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Trial registered on ANZCTR


Registration number
ACTRN12618001687280
Ethics application status
Approved
Date submitted
13/09/2018
Date registered
12/10/2018
Date last updated
20/09/2019
Date data sharing statement initially provided
20/09/2019
Type of registration
Retrospectively registered

Titles & IDs
Public title
A Dismantling Study of Dialectical Behaviour Therapy (DBT) Skills: Investigating the Effectiveness of Distress Tolerance, Emotion Regulation, and Interpersonal Effectiveness Skills Groups
Scientific title
A Dismantling Study of Dialectical Behaviour Therapy (DBT) Skills: Investigating the Effectiveness of Distress Tolerance, Emotion Regulation, and Interpersonal Effectiveness Skills Groups in Routine Adult Public Mental Health Settings in Queensland, Australia
Secondary ID [1] 295885 0
None
Universal Trial Number (UTN)
U1111-1220-4343
Trial acronym
DBT
Linked study record
None

Health condition
Health condition(s) or problem(s) studied:
Borderline Personality Disorder 309645 0
Condition category
Condition code
Mental Health 308448 308448 0 0
Psychosis and personality disorders

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
BRIEF NAME
Dialectical Behaviour Therapy (DBT).
WHY
DBT is an efficacious treatment for reducing suicidality and nonsuicidal self-injury among patients with Borderline Personality Disorder (BPD).
WHAT
In the standard DBT model, DBT skills and strategies are taught throughout 6-12 months of weekly 2.5-hour skills groups, weekly one-hour individual therapy sessions, between-session phone coaching, and a weekly consultation group for therapists. Standard DBT consists of three modules - Distress Tolerance, Emotion Regulation, and Interpersonal Effectiveness. Distress Tolerance module is 8 weeks, Emotion Regulation Module is 10 weeks and Interpersonal Effectiveness Module is 7 weeks.
PROCEDURES
The study involves patients of three adult mental health services across five hospitals in Queensland, who have a diagnosis of BPD, and who are completing standard DBT. We will administer outcome questionnaires to participants at five time-points.
This is a controlled trial with three active arms and one control group.
Arm 1
Princess Alexandra Hospital
Logan Hospital
Arm 2
Royal Brisbane and Women's Hospital Group 1
Royal Brisbane and Women's Hospital Group 2
Note - participants are allocated to the two RBWH groups based on capacity in each group as well as client preference for group day and time (Group 1 runs on a Wednesday, Group 2 runs on a Thursday).
Arm 3
The Prince Charles Hospital
Caboolture Hospital
WHO
Psychologists, social workers and mental health nurses who have been intensively trained in delivering standard DBT.
MODE OF DELIVERY
Face-to-face
NUMBER OF TIMES
DBT is delivered twice per week for six months.
Data are collected at five time-points:
Diagnostic and suitability assessment
Time 1: prior to commencing treatment
Time 2: following completion of the first module of DBT
Time 3: following completion of the second module of DBT
Time 4: following completion of the third module of DBT.
LOCATIONS
Princess Alexandra Hospital
Logan Hospital
Royal Brisbane and Women's Hospital
The Prince Charles Hospital
Caboolture Hospital
ADHERENCE
For group DBT sessions, adherence will be measured by group facilitators monitoring their own adherence utilising eight-item adherence checklists developed for this study; and 10% of skills groups will be independently coded via live observation by an intensively trained DBT clinician.
Intervention code [1] 312415 0
Behaviour
Comparator / control treatment
The control group comprises subjects on the wait-list to participate in DBT at the Royal Brisbane and Women's Hospital. This will involve standard care. For the purposes of this study, standard care varies depending upon whatever care the subject is receiving at the time of referral - this can range from no structured care, follow up support calls from the acute care team, regular sessions with a private psychologist or psychiatrist, support from an NGO, or any other combination of care. There is no restriction on the care the wait-list subjects receive, and they are not actively followed up by the RBWH. The subjects in the control group are offered the intervention when a place becomes available in one of the groups. This is usually a wait of at least 2 months, but can be up to 6 months.
Control group
Active

