Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12618000477224
Ethics application status
Approved
Date submitted
21/03/2018
Date registered
3/04/2018
Date last updated
11/03/2020
Date data sharing statement initially provided
4/03/2019
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

Intervention/exposure
Study type
Interventional
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
Behaviour
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
Active

Outcomes
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

Eligibility
Key inclusion criteria
Formal diagnosis of Borderline Personality Disorder
Minimum age
18 Years
Maximum age
65 Years
Sex
Both males and females
Can healthy volunteers participate?
No
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
Treatment
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
Parallel
Other design features
Nil
Phase
Not Applicable
Type of endpoint/s
Efficacy
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
Recruitment status
Recruiting
Date of first participant enrolment
Anticipated
16/04/2018
Actual
3/07/2018
Date of last participant enrolment
Anticipated
30/06/2020
Actual
Date of last data collection
Anticipated
30/06/2021
Actual
Sample size
Target
128
Accrual to date
121
Final
Recruitment in Australia
Recruitment state(s)
NSW
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
Country [1] 296558 0
Australia
Primary sponsor type
Hospital
Name
Illawarra Shoalhaven Local Health District
Address
1 Atchison St
Wollongong
NSW 2500
Country
Australia
Secondary sponsor category [1] 295524 0
Other
Name [1] 295524 0
Project Air Strategy
Address [1] 295524 0
School of Psychology
Building 22
School of Psychology
Northfields Ave,
Wollongong,
NSW 2522
Country [1] 295524 0
Australia

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 297774 0
University of Wollongong and Illawarra Shoalhaven LHD Health and Medical HREC
Ethics committee address [1] 297774 0
Ethics committee country [1] 297774 0
Australia
Date submitted for ethics approval [1] 297774 0
22/08/2017
Approval date [1] 297774 0
26/09/2017
Ethics approval number [1] 297774 0
HREC/17/WGONG/98

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
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
Australia
Phone 75074 0
+61 2 4221 4407
Fax 75074 0
Email 75074 0
[email protected]
Contact person for public queries
Name 75075 0
Judy Pickard
Address 75075 0
Northfields Clinic, School of Psychology
Building 22
University of Wollongong
NSW 2522
Country 75075 0
Australia
Phone 75075 0
+61 2 4221 4407
Fax 75075 0
Email 75075 0
[email protected]
Contact person for scientific queries
Name 75076 0
Brin Grenyer
Address 75076 0
Project Air Strategy
School of Psychology
Building 22
University of Wollongong
NSW 2522
Country 75076 0
Australia
Phone 75076 0
+61 2 4221 3474
Fax 75076 0
Email 75076 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
To maintain client confidentiality no individual data will be shared.


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
EmbaseAssessing the efficacy of a stepped-care group treatment programme for borderline personality disorder: study protocol for a pragmatic trial.2021https://dx.doi.org/10.1186/s13063-021-05327-0
N.B. These documents automatically identified may not have been verified by the study sponsor.