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Trial registered on ANZCTR


Registration number
ACTRN12620000604909
Ethics application status
Approved
Date submitted
20/04/2020
Date registered
25/05/2020
Date last updated
25/05/2020
Date data sharing statement initially provided
25/05/2020
Type of registration
Prospectively registered

Titles & IDs
Public title
Internet-delivered dialectical behaviour therapy (iDBT) skills training to reduce difficulties in emotional dysregulation and pain in people with chronic pain
Scientific title
Evaluation of the effectiveness of iDBT Pain skills training to reduce difficulties in emotional regulation and pain in people with chronic pain: protocol for a single-case experimental design with multiple baselines
Secondary ID [1] 301060 0
Nil known
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Chronic Pain 317117 0
Condition category
Condition code
Anaesthesiology 315278 315278 0 0
Pain management
Neurological 315429 315429 0 0
Other neurological disorders

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
This study will use a single-case experimental design (SCED) with multiple baselines across participants. The SCED method is based on assessing the dependent variables (emotional regulation and pain intensity) repeatedly for each of the participants across several phases. The design of this study will be AB + follow-up, where A refers to the baseline phase and B is the intervention phase. Three participants will be randomly assigned to different baseline durations. The baseline for the first participant will be 5 days, the second participant will have a 9-day baseline, and the third participant will have a 12-day baseline. All participants will start the baseline phase on the same day. During the baseline phase, participants will complete the self-report questionnaires (i.e., Visual Analogue Scale (VAS) and Difficulties in Emotion Regulation Scale (DERS)) on every day of the baseline phase. Each baseline phase will be followed by 6 sessions of internet delivered Dialectic Behaviour Therapy (iDBT) skills training intervention plus unlimited use of an iDBT skills training web application over a 4-week period. The follow up phase will begin the day after the intervention and will last for one week, whereby each participant will report on the primary and secondary dependent variables (emotional regulation and pain intensity respectively) in order to monitor possible changes in pain intensity and pain interference after completion of the intervention.
Intervention: Six iDBT skills training intervention sessions will be delivered individually to each participant over the video conferencing platform Zoom at agreed times during the 4-week period. The iDBT skills training intervention is based on the iDBT protocol developed by Wilks et al. (2017) and has been modified for the chronic pain population (iDBT-Pain skills training intervention including two “Mindfulness” skill training intervention sessions, three “Emotional Regulation” skill training intervention sessions and one “Distress Tolerance” skill training intervention session). Each session will be administered by a researcher (in this trial an AHPRA registered psychologist) and is 60-90 minutes in duration. In-between the iDBT-Pain skills training intervention sessions the participants will be asked to train their newly learned DBT skills using the iDBT skills training web application developed by Wilks and colleagues (2018), which has been modified for the chronic pain population (iDBT-Pain skills training web application). No instruction will be given about the duration of usage of the iDBT-Pain skills training web application. The participants will be contacted everyday to ensure they are using the iDBT-Pain skills training we application.
Intervention code [1] 317363 0
Treatment: Other
Comparator / control treatment
No control group
Control group
Uncontrolled

Outcomes
Primary outcome [1] 323521 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 regulation. 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] 323521 0
The DERS will be measured on every day of the baseline (i.e., 5, 9 or 12 days) and follow-up (7 days) as well as 6 times during the iDBT intervention phase (i.e., following each of the 6 iDBT intervention sessions).
Secondary outcome [1] 382149 0
The Visual Analogue Scale (VAS) will serve as the secondary outcome measure of chronic pain. The VAS assesses pain intensity on a 0-10 scale (0 = “no pain” and 10 = “maximum pain imaginable”).
Timepoint [1] 382149 0
The study participants will be asked to rate the average intensity of pain during three specific epochs each day, using a VAS. At 12 noon, they will be asked to rate the average intensity of the pain they experienced from the time they woke up that day until noon. At 6 pm they will be asked to rate their average pain between noon and 6 pm. Finally, they will be asked to rate the average of the pain intensity they experienced between 6 pm and the time they went to bed at the time they go to bed. The mathematical average of the three ratings will then be computed to represent that participant’s average daily pain intensity. If any ratings are missing, the score will be the average of the ratings obtained. This daily paper-and-pencil pain diary will be completed by the participants every day during all phases: baseline (i.e., 5, 9 or 12 days), intervention (4 weeks) and follow-up ( 7 days) phases.
Secondary outcome [2] 382561 0
Generalisation measures will be collected to evaluate whether the effect of the treatment extends beyond improvements in the primary and secondary outcomes. The following measure will be included:

