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Cognitive Behaviour Therapy Versus Mindfulness for People with Rheumatoid Arthritis

A randomized controlled trial of Cognitive Behaviour Therapy Versus Mindfulness on Pain Interference for People with Rheumatoid Arthritis

Status
Completed
Phases
Unknown
Study type
Interventional
Source
ANZCTR
Registry ID
ACTRN12621000997853
Enrollment
304
Registered
2021-07-29
Start date
2021-08-01
Completion date
2023-04-10
Last updated
2024-04-29

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

None listed

Brief summary

The current study aims to assess the efficacy of online CBT and MBSR interventions for people with Rheumatoid Arthritis and to see whether the effectiveness of these interventions is moderated by recurrent depression. It is expected that both CBT and MBSR will reduce pain interference, depression and anxiety relative to a waitlist control, but that MBSR will be more effective than CBT amongst those who also have recurrent depression.

Interventions

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 teleph

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.

Sponsors

The University of Sydney
Lead SponsorUniversity

Study design

Allocation
Randomised controlled trial
Intervention model
Parallel
Primary purpose
Treatment
Masking
Blinded (masking used) (Investigator)

Eligibility

Sex/Gender
All
Age
18 Years to No maximum
Healthy volunteers
No

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.

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.

Outcome results

None listed

Source: ANZCTR · Data processed: Feb 12, 2026