Outcomes
Primary outcome [1] 307431 0
Distress tolerance skills as measured by the DBT Ways of Coping Checklist (DBT WoCCL)
Timepoint [1] 307431 0
At assessment of suitability for DBT program
Time 1 - day of completion of first module of DBT
Time 2 - day of completion of second module of DBT
Time 3 - day of completion of third module of DBT
Primary outcome [2] 307432 0
Emotion regulation skills as measured by the Disorders of Emotion Regulation Scale (DERS)
Timepoint [2] 307432 0
At assessment of suitability for DBT program
Time 1 - day of completion of first module of DBT
Time 2 - day of completion of second module of DBT
Time 3 - day of completion of third module of DBT
Primary outcome [3] 307433 0
Interpersonal effectiveness skills as measured by the Inventory of Interpersonal Problems-32 (IIP-32)
Timepoint [3] 307433 0
At assessment of suitability for DBT program
Time 1 - day of completion of first module of DBT
Time 2 - day of completion of second module of DBT
Time 3 - day of completion of third module of DBT
Secondary outcome [1] 351879 0
Borderline Personality Disorder (BPD) symptoms as measured by the Borderline Symptom List-23 (BSL-23)
Timepoint [1] 351879 0
At assessment of suitability for DBT program
Time 1 - day of completion of first module of DBT
Time 2 - day of completion of second module of DBT
Time 3 - day of completion of third module of DBT
Secondary outcome [2] 351881 0
Self-injurious behaviours
This outcome is self-reported and defined as deliberate self-injury - some sites specify suicidal or non suicidal intent, others do not. Participants self-monitor the frequency of self-harm behaviours daily on a diary card, which they present to their individual therapist at the weekly therapy session. This is recorded differently depending upon the site. At TPCH, PAH, Logan and Caboolture, individual therapists enter the frequency of self-harm behaviours on an excel spreadsheet. At the RBWH, the individual therapists report the frequency at the weekly consultation group and it is tallied in the consult group minutes.
Timepoint [2] 351881 0
At assessment of suitability for DBT program
Time 1 - day of completion of first module of DBT
Time 2 - day of completion of second module of DBT
Time 3 - day of completion of third module of DBT
Secondary outcome [3] 351883 0
Suicidal behaviours
This outcome is self-reported. Participants self-monitor the frequency of self-harm behaviours daily on a diary card, which they present to their individual therapist at the weekly therapy session. This is recorded differently depending upon the site. At TPCH, PAH, Logan and Caboolture, individual therapists enter the frequency of self-harm behaviours on an excel spreadsheet. At the RBWH, the individual therapists report the frequency at the weekly consultation group and it is tallied in the consult group minutes.
Timepoint [3] 351883 0
At assessment of suitability for DBT program
Time 1 - day of completion of first module of DBT
Time 2 - day of completion of second module of DBT
Time 3 - day of completion of third module of DBT

Eligibility
Key inclusion criteria
Subjects are clients open to the Princess Alexandra Hospital, Logan Hospital, Royal Brisbane and Women's Hospital, Prince Charles Hospital and Caboolture Hospital, meeting DSM-5 criteria for Borderline Personality Disorder (at least 5 out of 9 criteria). Criterion 4 and/or 5 must be met.
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Intellectual functioning that would limit understanding elements of treatment (IQ<80)
Currently on an Involuntary Treatment Order
Acute psychosis
Behaviours that endanger the safety or wellbeing of other group members (eg aggression, violence)
Severe substance abuse
Disabling organic conditions that would interfere with engagement in and benefit from the program
Florid antisocial behaviour
Receiving psychotherapy from another source and unwilling to cease

Study design
Purpose of the study
Treatment
Allocation to intervention
Non-randomised trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
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
Primary outcomes of interest are DERS, WoCCL and IIP-32, all of which will be measured on a continuous scale. Other outcomes of interest are BSL-23 as an overall measure of BPD symptoms . Baseline patient characteristics will be summarised usinf means (SD), or medians (interquartile range) for continuous variables and frequencies and percentages for categorical variables. Linear regression models will be used to assess associations between patient characteristics and site and the mean values for each outcome at baseline. The effects of covariates of interest on changes in outcomes over time will be modelled using mixed effects linear regression models. These models take account of repeated measures on the same patient and allow estimation of the effects of each of the covariates of interest whilst controlling for potential confounders. They are also appropriate for use where some measures may be missing for some participants.

