Trial Review

Please note the ANZCTR will be unattended from Friday 20 December 2024 for the holidays. The Registry will re-open on Tuesday 7 January 2025. Submissions and updates will not be processed during that time.

Registering a new trial?

To achieve prospective registration, we recommend submitting your trial for registration at the same time as ethics submission.

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been endorsed by the ANZCTR. Before participating in a study, talk to your health care provider and refer to this information for consumers
Trial registered on ANZCTR


Registration number
ACTRN12622000623796
Ethics application status
Approved
Date submitted
10/04/2022
Date registered
28/04/2022
Date last updated
28/04/2022
Date data sharing statement initially provided
28/04/2022
Type of registration
Retrospectively registered

Titles & IDs
Public title
A comparison of online and face-to-face Dialectical Behaviour Therapy: A parallel group randomized trial and pragmatic evaluation
Scientific title
A comparison of online and face-to-face Dialectical Behaviour Therapy: A parallel group randomized trial and pragmatic evaluation
Secondary ID [1] 306891 0
None
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Emotional dysregulation 325989 0
Borderline Personality Disorder 325990 0
Condition category
Condition code
Mental Health 323304 323304 0 0
Other mental health disorders

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
This project will compare the outcomes of face-to-face provision of Dialectical Behaviour Therapy (DBT) with online delivery in a naturalistic setting.
The standard DBT programme consists of individual therapy, skills training (undertaken in groups), the opportunity for out-of-session skills coaching if required and therapists who are supported by attendance at a weekly consultation group.
Multiple mental health practitioners employed by The Australian DBT Institute will deliver the intervention. Practitioners qualifications comprise Psychologist's, Mental Health Social Workers and Mental Health Nurses. The DBT Institute utilises a DBT- trauma informed (DBT-TI) adaptation to the standard DBT program developed by Marsha Linehan (1993). DBT-TI was developed by the DBT Institutes founder Dr Peter King to address the gap in trauma informed practice in DBT. The Institute’s comprehensive DBT-TI program comprises all modes of treatment identified in standard DBT (Linehan, 1993): Individual Therapy (including commitment), DBT Skills Training, Phone Coaching and Consultation team with a trauma informed lens. Individual therapy is typically 60-90 minutes duration and held weekly. Group skills training is typically 3 hours duration, face-to-face and 90 minutes undertaken online.

In the trauma informed DBT approach, Individual Therapy consists of a pre-treatment stage, in addition to psychosocial assessment, orientation and commitment, in conjunction with specific assessment of trauma conducted by an intake clinician. Following this, there is a phase of stabilization conducted by an individual therapist, trained in the trauma informed DBT approach, in which patients are assisted to become aware of existing resources and to promote a sense of self-agency in participants that also includes feeling safe and contained. Furthermore, psychoeducation, neuroeducation and a learning style assessment are carried out so that individuals gain awareness and understanding of their presenting symptoms, triggers, somatic markers as well as ways of maintaining themselves in the regulated zone or ‘window of tolerance’ (Baldini et al., 2014) and preventing autonomic dysregulation with strategies such as ‘applying the brakes’ (Rothschild, 2017, p. 79) in distressing situations. Part of the stabilization phase is weekly engagement in DBT skills training in a group setting where participants learn how to integrate the new skills into their environments.
Attendance is recorded for both group engagement and individual therapy.
The 27 week group therapy program consists of three modules each of 9 week duration.
Outcome measures are administered at the beginning of each 9 week module and consist of
• The Depression Anxiety & Stress Scale 21 (DASS-21) (Lovibond & Lovibond, 1995)
• Difficulties in Emotion Regulation Scale (DERS-16) (Gratz & Roemer, 2004)
• The Borderline Symptom List (BSL-23) and supplementary behavioural questions (Kleindienst et al., 2020). All standard measures generally used in DBT programs.
DBT is focused on a treatment hierarchy commencing with life threatening behaviours, therapy interfering behaviours and those which interfere with quality of life (Linehan, 1993; Linehan, 2015). The incidence of negotiated treatment targets (thoughts, feelings or behaviours) are recorded on bespoke diary cards unique to each individual. It is therefore proposed that individuals provide a brief statement about what their aspirations are at the beginning of treatment and a summary of what they have addressed and what is important to them at commencement and at the end of each skills module.

