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Trial registered on ANZCTR


Registration number
ACTRN12621000997853
Ethics application status
Approved
Date submitted
15/06/2021
Date registered
29/07/2021
Date last updated
23/04/2024
Date data sharing statement initially provided
29/07/2021
Type of registration
Prospectively registered

Titles & IDs
Public title
Cognitive Behaviour Therapy Versus Mindfulness for People with Rheumatoid Arthritis
Scientific title
A randomized controlled trial of Cognitive Behaviour Therapy Versus Mindfulness on Pain Interference for People with Rheumatoid Arthritis
Secondary ID [1] 304343 0
None
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Rheumatoid Arthritis 322104 0
Condition category
Condition code
Inflammatory and Immune System 319819 319819 0 0
Rheumatoid arthritis

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
This trial aims to evaluate the efficacy of an online Cognitive Behavioural Therapy (CBT) program, and an online Mindfulness Based Stress Reduction (MBSR), compared to a waitlist control group. In addition to this, this trial will also assess whether a history of recurrent depression moderates the relative efficacy of CBT and MBSR.
Both the online MBSR and CBT programs will be guided by a registered clinical psychologist. The psychologist will attempt to contact participants each week via telephone/email for 10-15 minutes, although more time can be used where clinically required. This is to provide encouragement and ensure understanding of key program concepts. However, this therapist support will not be used to provide additional therapy. As the interventions are online, completion of each module will be automatically recorded, allowing adherence to be recorded and tracked.
Arm 1:
The online CBT intervention being used is adapted from a previously validated online CBT intervention designed for those who have chronic pain, known as the ‘Pain Course’ (Dear et al., 2013). The Pain Course materials were adapted to include fictional characters living with Rheumatoid Arthritis (RA), which were reviewed by 10 individuals with RA. The Pain Course contains five modules, which cover the following topics: (1) Pain education; (2) cognitive therapy (thought monitoring and challenging); (3) controlled breathing and pleasant activity scheduling; (4) Pacing and graded exposure; and (5) relapse prevention and goal setting. Each module spans approximately 15 minutes in length, with one module being delivered every one to two weeks. The overall intervention will span 8 weeks. There are also additional resources on topics (e.g. sleep hygiene, problem solving, assertiveness) in the form of written information. Participants will be given home-based practice tasks to complete for each of the skills introduced in the program. Participants are expected to spend at least 4 hours per week to working on the home-based tasks and practicing the skills taught in the course.

Arm 2:
The online MBSR intervention has been tailored to the needs and difficulties found among people with RA. The proposed program has been adapted from a previous MBSR online intervention for multiple sclerosis. The proposed MBSR program includes fictional case examples of characters living with RA. The characters vary in their gender, age, and experience of RA, with each depicting different symptoms and disease courses. The MBSR program consists of five modules, which cover the following topics: 1) An Introduction to Mindfulness Meditation, 2) Dealing with Stress, 3) Dealing with Difficult Sensations and Emotions, 4) Dealing with Difficult Thoughts, and 5) Mindful Communication, Compassion, and Relapse Prevention. Each module spans approximately 15 minutes in length, with one module being delivered every one to two weeks. The overall intervention will span 8 weeks. The adaptations to the program were also reviewed by 10 people with RA.
Alongside each module, participants will be directed to complete 30 minute guided meditation audio recordings daily. These have been adapted from meditation scripts of Jon Kabat-Zinn, and recorded by the research team. Lastly, participants will be encouraged to attempt informal mindfulness practice each week, and to complete weekly logs of their frequency and duration of mindfulness practice. Beyond completing the 30 minute daily formal meditation practice, there is no set time required for informal mindfulness practice and time spent on this is at the discretion of participants.
Intervention code [1] 320697 0
Treatment: Other
Intervention code [2] 320699 0
Behaviour
Comparator / control treatment
Waitlist control group who will be given access to the program of their choice (MBSR or CBT) once they finish the trial (i.e. once the 6mth follow-up questionnaires are completed).
Control group
Active

Outcomes
Primary outcome [1] 327684 0
Pain interference, as measured by the Brief Pain Inventory-Short Form
Timepoint [1] 327684 0
Baseline, post-treatment (week 8 post-intervention commencement, primary endpoint) and at a six-month follow-up
Secondary outcome [1] 396229 0
Depressive symptoms, as measured by the Patient Health Questionnaire
Timepoint [1] 396229 0
Baseline, post-treatment (week 8 post-intervention commencement) and at a six-month follow-up
Secondary outcome [2] 396230 0
Anxiety symptoms, as measured by the Generalised Anxiety Disorder Scale
Timepoint [2] 396230 0
Baseline, post-treatment (week 8 post-intervention commencement) and at a six-month follow-up
Secondary outcome [3] 396231 0
Rheumatoid arthritis symptoms, as measured using the Health Assessment Questionnaire-Disability Index
Timepoint [3] 396231 0
Baseline, post-treatment (week 8 post-intervention commencement) and at a six-month follow-up
Secondary outcome [4] 396232 0
Pain catastrophising, as measured using the Pain Catastrophizing Scale
Timepoint [4] 396232 0
Baseline, mid-treatment (week 5), post-intervention (week 8 post-intervention commencement) and at a 6-month follow-up
Secondary outcome [5] 396233 0
Pain acceptance, as measured using the Chronic Pain Acceptance Questionnaire-Short Form
Timepoint [5] 396233 0
Baseline, mid-treatment (week 5), post-intervention (week 8 post-intervention commencement) and at a 6-month follow-up
Secondary outcome [6] 396234 0
Pain self-efficacy, as measured using the 2-item Pain Self-Efficacy Questionnaire
Timepoint [6] 396234 0
Baseline, mid-treatment (week 5), post-intervention (week 8 post-intervention commencement) and at a 6-month follow-up
Secondary outcome [7] 396235 0
Mindfulness, as measured using the Five Facet Mindfulness Questionnaire- Short From
Timepoint [7] 396235 0
Baseline, mid-treatment (week 5), post-intervention (week 8 post-intervention commencement) and at a 6-month follow-up
Secondary outcome [8] 396236 0
Fear of illness progression, as measured using the Fear of Progression Questionnaire-Short Form
Timepoint [8] 396236 0
Baseline and post-treatment (week 8 post-intervention commencement)
Secondary outcome [9] 396237 0
Existential concerns, as measured using the Existential Concerns Questionnaire
Timepoint [9] 396237 0
Baseline and post-treatment (week 8 post-intervention commencement)
Secondary outcome [10] 396238 0
Interpretation bias, as measured using the ambiguous cues task
Timepoint [10] 396238 0
Baseline and post-treatment (week 8 post-intervention commencement)

