Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12622000113752
Ethics application status
Approved
Date submitted
16/12/2021
Date registered
24/01/2022
Date last updated
31/05/2024
Date data sharing statement initially provided
24/01/2022
Type of registration
Prospectively registered

Titles & IDs
Public title
Internet Delivered Skills Training for Chronic Pain
Scientific title
Efficacy of the iDBT-Pain skills training intervention for emotion dysregulation and pain intensity in people with chronic pain: A Randomised Controlled Trial
Secondary ID [1] 305921 0
Nil Known
Universal Trial Number (UTN)
Trial acronym
Linked study record
ACTRN12620000604909 is the clinical trial registration for our pilot study which investigated the iDBT-Pain intervention. This pilot study demonstrated feasibility, acceptability and preliminary efficacy for the iDBT-Pain intervention to reduce pain intensity and emotion dysregulation. The current study is a randomised controlled trial which seeks to further investigate the iDBT-Pain intervention in a larger sample to determine effectiveness.

Health condition
Health condition(s) or problem(s) studied:
Chronic Pain 324510 0
Condition category
Condition code
Anaesthesiology 321988 321988 0 0
Pain management

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Description of intervention(s) / exposure: This study is a pilot randomised controlled trial (RCT) to investigate the efficacy of an internet-delivered skills training for people with chronic pain. There are two arms to this trial (1) Treatment, and (2) Treatment-as-usual (described under comparator/control).

Arm 1 (Treatment group)
Participants in the treatment arm will receive the iDBT-Pain intervention (internet-delivered dialectical behavioural therapy skills training). This intervention is designed to teach skills from dialectical behavioural therapy, in mindfulness, emotion regulation, and distress tolerance alongside psychoeducation about chronic pain.
The iDBT-Pain intervention involves a total of eight 60-90-minute-long sessions (including an introductory and concluding session), delivered over the internet using Zoom. The content in the sessions will include presentations covering the theory behind the association between chronic pain and emotions, demonstrations on how to practice DBT skills such as mindfulness to be present without judgement and will facilitate group discussions around specific skills-based activities. The sessions will be delivered to participants as part of a group of around 8 to 12 participants every 7 days across eight weeks.

For the duration of the eight weeks, and for one week after the concluding session, participants will have continued access to a web app (iDBT-Pain web app) which participants will access on their own smart device (e.g., iPhone or computer) with their own secure password and username. The iDBT-Pain app includes videos and tasks to encourage skills practice in mindfulness, emotion regulation and distress tolerance between the Zoom sessions. Participants will be asked to practice skills in the app daily but will not be given a specific duration of time they need to practice. This format for the skills training mirrors that used in our successful pilot study (ACTRN: 12620000604909) where no difficulties in adherence were observed. To ensure fidelity and consistency, the iDBT-Pain skills training will follow the study protocol developed and trialled by Norman-Nott et al (2021).

The iDBT-Pain intervention will be administered by a certified DBT skills trainer. It is not anticipated that participants will experience substantial distress associated with this intervention because it is a skills training designed to teach new capabilities in pain and emotion management and is not a psychotherapy. Nevertheless, the principal investigator is an AHPRA registered psychologist and can be contacted if any unforeseen distress arises because of the skills training. If for any reason participants do experience increased distress, they will be able to discontinue the program, and be referred to alternative sources of support.
Intervention code [1] 322316 0
Behaviour
Intervention code [2] 322595 0
Treatment: Other
Comparator / control treatment
Arm 2 (Treatment-as-usual)
Participants in the treatment-as-usual group will receive no intervention as part of the trial. Instead, participants in this group may receive treatment options as offered by the healthcare professionals they would normally consult with in the community.
Control group
Active

