Authors
»
The University of Sydney -More
Category
»
Primary study
Registry of Trials»ANZCTR
Year
»
2021
INTERVENTION: 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 t CONDITION: Inflammatory and Immune System ‐ Rheumatoid arthritis Rheumatoid Arthritis; ; Rheumatoid Arthritis PRIMARY OUTCOME: Pain interference, as measured by the Brief Pain Inventory‐Short Form[Baseline, post‐treatment (week 8 post‐intervention commencement, primary endpoint) and at a six‐month follow‐up] 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. SECONDARY OUTCOME: Anxiety symptoms, as measured by the Generalised Anxiety Disorder Scale[Baseline, post‐treatment (week 8 post‐intervention commencement) and at a six‐month follow‐up] Depressive symptoms, as measured by the Patient Health Questionnaire[Baseline, post‐treatment (week 8 post‐intervention commencement) and at a six‐month follow‐up] Existential concerns, as measured using the Existential Concerns Questionnaire[Baseline and post‐treatment (week 8 post‐intervention commencement)] Fear of illness progression, as measured using the Fear of Progression Questionnaire‐Short Form[Baseline and post‐treatment (week 8 post‐intervention commencement) ] Interpretation bias, as measured using the ambiguous cues task[Baseline and post‐treatment (week 8 post‐intervention commencement)] Mindfulness, as measured using the Five Facet Mindfulness Questionnaire‐ Short From[Baseline, mid‐treatment (week 5), post‐intervention (week 8 post‐intervention commencement) and at a 6‐month follow‐up] Pain acceptance, as measured using the Chronic Pain Acceptance Questionnaire‐Short Form[Baseline, mid‐treatment (week 5), post‐intervention (week 8 post‐intervention commencement) and at a 6‐month follow‐up] Pain catastrophising, as measured using the Pain Catastrophizing Scale [Baseline, mid‐treatment (week 5), post‐intervention (week 8 post‐intervention commencement) and at a 6‐month follow‐up] Pain self‐efficacy, as measured using the 2‐item Pain Self‐Efficacy Questionnaire[Baseline, mid‐treatment (week 5), post‐intervention (week 8 post‐intervention commencement) and at a 6‐month follow‐up] Rheumatoid arthritis symptoms, as measured using the Health Assessment Questionnaire‐Disability Index[Baseline, post‐treatment (week 8 post‐intervention commencement) and at a six‐month follow‐up]
Epistemonikos ID: 58c6b14db06c043e5e7464b26f0f32e69877a857
First added on: Aug 25, 2024