Primary aim: to investigate the impact of the program Compassion and Mindfulness Intervention for RA (CoMIRA) in RA-associated fatigue in comparison to treatment as usual (TAU).~Secondary aims: the effects the intervention has upon the patient's satisfaction with disease status, overall perceived impact of disease, depression and anxiety levels, and self-compassion skills.~Methods Selection of patients: Adult patients with RA, currently in PGA-near-remission; Rheumatoid Arthritis Impact of disease (RAID) - fatigue ≥ 3; Patient Experienced Symptom State (PESS) < good and under stable medication (at least 3 months).~Study design: two-arm parallel superiority randomized controlled trial. Participants will be randomized (1:1) into one of two conditions: the experimental condition (CoMIRA Program plus TAU]) and the control condition (TAU only).~Intervention: delivered in a group sessions, online, for eight consecutive weeks, followed by two booster sessions after 4 and 12 additional weeks.~Active Group: The CoMIRA program incorporates the following key topics during the 8 weeks of intervention (1st phase):~(i) Psychoeducation on RA, sleep hygiene, exercise, and general nutritional recommendations (promote behavioural change and self-care, boost the sense of self-worth and self-efficacy) (ii) Activity engagement and pacing (iii) The functioning of the mind and its problematic patterns (iv) Focusing on the 'here and now' (mindfulness) (v) Learning new ways of self-relating - self-compassion (vi) Making room for suffering (acceptance); and (vii) Moving towards what matters (identification of valued life directions and promotion of consistent values and goals-directed behaviour).~The closing session comprises a review of the main concepts and take-home messages, discussion of potential setbacks and strategies to deal with them, and participant's feedback on the intervention and the progress made.~The booster sessions, at 4 and 12 weeks after completion of the first phase, will focus on the revision of previously learned concepts, evaluation of potential barriers/difficulties encountered, strategies employed to deal with them, and clarification of any impending question.~Comparison: Usual Care~Procedure: The participants who accept to participate will be randomized (1:1). sessions will be delivered via zoom, in a group format. Patients will be assessed at baseline, post-intervention, before the first and second booster session (week 12 and 20, respectively), and at 32 and 44 weeks after the interventions' beginning.~Analysis: An intention-to-treat analysis will be conducted whenever possible and complemented with per-protocol analysis if needed. Analysis of covariance (ANCOVA) will be used to assess between-group differences in fatigue scores (the primary outcome) at 3-month follow-up after the second booster session (32nd week), controlling for baseline values. The same analytic procedure will be used to examine between-group differences in perceived disease activity, depression, mindfulness, and self-compassion (secondary outcomes) at the 32nd week. All effect sizes will be reported.
The objective of this study is to examine the efficacy of the Compassion and Mindfulness Intervention for RA (CoMIRA), a novel intervention combining different components of Cognitive Behavioural Therapy (CBT), compared to treatment-as-usual (TAU) in the management of Rheumatoid Arthritis (RA) associated fatigue.~This is a multicentre, two-arm parallel randomized controlled trial. Patients will be screened for eligibility, willingness to participate, and will be assessed and randomized to the experimental (CoMIRA + TAU) or control condition (TAU) using computer-randomization. CoMIRA will be delivered by a certified psychologist and comprises eight sessions of 2 hours, followed by two booster sessions. Outcomes will be assessed via validated self-report measures and include levels of fatigue (primary outcome), perceived impact of disease, depressive symptoms, mindfulness, self-compassion, safety, and satisfaction (secondary outcomes). Assessment will take place at baseline, post-intervention, before the first and second booster session (week 12 and 20, respectively), and at 32 and 44 weeks after the interventions' beginning.