MITIG.RA: study protocol of a tailored psychological intervention for managing fatigue in rheumatoid arthritis randomized controlled trial

Trials

Study Protocol

Ana M. Pinto¹  Ruben L. F. Spilker²  Ricardo J. O. Ferreira³  Cláudia Paiva⁴  José A. Pereira da Silva⁵  Cátia Duarte⁵ 

[1] Centre for Research in Neuropsychology and Cognitive and Behavioural Intervention (CINEICC), Faculty of Psychology and Educational Sciences, University of Coimbra, Coimbra, Portugal;Institute of Psychological Medicine, Faculty of Medicine, University of Coimbra, Coimbra, Portugal;Faculty of Medicine, University of Coimbra, Coimbra, Portugal;Nursing Research, Innovation and Development Centre of Lisbon (CIDNUR), Nursing School of Lisbon (ESEL), Lisbon, Portugal;Rheumatology Department, Centro Hospitalar E Universitário de Coimbra, Coimbra, Portugal;Rheumatology Department, Centro Hospitalar E Universitário de Coimbra, Coimbra, Portugal;Faculty of Medicine, Coimbra Institute for Clinical and Biomedical Research (iCBR), University of Coimbra, Coimbra, Portugal;

关键词: Rheumatoid arthritis;    Fatigue;    Psychotherapy;    Mindfulness;    Self-compassion;    Acceptance and commitment therapy;   

DOI  :  10.1186/s13063-023-07692-4

 received in 2023-07-24, accepted in 2023-09-29,  发布年份 2023

来源: Springer

【 摘 要 】

BackgroundDespite remarkable medical advances in the treatment of rheumatoid arthritis (RA), a subset of patients fails to achieve complete clinical remission, as the Patient Global Assessment (PGA) of disease activity remains above 1, even after the inflammatory process is brought under control. This so-called state of ‘PGA-near-remission’ negatively impacts individuals’ functioning and potentiates inadequate care. Fatigue is a distressing and disabling symptom frequently reported by patients in PGA-near-remission, and its management remains challenging. While classic cognitive-behavioural interventions show some benefits in managing fatigue, there is potential for improvement. Recently, contextual-cognitive behavioural therapies (CCBT), like mindfulness, acceptance, and compassion-based interventions, have shown promising results in fatigue-associated disorders and their determinants. This study primarily aims to examine the efficacy of the Compassion and Mindfulness Intervention for RA (MITIG.RA), a novel intervention combining different components of CCBT, compared to treatment-as-usual (TAU) in the management of RA-associated fatigue. Secondary aims involve exploring whether MITIG.RA produces changes in the perceived impact of disease, satisfaction with disease status, levels of depression, and emotion-regulation skills.MethodsThis is a single center, two-arm parallel randomized controlled trial. Patients will be screened for eligibility and 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 h, followed by two booster sessions. Outcomes will be assessed through validated self-report measures, including 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 sessions (weeks 12 and 20, respectively), and at 32 and 44 weeks after the interventions’ beginning.DiscussionWe expect MITIG.RA to be effective in reducing levels of RA-associated fatigue. Secondarily, we hypothesize that the experimental group will show improvements in the overall perceived impact of disease, emotional distress, and emotion regulation skills. Our findings will contribute to determine the benefits of combining CCBT approaches for managing fatigue and associated distress in RA.Trial registrationClinicalTrials.gov NCT05389189. Registered on May 25, 2022.

【 授权许可】

CC BY   
© BioMed Central Ltd., part of Springer Nature 2023