Qualitative Interviews

The purpose of these qualitative interviews are to provide a case series to illustrate in a more personal way how people progress in DBT, what outcomes are most meaningful and what is most helpful in achieving those outcomes.

The most closely matched client who consents to being interviewed (according to baseline measures) in the face-to-face therapy will be matched with an on-line allocated client (most closely matched) for each therapist.

These clients will be interviewed near commencement, approximately half-way through the programme, on completion and at 36 weeks (3 months follow-up). With their permission they will be interviewed with their therapist.

A minimum of 6 clients will be interviewed. Whilst the focus will largely be on the client’s experience interviewing the therapist and client together acknowledges the importance of the therapeutic alliance between personal therapist and client (Bedics et al., 2015) and enables the therapist to work through any issues which might arise for the client in that conversation. Discussions about treatment goals and progress with DBT therapists is a usual practice and open discussion about the alliance which includes shared goals and understanding is considered so important that tools have been developed to facilitate such conversations at every session and across psychotherapeutic approaches (Duncan et al., 2003). Actual skill use has been found to be a predictor of symptom improvement and retention in therapy (Barnicot et al., 2016). Gauging which skills individuals have learned, used and found useful will provide a potentially rich insight into the process of therapy.

The interviewer will be an experienced DBT therapist (with no association with the Australian DBT Institute) and the and will address in a semi-structured way the following questions:
1. What the expectation and focus of treatment has been;
2. What elements of the process have been considered most helpful or challenging;
3. What have been the most personally significant outcomes for individuals;
4. What skills have been acquired and been found to be useful.

The qualitative data will be analyzed using inductive methods informed by grounded theory (Corbin & Strauss, 2014). Members of the team have utilized a similar method to describe the process of change in a naturalistic DBT programme (Lakeman & Emeleus, 2020).

Intervention code [1] 323345 0
Treatment: Other
Comparator / control treatment
Both face-to-face and online DBT are considered accepted modes of delivery. This trial compares those allocated to either face-to-face or online individual therapy and skills group training.
The comparator condition will consist of all aspects of the above described DBT-TI intervention program but will be delivered entirely via online video-conferencing platform Zoom. The only thing that will vary from usual care and treatment is the random allocation to either face-to-face or online provision only for one complete cycle of DBT.
Control group
Active

Outcomes
Primary outcome [1] 331038 0
The Depression Anxiety & Stress Scale 21 (DASS-21) (Lovibond & Lovibond, 1995). Change in symptoms as measured by the DASS-21.
Timepoint [1] 331038 0
Week 1 of module 1 of group therapy skills program (Baseline),
Week 1 of module 2 of group therapy skills program
Week 1 of module 3 of group therapy skills program
Three months post completion of the group therapy skills program (primary timepoint)
Primary outcome [2] 331039 0
The Borderline Symptom List (BSL-23) and supplementary behavioural questions (Kleindienst et al., 2020). Change in symptoms as measured by the BSL-23.
Timepoint [2] 331039 0
Week 1 of module 1 of group therapy skills program (Baseline),
Week 1 of module 2 of group therapy skills program
Week 1 of module 3 of group therapy skills program
Three months post completion of the group therapy skills program (primary timepoint)
Primary outcome [3] 331094 0
Difficulties in Emotion Regulation Scale (DERS-16) (Gratz & Roemer, 2004). Change in symptoms as measured by the DERS-16.
Timepoint [3] 331094 0
Week 1 of module 1 of group therapy skills program (Baseline),
Week 1 of module 2 of group therapy skills program
Week 1 of module 3 of group therapy skills program
Three months post completion of the group therapy skills program (primary timepoint)
Secondary outcome [1] 408567 0
Semi-Structured interviews will be conducted with clients (and with client permission) together with their therapists. Qualitative data regarding progress, expectations, preferences and the quality of the experience will be collected from these interviews and analysed together as a composite outcome.
Timepoint [1] 408567 0
On commencement of Week 1 of module 1 of group therapy skills program (Baseline),
Week 4 of Module 2 of group therapy skills program
Week 9 of module 3 of group therapy skills program.
Three months post completion of the programme.
Secondary outcome [2] 408731 0
The World Health Organization Brief Quality of Life Assessment (WHOQUOL-BREF) (The Whoqol Group., 1998). Change in quality of life as measured by the WHOQUOL-BREF
Timepoint [2] 408731 0
Week 1 of module 1 of group therapy skills program (Baseline),
Week 9 of module 3 of group therapy skills program (middle)
Three months post completion of the programme.