Each of the three arms are expected to have approximately 36 unique participants taking part in the research over a two-year period, which is a total of 108 unique participants. Expected attrition is 20%, leaving 86 overall participants. These numbers have demonstrated sufficient power calculations.

Recruitment
Recruitment status
Recruiting
Date of first participant enrolment
Anticipated
Actual
5/07/2018
Date of last participant enrolment
Anticipated
7/01/2021
Actual
Date of last data collection
Anticipated
1/07/2021
Actual
Sample size
Target
108
Accrual to date
66
Final
Recruitment in Australia
Recruitment state(s)
QLD
Recruitment hospital [1] 11842 0
Princess Alexandra Hospital - Woolloongabba
Recruitment hospital [2] 11843 0
Logan Hospital - Meadowbrook
Recruitment hospital [3] 11844 0
Royal Brisbane & Womens Hospital - Herston
Recruitment hospital [4] 11845 0
The Prince Charles Hospital - Chermside
Recruitment hospital [5] 11846 0
Caboolture Hospital - Caboolture
Recruitment postcode(s) [1] 23980 0
4102 - Woolloongabba
Recruitment postcode(s) [2] 23981 0
4131 - Meadowbrook
Recruitment postcode(s) [3] 23982 0
4029 - Herston
Recruitment postcode(s) [4] 23983 0
4032 - Chermside
Recruitment postcode(s) [5] 23984 0
4510 - Caboolture

Funding & Sponsors
Funding source category [1] 300481 0
Hospital
Name [1] 300481 0
Metro North Hospital and Health Service
Country [1] 300481 0
Australia
Funding source category [2] 300669 0
Hospital
Name [2] 300669 0
Metro South Hospital and Health Service
Country [2] 300669 0
Australia
Primary sponsor type
University
Name
University of Queensland
Address
St Lucia
QLD 4072
Country
Australia
Secondary sponsor category [1] 299952 0
University
Name [1] 299952 0
Charles Sturt University
Address [1] 299952 0
Bathurst
NSW 2650
Country [1] 299952 0
Australia

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 301282 0
The Prince Charles Hospital Human Research Ethics Committee
Ethics committee address [1] 301282 0
Ethics committee country [1] 301282 0
Australia
Date submitted for ethics approval [1] 301282 0
28/09/2017
Approval date [1] 301282 0
20/11/2017
Ethics approval number [1] 301282 0
HREC/17/QPCH/172

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

Contacts
Principal investigator
Name 86478 0
Dr Sarah Swannell
Address 86478 0
Dr Sarah Swannell
DBT Coordinator
The Prince Charles Hospital
Metro North Mental Health Service
10 Nellie St
Nundah QLD 4012
Country 86478 0
Australia
Phone 86478 0
+61 0731462567
Fax 86478 0
Email 86478 0
s.swannell@uq.edu.au
Contact person for public queries
Name 86479 0
Sarah Swannell
Address 86479 0
Dr Sarah Swannell
DBT Coordinator
The Prince Charles Hospital
Metro North Mental Health Service
10 Nellie St
Nundah QLD 4012
Country 86479 0
Australia
Phone 86479 0
+61 0731462567
Fax 86479 0
Email 86479 0
s.swannell@uq.edu.au
Contact person for scientific queries
Name 86480 0
Sarah Swannell
Address 86480 0
Dr Sarah Swannell
DBT Coordinator
The Prince Charles Hospital
Metro North Mental Health Service
10 Nellie St
Nundah QLD 4012
Country 86480 0
Australia
Phone 86480 0
+61 0731462567
Fax 86480 0
Email 86480 0
s.swannell@uq.edu.au

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
No/undecided IPD sharing reason/comment
No plan to share IPD.


What supporting documents are/will be available?

Doc. No.TypeCitationLinkEmailOther DetailsAttachment
4777Study protocol    375855-(Uploaded-13-09-2019-12-20-05)-Study-related document.pdf



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.