [1] 302224 0
Severity of BPD assessed by number of criteria meet of the structured Clinical Interview for DSM-5 Disorders for Personality Disorders (SCID-5-PD).
Timepoint [1] 302224 0
Intake assessment and twelve months post intake.
Primary outcome [2] 302225 0
Change in number of presentations to the emergency department collected through data linkage to medical records.
Timepoint [2] 302225 0
Intake assessment and twelve months post intake.
Primary outcome [3] 305302 0
Change in duration of admissions collected through data linkage to medical records
Timepoint [3] 305302 0
Intake assessment and twelve months post intake.
Secondary outcome [1] 340027 0
Change in overall functioning measured by the Global Assessment of Functioning (GAF).
Timepoint [1] 340027 0
Intake assessment and twelve months post intake

Key inclusion criteria
Formal diagnosis of Borderline Personality Disorder
Minimum age
18 Years
Maximum age
65 Years
Both males and females
Can healthy volunteers participate?
Key exclusion criteria
Non English speaking
Acute psychotic disorder
Unable to participate due to current drug and alcohol use
Participant requires a higher level of care than provided in the intervention, e.g. inpatient admission

Study design
Purpose of the study
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Allocation involved contacting the holder of the allocation schedule who was 'off site".
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Computerised sequence will randomly allocate participants to stepped or tailored care. Randomisation will be blocked to ensure severity on the GAF, parasuicidal behaviour, age, and gender are balanced between groups.
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?

Intervention assignment
Other design features
Not Applicable
Type of endpoint(s)
Statistical methods / analysis
Using the sample size calculation method via G Power, in order to produce a medium to large effect with the power of approximately 80% for an independent t-test, each group should have 64 participants, totalling 128 participants.

Similar randomised controlled trials investigating the efficacy of DBT included sample sizes ranging from 27 - 180 (McMain et al, 2009; Tormoen,et al. 2014 & Verheul et al, 2003). The current RCT will adopt a sample size of 128.

Recruitment status
Date of first participant enrolment
Date of last participant enrolment
Date of last data collection
Sample size
Accrual to date
Recruitment in Australia
Recruitment state(s)
Recruitment postcode(s) [1] 16181 0
2500 - Wollongong
Recruitment postcode(s) [2] 22148 0
2560 - Campbelltown

Funding & Sponsors
Funding source category [1] 296558 0
Government body
Name [1] 296558 0
Translational Research Grant Scheme
Address [1] 296558 0
NSW Ministry of Health
73 Miller St
North Sydney
NSW 2060
Country [1] 296558 0
Primary sponsor type
Illawarra Shoalhaven Local Health District
1 Atchison St
NSW 2500
Secondary sponsor category [1] 295524 0
Name [1] 295524 0
Project Air Strategy
Address [1] 295524 0
School of Psychology
Building 22
School of Psychology
Northfields Ave,
NSW 2522
Country [1] 295524 0

Ethics approval
Ethics application status
Ethics committee name [1] 297774 0
University of Wollongong and Illawarra Shoalhaven LHD Health and Medical HREC
Ethics committee address [1] 297774 0
Research Services Office, University of Wollongong
Northfields Avenue, Wollongong NSW 2522
Ethics committee country [1] 297774 0
Date submitted for ethics approval [1] 297774 0
Approval date [1] 297774 0
Ethics approval number [1] 297774 0

Brief summary
People meeting the criteria for Borderline Personality Disorder have a variety of mental health and psychosocial difficulties. The disorder can have a significant burden on the person's partner and family and can lead to high costs to health services if left untreated.. Approximately 10% of clients with Borderline Personality Disorder die by suicide. Costs to the health service include a high number of emergency department presentations and hospital beds occupied by people with this condition. Psychological therapy is the mainstay of treatment of borderline personality disorder; However, the demand for psychological treatment has resulted in excessive waitlists for a high risk cohort.
This study aims to investigate the effectiveness of a stepped care group program compared to tailored individual care.
Trial website
Trial related presentations / publications
Public notes

Principal investigator
Name 75074 0
Dr Judy Pickard
Address 75074 0
Northfields Clinic, School of Psychology
Building 22
University of Wollongong
NSW 2522
Country 75074 0
Phone 75074 0
+61 2 4221 4407
Fax 75074 0
Email 75074 0
Contact person for public queries
Name 75075 0
Dr Judy Pickard
Address 75075 0
Northfields Clinic, School of Psychology
Building 22
University of Wollongong
NSW 2522
Country 75075 0
Phone 75075 0
+61 2 4221 4407
Fax 75075 0
Email 75075 0
Contact person for scientific queries
Name 75076 0
Prof Brin Grenyer
Address 75076 0
Project Air Strategy
School of Psychology
Building 22
University of Wollongong
NSW 2522
Country 75076 0
Phone 75076 0
+61 2 4221 3474
Fax 75076 0
Email 75076 0

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No/undecided IPD sharing reason/comment
To maintain client confidentiality no individual data will be shared.
What supporting documents are/will be available?
No other documents available
Summary results
No Results