Outcomes
Primary outcome [1] 329747 0
The Difficulties in Emotional Regulation Scale (DERS) will serve as the primary outcome measure. The 18-item version will be used to assess participant’s levels of emotional dysregulation. Items are rated on a scale of 1 (“almost never”) to 5 (“almost always”) with higher scores indicating increased difficulty in emotion regulation.
Timepoint [1] 329747 0
The DERS will be measured at baseline, post intervention (primary endpoint), and at 3-month follow-up.
Secondary outcome [1] 403653 0
Numeric Rating Scale (NRS)
The NRS is a validated and reliable numerical scale ranging from 0 to 10 to assess pain intensity with 0 representing one extreme (no pain) and 10 representing the other extreme (pain as bad as it could be).
Timepoint [1] 403653 0
Administered at baseline, post intervention and at 3-month follow-up.
Secondary outcome [2] 403783 0
PROMIS Pain interference instrument (PROMIS-PI)
The PROMIS-PI is a validated and reliable 8-item measure to assess pain interference.
Timepoint [2] 403783 0
Administered at baseline, post intervention and at 3-month follow-up.
Secondary outcome [3] 403784 0
PTSD Checklist – Civilian version (PCL-C)
The PCL-C is a validated and reliable 17-item self-report measure to assess trauma.
Timepoint [3] 403784 0
Administered at baseline, post intervention and at 3-month follow-up.
Secondary outcome [4] 403785 0
Beck Depression Inventory (BDI)
The BDI is a validated and reliable 4-item self-report measure to assess symptoms of depression.
Timepoint [4] 403785 0
Administered at baseline, post intervention and at 3-month follow-up.
Secondary outcome [5] 403786 0
State-Trait Anxiety Inventory (STAI)
The state anxiety subscale from the STAI is a 20-item validated and reliable self-report measure to assess symptoms of anxiety.
Timepoint [5] 403786 0
Administered at baseline, post intervention and at 3-month follow-up.
Secondary outcome [6] 403787 0
NIH Toolbox Perceived Stress Scale (NIH-PSS)
The NIH-PSS is a validated and reliable 10-item self-report measure to assess perceived levels of stress.
Timepoint [6] 403787 0
Administered at baseline, post intervention, and at 3-month follow-up.
Secondary outcome [7] 403789 0
Medical Outcomes Study – Sleep Scale (MOS-SS)
The MOS-SS is the Sleep problem index II of the MOS and is a validated and reliable 9-item self-report index used to assess sleep quality.
Timepoint [7] 403789 0
Administered at baseline, post intervention and at 3-month follow-up.
Secondary outcome [8] 403790 0
Temperament and Character Inventory Harm Avoidance Scale (TCI-HA)
The TCI-HA is a validated and reliable 35-item self-report scale to measure the character trait of harm avoidance.
Timepoint [8] 403790 0
Administered at baseline, post intervention and at 3-month follow-up.
Secondary outcome [9] 403791 0
COMPAS-W Scale of Wellbeing (COMPAS-W)
The COMPAS-W is a validated and reliable 26-item self-report scale to measure the overall wellbeing.
Timepoint [9] 403791 0
Administered at baseline, post intervention and at 3-month follow-up.
Secondary outcome [10] 403792 0
Dialectical Behaviour Therapy Ways of Coping Checklist (DBT-WCCL)
The DBT-WCCL is a validated and reliable 59-item self-report measure to assess emotional effectiveness and coping behaviours.
Timepoint [10] 403792 0
Administered at baseline, post intervention and at 3-month follow-up.
Secondary outcome [11] 403793 0
Satisfaction with Life Scale (SWLS)
The SWLS is a validated and reliable 5-item measure to assess the overall life satisfaction.
Timepoint [11] 403793 0
Administered at baseline, post intervention and at 3-month follow-up.
Secondary outcome [12] 403794 0
Health-Related Quality of Life Scale (EQ-5D-5L)
The EQ-5D-5L is a validated and reliable 5-item measure plus vertical visual analogue scale to measure aspects of health-related quality of life to conduct a cost-effectiveness analysis.
Timepoint [12] 403794 0
Administered at baseline, post intervention and at 3-month follow-up.
Secondary outcome [13] 403795 0
Healthcare Utilisation questionnaire (HUQ)
The HUQ is a 9-item questionnaire to gather details about participants usual use of healthcare services.
Timepoint [13] 403795 0
Administered at baseline, post intervention and at 3-month follow-up.
Secondary outcome [14] 403796 0
Chronic Pain Medication and Health Intervention Questionnaire (CPM-HIQ)
The CPM-HIQ is a to measure current and prior medication and health interventions.
Timepoint [14] 403796 0
Administered at baseline, post intervention and at 3-month follow-up.
Secondary outcome [15] 403797 0
Usefulness, Satisfaction and Ease of Use Scale (USE)
The USE is a validated and reliable measure to assess the satisfaction and useability of the intervention.
Timepoint [15] 403797 0
Administered at post-intervention and at 3-month follow-up.
Secondary outcome [16] 403798 0
Patient Global Impression of Change Scale (PGIC)
The PGIC is a validated and reliable measure to assess participants impression of change following the intervention.
Timepoint [16] 403798 0
Administered at post-intervention and at 3-month follow-up.