The COMPAS-W Scale of Wellbeing (COMPAS -W; (Gatt et al., 2014) is a 26-item self-report measures to assess psychological wellbeing. There are six subscales for different aspects of wellbeing: composure, own-worth, mastery, positivity, achievement, and satisfaction. A total score will be summed across all subscales with higher scores meaning greater wellbeing.
Timepoint [2] 382561 0
The generalisation measure will be administered at two time-points: (1) prior to the baseline phase, and (2) following completion of the follow-up phase.
Secondary outcome [3] 382929 0
Generalisation measures will be collected to evaluate whether the effect of the treatment extends beyond improvements in the primary and secondary outcomes. The following measure will be included:

The State Anxiety Inventory (SAI) (Spielberger et al., 1970) is 20-item self-report measure to assess state anxiety. A total score will be summed with higher scores indicating greater anxiety.
Timepoint [3] 382929 0
The generalisation measure will be administered at two time-points: (1) prior to the baseline phase, and (2) following completion of the follow-up phase.
Secondary outcome [4] 382930 0
Generalisation measures will be collected to evaluate whether the effect of the treatment extends beyond improvements in the primary and secondary outcomes. The following measure will be included:

The Beck Depression Inventory (BDI) (Beck et al., 1961) is a 21-item self-report measure to assess the severity of depressive symptoms. A total score will be summed with higher score indicating greater depressive symptoms.
Timepoint [4] 382930 0
The generalisation measure will be administered at two time-points: (1) prior to the baseline phase, and (2) following completion of the follow-up phase.
Secondary outcome [5] 382931 0
Generalisation measures will be collected to evaluate whether the effect of the treatment extends beyond improvements in the primary and secondary outcomes. The following measure will be included:

The Medical Outcomes Study Sleep Scale (MOS-SS) (Hays et al., 2005) is a 12-item self-report measure to assess key constructs of sleep quality and quantity including sleep initiation, maintenance, respiratory problems, quantity, perceived adequacy, and somnolence. Scores will be summed for each subscale with higher scores reflecting more sleep quality and quantity.
Timepoint [5] 382931 0
The generalisation measure will be administered at two time-points: (1) prior to the baseline phase, and (2) following completion of the follow-up phase.
Secondary outcome [6] 382932 0
Generalisation measures will be collected to evaluate whether the effect of the treatment extends beyond improvements in the primary and secondary outcomes. The following measure will be included:

The Temperament and Character Inventory Harm Avoidance Scale (TCI-HA) (Cloninger et al., 1993) is a 35-item self-report measure whereby statements are responded to as either True or False, to give a single score for the temperament of harm avoidance. This scale is one of seven scales that make up the complete TCI to measure four trait dimensions of temperament and three dimensions of character. Scores will be summed with higher scores meaning higher harm avoidance.
Timepoint [6] 382932 0
The generalisation measure will be administered at two time-points: (1) prior to the baseline phase, and (2) following completion of the follow-up phase.
Secondary outcome [7] 382933 0
Generalisation measures will be collected to evaluate whether the effect of the treatment extends beyond improvements in the primary and secondary outcomes. The following measure will be included:

Dialectic Behaviour Therapy Ways of Coping Checklist (DBT-WCCL) (Neacsiu et al., 2010) is a 59-item self-report measure to assess the types of coping behaviour that are employed. Each of the subscales for this measure (skills use scale, general dysfunctional coping and blaming others) will be summed to an individual average score. Higher scores on the general dysfunction and blaming others scales indicate lower ability to cope and higher scores on the skills use scale indicate greater usage of DBT skills for coping.
Timepoint [7] 382933 0
The generalisation measure will be administered at two time-points: (1) prior to the baseline phase, and (2) following completion of the follow-up phase.

Eligibility
Key inclusion criteria
Three individuals with chronic pain will be recruited for this study. Participants need to meet the following inclusion criteria: (1) aged 18-80 years, (2) chronic pain for more than 6 months, and (3) demonstrating an ability to use the Visual Analogue Scale (VAS).
Minimum age
18 Years
Maximum age
80 Years
Gender
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Regarding the neuroimaging component of the study, individuals who have metal objects inside their body (e.g., stents, metal clips, implants and shrapnel) may be excluded.

