Primary aim: to investigate the impact of the program Compassion and Mindfulness Intervention for RA (MITIG.RA) 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 MITIG.RA 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.
