A Tailored Psychological Intervention (MITIG.RA) for Managing Fatigue in Rheumatoid Arthritis: Protocol for a Randomized Controlled Trial
Overview
- Phase
- N/A
- Intervention
- Not specified
- Conditions
- Rheumatoid Arthritis
- Sponsor
- Centro Hospitalar e Universitário de Coimbra, E.P.E.
- Enrollment
- 120
- Primary Endpoint
- Fatigue
- Status
- Not Yet Recruiting
- Last Updated
- 2 years ago
Overview
Brief 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.
Detailed Description
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.
Investigators
José António Pereira da Silva
Professor
Centro Hospitalar e Universitário de Coimbra, E.P.E.
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, and Patient Global Assessment of disease Activity (PGA \> 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.
Outcomes
Primary Outcomes
Fatigue
Time Frame: Week 32
Fatigue levels will be assessed by the 0-10 numerical rating scale assessing fatigue as part of the RAID.7.Higher Scores indicate higher levels of fatigue
Secondary Outcomes
- Perceived Impact of the Disease(Week 32)
- Self-Compassion(Week 32)
- Affective Mindfulness(Week 32)
- Adverse Events(Week 32)
- Satisfaction With Disease Status- PESS(Week 32)
- Anxiety and Depression Levels(Week 32)