Eligibility
Key inclusion criteria
a) Adults aged 18 years or over.
b) Have access to the internet to participant in the Zoom sessions and have access to a smart phone/ tablet device capable of running the iDBT-Pain web app.
c) Commits to fully participate in the skills training e.g., attend all the iDBT-Pain sessions held weekly on Friday lunchtimes (12pm to 3pm AEST) and train skills daily using the iDBT-Pain app.
d) Fluent in speaking and reading English.
e) Average pain rating equal to or more than 3 for the past seven days (Numeric Rating Scale; NRS).
Minimum age
18 Years
Maximum age
80 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
a) Diagnosed psychiatric conditions or mental health disorder (e.g., schizophrenia, bipolar disorder, major depression etc)
b) Diagnosis for dementia or Alzheimer’s disease
c) Located outside of Australia

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 involves contacting the holder of the allocation schedule who is not involved in the trial treatment or randomisation
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Participants will be randomly allocated to groups (treatment or treatment-as-usual) in blocks of 6. A total of 100 participants will be randomised. A randomisation schedule will be created in Excel by the statistician who is not involved in the treatment.
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?



The people analysing the results/data
Intervention assignment
Parallel
Other design features
Phase
Not Applicable
Type of endpoint/s
Efficacy
Statistical methods / analysis
Power Analysis
The nominated sample is based on a sampled size calculation using SAS 9.4. To calculate sample size for the current trial the effect size from our pilot data from the secondary outcome (pain intensity, effect size = .82) has been used as it had a lower effect size than the primary outcome (i.e., emotional dysregulation, effect size = .88). To detect a mean difference of effect size 0.7 between treatment groups in the secondary outcome (i.e., pain intensity), a total of 100 people (50 in each group) will be required. This assumes 80% power, alpha of 0.05 and a within-subjects correlation of 0.2. To account for an expected 15-20% attrition, the total sample size is 100.

Statistical Analysis
For all outcomes that are normally-distributed and measured over time, a linear mixed model with random effect of individual will be specified. Fixed effects of time, treatment group and the interaction will be included. Treatment differences at 9 weeks and at 21 weeks and change from baseline to 9 and 21 weeks within each group will be estimated. If the distributional assumption of normality is not tenable, an appropriate transformation of the outcome will be conducted. Alternatively, a generalized linear mixed model with appropriate distribution and link will be used.
The data will be analysed on an intention-to-treat basis. Unadjusted and adjusted analyses will be conducted. Adjusted analyses will include age at baseline and gender. P-values <0.05 will be considered significant.