Eligibility
Key inclusion criteria
Inclusion criteria:
(1) Adults with a confirmed diagnosis of Rheumatoid Arthritis (RA),
(2) currently live in Australia,
(3) have access to the internet,
(4) have functional written and spoken English,
(5) if receiving RA treatment, have been on a consistent RA treatment regime for more than one month
(6) if taking anti-depressant medication, have been on a stable dose for more than eight weeks.
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Exclusion criteria include having:
(1) suicidal intent requiring emergency care
(2) substance abuse or dependence
(3) a psychotic illness, or
(4) received consistent psychotherapy within the last 6 months.

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 was concealed using central allocation by a computer
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Randomisation will be conducted using computer-generated random numbers and will be done by an independent researcher and concealed until allocation. Random allocation will be stratified based on depression history (i.e., recurrent vs. non-recurrent depression) as assessed using the PRIME-MD.
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
A power analysis revealed that a total of 203 participants would be needed in the two treatment arms to have sufficient power (80%) to test the moderation effect. Thus, overall, we will aim to recruit 300 participants, with 120 participants in each treatment arm, and 60 in the waitlist control condition. This will allow for a drop-out rate of approximately 20%.
An intention-to-treat analysis will be used to analyse the data. To examine treatment efficacy, linear mixed models will be used, with baseline levels of treatment outcomes as the covariate, and group and depressive status as the fixed factors. Prior history of depressive disorder will also be analysed as a moderator of clinical outcomes for the two treatments.
Analyses of clinical significance will also be conducted, in line with guidelines by Dworkin et al. (2005). The proportion of participants improving by >30% (reflecting moderate improvement) and >50% (reflecting substantial improvement) will be reported for post-treatment and 6-month follow-up.
To examine whether process outcomes (e.g., pain acceptance, self-efficacy) may significantly moderate the effect of treatment, structural equation modelling will be used

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
1/08/2021
Actual
1/08/2021
Date of last participant enrolment
Anticipated
Actual
10/04/2023
Date of last data collection
Anticipated
Actual
12/12/2023
Sample size
Target
300
Accrual to date
Final
304
Recruitment in Australia
Recruitment state(s)
ACT,NSW,NT,QLD,SA,TAS,WA,VIC

Funding & Sponsors
Funding source category [1] 308715 0
University
Name [1] 308715 0
The University of Sydney
Country [1] 308715 0
Australia
Primary sponsor type
University
Name
The University of Sydney
Address
The University of Sydney, NSW 2006
Country
Australia
Secondary sponsor category [1] 309607 0
None
Name [1] 309607 0
Address [1] 309607 0
Country [1] 309607 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 308640 0
The University of Sydney Human Research Ethics Committee
Ethics committee address [1] 308640 0
Ethics committee country [1] 308640 0
Australia
Date submitted for ethics approval [1] 308640 0
15/06/2021
Approval date [1] 308640 0
31/07/2021
Ethics approval number [1] 308640 0
2021/516

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

Contacts
Principal investigator
Name 111398 0
Prof Louise Sharpe
Address 111398 0
Room 450, Brennan MacCallum Building, A18, The University of Sydney NSW 2006 Australia
Country 111398 0
Australia
Phone 111398 0
+61 29351 4558
Fax 111398 0
Email 111398 0
louise.sharpe@sydney.edu.au
Contact person for public queries
Name 111399 0
Rachel Menzies
Address 111399 0
Room 423, Brennan MacCallum Building, The University of Sydney NSW 2006 Australia
Country 111399 0
Australia
Phone 111399 0
+61 29351 2908
Fax 111399 0
Email 111399 0
rmen9233@uni.sydney.edu.au
Contact person for scientific queries
Name 111400 0
Rachel Menzies
Address 111400 0
Room 423, Brennan MacCallum Building, The University of Sydney NSW 2006 Australia
Country 111400 0
Australia
Phone 111400 0
+61 29351 2908
Fax 111400 0
Email 111400 0
rmen9233@uni.sydney.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?
All de-identified data on which a report was published will be shared.
When will data be available (start and end dates)?
Data will be available from the date of publication of such a report (no end date).
Available to whom?
Data will be available to other researchers upon request.
Available for what types of analyses?
Data will be available for replication of the report’s analyses and/or novel analyses to explore potential alternative explanations based on the data.
How or where can data be obtained?
Data will be made available to other researchers electronically (through emailing louise.sharpe@sydney.edu.au).


What supporting documents are/will be available?

Doc. No.TypeCitationLinkEmailOther DetailsAttachment
22278Study protocolhttps://bmjopen.bmj.com/content/12/5/e056504.abstract  



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.