A Tailored Psychological Intervention (MITIG.RA) for Managing Fatigue in Rheumatoid Arthritis: Protocol for a Randomized Controlled Trial
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- 入组人数
- 120
- 主要终点
- Fatigue
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Triple (Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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).
排除标准
- •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.
结局指标
主要结局
Fatigue
时间窗: 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
次要结局
- 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)
研究者
José António Pereira da Silva
Professor
Centro Hospitalar e Universitário de Coimbra, E.P.E.