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
Who is / are masked / blinded?



Intervention assignment
Other design features
Phase
Not Applicable
Type of endpoint(s)
Efficacy
Statistical methods / analysis
Primary and secondary outcomes will be analysed separately based on the SCED analysis. The SCED analysis mainly relies on visual inspection, however, the outcome measures from this study will be inspected and analysed using both visual analysis and supplementary statistical analysis. In visual analysis, the baseline phase establishes a benchmark against the intervention phase to investigate any natural change in the outcome of interest. A structured analysis will be used to investigate whether the treatment-induced changes in the primary and secondary outcomes are reliable and consistent across participants.

Recruitment
Recruitment status
Not yet recruiting
Date of first participant enrolment
Anticipated
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
NSW

Funding & Sponsors
Funding source category [1] 305502 0
Charities/Societies/Foundations
Name [1] 305502 0
Rebecca L. Cooper Medical Research Foundation
Address [1] 305502 0
26/100 New South Head Rd, Sydney NSW 2027
Country [1] 305502 0
Australia
Primary sponsor type
Charities/Societies/Foundations
Name
Neuroscience Research Australia
Address
139 Barker St, Randwick NSW 2031
Country
Australia
Secondary sponsor category [1] 305900 0
None
Name [1] 305900 0
Address [1] 305900 0
Country [1] 305900 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 305814 0
UNSW Human Research Ethics Committee B
Ethics committee address [1] 305814 0
UNSW Research Ethics & Compliance Support
The University of New South Wales
Sydney NSW 2052 Australia
Ethics committee country [1] 305814 0
Australia
Date submitted for ethics approval [1] 305814 0
18/03/2020
Approval date [1] 305814 0
05/05/2020
Ethics approval number [1] 305814 0
HC200199

Summary
Brief summary
Difficulties in emotional regulation is one important factor in the development and maintenance of chronic pain. Some evidence already supports the potential for internet-delivered Dialectic Behaviour Therapy (iDBT) to reduce difficulties in emotional regulation and pain intensity. However, further studies are needed to provide bolster evidence regarding the effectiveness of iDBT in the chronic pain context.

A single-case experimental design (SCED) with multiple baselines will be used to examine the effectiveness of iDBT-Pain skills training intervention to reduce difficulties in emotional regulation and pain intensity in people with chronic pain. Three participants with chronic pain will be recruited. Each participant will be randomised to a different baseline phase (i.e., 5, 9 or 12 days), which will then be followed by 6 sessions of 60-90min iDBT skills training intervention over a 4-week period including unlimited usage of the iDBT-Pain skills training web application. The Difficulties in Emotional Regulation Scale (DERS) will serve as the primary outcome measure. The visual analogue scale assessing average pain intensity will serve as the secondary outcome measure. Generalisation measures will assess sleep quality, coping, temperament and anxiety and depressive symptoms as well as medial prefrontal cortex glutamate concentration. SCEDs are considered a viable alternative approach to randomised clinical trials to identify evidence-based practices when recruitment of large samples is not feasible.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 101690 0
A/Prof Sylvia Gustin
Address 101690 0
Neuroscience Research Australia
139 Barker Street, Randwick NSW 2031
Country 101690 0
Australia
Phone 101690 0
+61 293991894
Fax 101690 0
Email 101690 0
s.gustin@unsw.edu.au
Contact person for public queries
Name 101691 0
A/Prof Sylvia Gustin
Address 101691 0
Neuroscience Research Australia
139 Barker Street, Randwick NSW 2031
Country 101691 0
Australia
Phone 101691 0
+61 293991894
Fax 101691 0
Email 101691 0
s.gustin@unsw.edu.au
Contact person for scientific queries
Name 101692 0
A/Prof Sylvia Gustin
Address 101692 0
Neuroscience Research Australia
139 Barker Street, Randwick NSW 2031
Country 101692 0
Australia
Phone 101692 0
+61 293991894
Fax 101692 0
Email 101692 0
s.gustin@unsw.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
We do not have Ethics Approval to share the trial data.
What supporting documents are/will be available?
Study protocol
How or where can supporting documents be obtained?
Type [1] 7687 0
Study protocol
Citation [1] 7687 0
We will submit the study protocol to BMJ Open
Link [1] 7687 0
Email [1] 7687 0
Other [1] 7687 0
Attachment [1] 7687 0
Summary results
No Results