Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12616000236493
Ethics application status
Approved
Date submitted
15/02/2016
Date registered
22/02/2016
Date last updated
24/01/2017
Type of registration
Retrospectively registered

Titles & IDs
Public title
Effectiveness of Dialectical Behaviour Therapy (DBT) Group Skills Training for Borderline Personality Disorder (BPD) in Community Mental Health
Scientific title
Effectiveness of Dialectical Behaviour Therapy (DBT) Group Skills Training for Borderline Personality Disorder (BPD) in Community Mental Health
Secondary ID [1] 288535 0
None
Universal Trial Number (UTN)
U1111-1179-6444
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Borderline Personality Disorder 297634 0
Condition category
Condition code
Mental Health 297825 297825 0 0
Psychosis and personality disorders

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Participants will attend a 25 week DBT skills training group led by two mental health clinicians (nursing and allied health). The group runs for two hours each week. The focus of the group is skills acquisition - it is not a 'process' group to discuss feelings or recent distressing episodes. Homework is required to assist in practising new skills and monitoring progress. The program consists of four components:
Mindfulness skills assist in learning to focus attention on the present moment. Participants learn to observe and describe experiences, effectively and without judgement.
Emotion Regulation focuses on skills to moderate emotions and have more effective emotional experiences. Participants are taught to understand and label emotional experiences, decrease vulnerability to emotional thinking, and overcome mood dependent actions.
Distress Tolerance teaches participants to accept themselves, their emotions and the current situation, to survive crises and avoid harmful behaviour.
Interpersonal Effectiveness focuses on interpersonal problem solving and effective communication, helping participants to maintain positive relationships and reduce overwhelming emotions.
Participants are required to maintain minimum fortnightly contact with their individual case manager, to notify DBT facilitators if they are unable to attend, and to adhere to group rules about confidentiality and behaviour in group. Attendance is monitored using a registered of attendance.
Intervention code [1] 293911 0
Behaviour
Intervention code [2] 293973 0
Treatment: Other
Comparator / control treatment
A treatment as usual (TAU) control is employed, consisting of individual case management by a mental health clinician. Care, including the type of support employed and the frequency and duration of sessions, is determined by the treating clinician based on individual client needs.
Control group
Active

Outcomes
Primary outcome [1] 297352 0
Change in borderline-related symptomology measured by Borderline Symptom List 23 item version (BSL23)
Timepoint [1] 297352 0
Baseline, and at 25 weeks after commencement of intervention
Secondary outcome [1] 320788 0
Change in self-reported quality of life, measured by World Health Organisation Quality of Life BREF version (WHOQOLBREF)
Timepoint [1] 320788 0
Baseline, and at 25 weeks after commencement of intervention
Secondary outcome [2] 320789 0
Change in client satisfaction with services, measured by Client Satisfaction Questionnaire (CSQ)
Timepoint [2] 320789 0
25 weeks after commencement of intervention
Secondary outcome [3] 320790 0
Change in utilisation of health services, defined as number of mental health emergency presentations, number of mental health hospital admissions, and total days of admission, assessed by review of medical records.
Timepoint [3] 320790 0
6 months prior to commencement of intervention and 6 months following completion of intervention.

Eligibility
Key inclusion criteria
Borderline Personality Disorder
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Cognitive impairment
Intellectual disability
Narcissistic Personality Disorder
Antisocial Personality Disorder

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)
Randomised allocation by sealed opaque envelopes
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Open (masking not 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
Actual
13/01/2015
Date of last participant enrolment
Anticipated
7/07/2016
Actual
7/07/2016
Date of last data collection
Anticipated
Actual
22/12/2016
Sample size
Target
60
Accrual to date
Final
42
Recruitment in Australia
Recruitment state(s)
SA
Recruitment hospital [1] 5271 0
Mount Gambier and Districts Health Service - Mount Gambier
Recruitment postcode(s) [1] 12734 0
5290 - Mount Gambier

Funding & Sponsors
Funding source category [1] 292885 0
Government body
Name [1] 292885 0
Country Health SA Local Health Network Mental Health
Country [1] 292885 0
Australia
Primary sponsor type
University
Name
The University of Adelaide
Address
Adelaide, South Australia 5005
Country
Australia
Secondary sponsor category [1] 291629 0
Government body
Name [1] 291629 0
Country Health SA Local Health Network Mental Health
Address [1] 291629 0
PO Box 267
Mount Gambier SA 5290
Country [1] 291629 0
Australia

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 294385 0
SA Health Human Research Ethics Committee
Ethics committee address [1] 294385 0
Ethics committee country [1] 294385 0
Australia
Date submitted for ethics approval [1] 294385 0
Approval date [1] 294385 0
08/12/2014
Ethics approval number [1] 294385 0
HREC-14-SAH-176

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes
Attachments [1] 761 761 0 0
/AnzctrAttachments/370119-approval letter HREC-14-SAH-176.pdf

Contacts
Principal investigator
Name 63534 0
Ms Brooke Packham
Address 63534 0
c/o Bordertown Community Health
PO Box 196
Bordertown SA 5268
Country 63534 0
Australia
Phone 63534 0
+61887211507
Fax 63534 0
+61887211508
Email 63534 0
[email protected]
Contact person for public queries
Name 63535 0
Brooke Packham
Address 63535 0
c/o Bordertown Community Health
PO Box 196
Bordertown SA 5268
Country 63535 0
Australia
Phone 63535 0
+61887211507
Fax 63535 0
+61887211508
Email 63535 0
[email protected]
Contact person for scientific queries
Name 63536 0
Brooke Packham
Address 63536 0
c/o Bordertown Community Health
PO Box 196
Bordertown SA 5268
Country 63536 0
Australia
Phone 63536 0
+61887211507
Fax 63536 0
+61887211508
Email 63536 0
[email protected]

No information has been provided regarding IPD availability


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
No additional documents have been identified.