Eligibility
Key inclusion criteria
Have been assessed as competent and eligible to participate in DBT and accepted into the Australian DBT Institute programme.; Able to attend either face-to-face (at Melbourne or Gold Coast Clinics) or attend online if allocated to either mode of delivery.
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Not accepted into Australian DBT Institute programme; No access to the internet or inability to attend face-to-face; Significant cognitive impairment or incapacity to engage fully in the DBT programme.

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 allocated to a therapist as per usual protocols. Each therapist will have a finite capacity to see referred participants. Each therapist will have an equal number of allocations for online or face-to-face therapy. These allocations will be placed in an individual envelope and these envelopes shuffled. The research officer will open a randomly selected envelope (assigned to each therapist) to reveal the person’s allocated mode of delivery after they have consented to participate.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Sequence generation of client and therapist dyads into each condition of either face to face or online delivery of the intervention will consist of simple randomisation using computerised 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
Previous evidence suggests that it is reasonable to expect changes in the main variables (pre to post) to have a Cohen’s d of not less than .5 (moderate sized effects). This results in power for the tests of repeated measures of approximately 75%. While this is slightly below optimal, clinical members of the team are confident that outcomes should be of clinical significance, which would result in much greater power. Any differences between the effectiveness of treatments will be assessed as the interaction component of a mixed-model ANOVA, which is the most powerful method for detecting such differences. It should be noted, however, that the team’s expectation is that the online training will be at least as effective as the traditional approach, if not superior.

Recruitment
Recruitment status
Recruiting
Date of first participant enrolment
Anticipated
Actual
22/04/2022
Date of last participant enrolment
Anticipated
29/04/2022
Actual
Date of last data collection
Anticipated
6/03/2023
Actual
Sample size
Target
60
Accrual to date
6
Final
Recruitment in Australia
Recruitment state(s)
NSW,QLD

Funding & Sponsors
Funding source category [1] 311205 0
University
Name [1] 311205 0
Faculty of Health, Southern Cross University
Country [1] 311205 0
Australia
Funding source category [2] 311206 0
Commercial sector/Industry
Name [2] 311206 0
Australian DBT Institute
Country [2] 311206 0
Australia
Primary sponsor type
Individual
Name
Richard Lakeman
Address
Gold Coast Campus, B7.41
Southern Cross Drive, Bilinga QLD 4225
Country
Australia
Secondary sponsor category [1] 312575 0
Commercial sector/Industry
Name [1] 312575 0
The Australian DBT Institute
Address [1] 312575 0
Level 1, 115 Scarborough St Southport QLD 4215
Country [1] 312575 0
Australia

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 310735 0
Southern Cross University Human Research Ethics Committee
Ethics committee address [1] 310735 0
Ethics committee country [1] 310735 0
Australia
Date submitted for ethics approval [1] 310735 0
Approval date [1] 310735 0
08/04/2022
Ethics approval number [1] 310735 0
2022/033

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

Contacts
Principal investigator
Name 118682 0
A/Prof Richard Lakeman
Address 118682 0
Southern Cross University
Faculty of Health
Gold Coast Campus, B7.41
Southern Cross Drive, Bilinga QLD 4225
Country 118682 0
Australia
Phone 118682 0
+61 755893354
Fax 118682 0
Email 118682 0
richard.lakeman@scu.edu.au
Contact person for public queries
Name 118683 0
Richard Lakeman
Address 118683 0
Southern Cross University
Faculty of Health
Gold Coast Campus, B7.41
Southern Cross Drive, Bilinga QLD 4225
Country 118683 0
Australia
Phone 118683 0
+61 755893354
Fax 118683 0
Email 118683 0
richard.lakeman@scu.edu.au
Contact person for scientific queries
Name 118684 0
Richard Lakeman
Address 118684 0
Southern Cross University
Faculty of Health
Gold Coast Campus, B7.41
Southern Cross Drive, Bilinga QLD 4225
Country 118684 0
Australia
Phone 118684 0
+61 755893354
Fax 118684 0
Email 118684 0
richard.lakeman@scu.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
Only aggregated de-identified data will be shared.


What supporting documents are/will be available?




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.