Recruitment
Recruitment status
Recruiting
Date of first participant enrolment
Anticipated
14/11/2022
Actual
2/03/2023
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
100
Accrual to date
89
Final
Recruitment in Australia
Recruitment state(s)
ACT,NSW,NT,QLD,SA,TAS,WA,VIC

Funding & Sponsors
Funding source category [1] 310261 0
Charities/Societies/Foundations
Name [1] 310261 0
Rebecca L Cooper Medical Research Foundation
Country [1] 310261 0
Australia
Funding source category [2] 310546 0
Government body
Name [2] 310546 0
Australian Government Research Training Program Scholarship
Country [2] 310546 0
Australia
Primary sponsor type
University
Name
University of New South Wales
Address
NeuroRecovery Research Hub, Level 1, BioLink Building, University of New South Wales, Sydney NSW 2052
Country
Australia
Secondary sponsor category [1] 311361 0
None
Name [1] 311361 0
Address [1] 311361 0
Country [1] 311361 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 309933 0
UNSW Human Research Ethics Committee
Ethics committee address [1] 309933 0
The University of New South Wales
Sydney NSW 2052 Australia
Ethics committee country [1] 309933 0
Australia
Date submitted for ethics approval [1] 309933 0
21/02/2022
Approval date [1] 309933 0
24/03/2022
Ethics approval number [1] 309933 0
HC220078

Summary
Brief summary
In a recent pilot study (ACTRN: 12620000604909) evidence was promising for the feasibility, acceptability and efficacy of an online skills training for people in chronic pain (internet-delivered dialectical behavioural therapy skills training; iDBT-Pain). We now aim to further investigate the effectiveness of iDBT-Pain in a Randomised Control Trial (RCT). iDBT-Pain is an online training to teach skills for more effective emotion regulation. iDBT-Pain utilises evidence-based protocols for DBT skills training and will be administered according to the DBT Skills Training manual (Linehan, 2015). The intervention includes eight group-based sessions delivered to participants via Zoom, and access to a web app.

It is hypothesised that the iDBT-Pain intervention will significantly reduce emotion dysregulation in people with chronic pain. It is further hypothesised that there may be changes in secondary outcomes related to chronic pain, including, pain intensity, pain interference, trauma, depression, anxiety, stress, sleep quality, harm avoidance, coping behaviours, and satisfaction with life.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 115890 0
A/Prof Sylvia Gustin
Address 115890 0
BioLink Building
The University of New South Wales
Sydney NSW 2052 Australia
Country 115890 0
Australia
Phone 115890 0
+61 413278336
Fax 115890 0
Email 115890 0
s.gustin@unsw.edu.au
Contact person for public queries
Name 115891 0
Ms Nell Norman-Nott
Address 115891 0
BioLink Building
The University of New South Wales
Sydney NSW 2052 Australia
Country 115891 0
Australia
Phone 115891 0
+61 2 9399 1894
Fax 115891 0
Email 115891 0
n.normannott@unsw.edu.au
Contact person for scientific queries
Name 115892 0
Ms Nell Norman-Nott
Address 115892 0
BioLink Building
The University of New South Wales
Sydney NSW 2052 Australia
Country 115892 0
Australia
Phone 115892 0
+61 2 9399 1894
Fax 115892 0
Email 115892 0
n.normannott@unsw.edu.au

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
Yes
What data in particular will be shared?
De-identified individual participant data of published results will be made available upon reasonable request.
When will data be available (start and end dates)?
Data will be made available after the publication of study reports. There is no end date for the availability of study data.
Available to whom?
De-identified individual participant data will be made to interested researchers only upon reasonable request and once the proposed research project has received separate ethics approval from a Human Research Ethics Committee
Available for what types of analyses?
Any
How or where can data be obtained?
Request to the data custodian, the Principal Investigator (s.gustin@unsw.edu.au)


What supporting documents are/will be available?

Doc. No.TypeCitationLinkEmailOther DetailsAttachment
14325Study protocol  n.normannott@unsw.edu.au
14326Ethical approval  n.normannott@unsw.edu.au
14339Informed consent form  n.normannott@unsw.edu.au



Results publications and other study-related documents

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No documents have been uploaded by study researchers.

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