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.
Trials. 2023 Oct 6;24(1):651. doi: 10.1186/s13063-023-07692-4.
Despite 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.
This 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.
We 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.
ClinicalTrials.gov NCT05389189. Registered on May 25, 2022.
尽管类风湿关节炎 (RA) 的治疗在医学上取得了显著进展，但仍有一部分患者无法达到完全临床缓解，因为即使炎症过程得到控制，患者的整体疾病活动评估 (PGA) 仍高于 1。这种所谓的“PGA 接近缓解”状态会对个人的功能产生负面影响，并导致护理不足。疲劳是 PGA 接近缓解患者经常报告的一种痛苦和使人丧失能力的症状，其管理仍然具有挑战性。虽然经典的认知行为干预在管理疲劳方面显示出一些益处，但仍有改进的空间。最近，基于正念、接纳和慈悲的语境认知行为疗法 (CCBT) 已在与疲劳相关的疾病及其决定因素方面显示出有希望的结果。本研究主要旨在检验一种新的干预措施——类风湿关节炎的慈悲与正念干预 (MITIG.RA) 的疗效，该干预措施结合了 CCBT 的不同成分，与常规治疗 (TAU) 相比，用于治疗 RA 相关疲劳。次要目标包括探索 MITIG.RA 是否会改变疾病的感知影响、对疾病状况的满意度、抑郁水平和情绪调节技能。
这是一项单中心、两臂平行随机对照试验。将对患者进行筛选，以确定其是否符合纳入标准并愿意参加，并通过计算机随机化将其评估和随机分配到实验组 (MITIG.RA+TAU) 或对照组 (TAU)。MITIG.RA 将由认证心理学家提供，包括八节 2 小时的课程，随后是两次强化课程。通过验证的自我报告措施评估结果，包括疲劳（主要结果）、疾病感知影响、抑郁症状、正念、自我慈悲、安全性和满意度（次要结果）。评估将在基线、干预后、第一次和第二次强化课程前（分别在第 12 周和第 20 周）以及干预开始后 32 周和 44 周进行。
我们预计 MITIG.RA 能有效降低 RA 相关疲劳水平。其次，我们假设实验组在整体疾病感知影响、情绪困扰和情绪调节技能方面会有所改善。我们的研究结果将有助于确定结合 CCBT 方法治疗 RA 疲劳及其相关困扰的益处。
ClinicalTrials.gov NCT05389189。注册于 2022 年 5 月 25 日。
