a tailored psychological intervention (mitig.ra) for managing fatigue in rheumatoid arthritis

Conditions: Rheumatoid Arthritis

Summary: the objective of this study is to examine the efficacy of the compassion and mindfulness intervention for ra (mitig.ra), 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 (mitig.ra + tau) or control condition (tau) using computer-randomization. mitig.ra 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.

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.

Eligibility criteria:
inclusion criteria: * fulfilling the 1987 acr or 2010 acr/eular classification criteria for ra; * in pga-near remission: tender and swollen 28 joint counts and c-reactive protein (crp) (mg/dl) \ 1, * raid - fatigue ≥ 3; * pess \< "good" * under stable medication (at least 3 months). exclusion criteria: * less than 6 years of formal education; * unable to attend zoom meetings unaided; * unable to fulfil self-report questionnaires unaided; * pain-related comorbidities (e.g. fibromyalgia or osteoarthritis) * presence of other comorbid medical conditions that may cause fatigue, such as anaemia (hb\<10mg/dl), uncontrolled hypothyroidism or cancer; * presence of severe psychological symptoms or disorders (e.g. psychosis, severe depression, substance abuse); * currently ongoing psychological interventions or formal psychiatric treatment; * pregnant patients; * otherwise disabled patients (advanced articular/bone erosion); * refuse to provide informed consent.

Keywords: contextual-cognitive behavioural fatigue