Gallego Ana, Serrat Mayte, Royuela-Colomer Estíbaliz, Sanabria-Mazo Juan P, Borràs Xavier, Esteve Montserrat, Grasa Mar, Rosa Araceli, Rozadilla-Sacanell Antoni, Almirall Miriam, D'Amico Francesco, Dai Yifei, Rosenbluth Michael J, McCracken Lance M, Navarrete Jaime, Feliu-Soler Albert, Luciano Juan V
Department of Psychology, Faculty of Education and Psychology, University of Jyväskylä, Jyväskylä, Finland.
School of Wellbeing, JYU.Well, University of Jyväskylä, Jyväskylä, Finland.
Digit Health. 2024 Mar 27;10:20552076241239177. doi: 10.1177/20552076241239177. eCollection 2024 Jan-Dec.
Fibromyalgia (FM) is a prevalent pain syndrome with significant healthcare and societal costs. The aim of the SMART-FM-SP study is to determine the effectiveness, cost-utility, and physiological effects in patients with FM of a digital intervention (STANZA®) currently marketed in the United States, which delivers smartphone-based, fully self-guided Acceptance and Commitment Therapy (Digital ACT) for treating FM-related symptoms.
A single-site, parallel-group, superiority, randomized controlled trial (RCT) will be conducted, including a total of 360 adults diagnosed with FM. Individuals will be randomly allocated (1:1:1) to treatment as usual (TAU), to TAU plus 12 weeks of treatment with Digital ACT, or to TAU plus 12 weeks of treatment with digital symptom tracking (i.e. FibroST). Participants will be assessed at baseline, post-treatment, and 6-month follow-up. An intention-to-treat analysis using linear mixed models will be computed to analyze the effects of Digital ACT on functional impairment (primary outcome), as measured by the Fibromyalgia Impact Questionnaire Revised at 6 months from the inception of the treatment. Secondary outcomes include impression of change, symptoms of distress, pain catastrophising, quality of life, cost-utility, and selected biomarkers (cortisol and cortisone, immune-inflammatory markers, and FKBP5 gene polymorphisms). The role of ACT-related processes of change will be tested with path analyses.
This study is the first RCT that tests Digital ACT for Spanish patients with FM. Results will be important not only for patients and clinicians, but also for policy makers by examining the cost-utility of the app in a public healthcare context.
纤维肌痛（FM）是一种普遍存在的疼痛综合征，会产生高昂的医疗和社会成本。SMART-FM-SP研究的目的是确定一种目前在美国销售的数字干预措施（STANZA®）对FM患者的有效性、成本效益和生理影响，该干预措施提供基于智能手机的完全自主引导的接受与承诺疗法（数字ACT）来治疗FM相关症状。
将进行一项单中心、平行组、优效性随机对照试验（RCT），共纳入360名被诊断为FM的成年人。个体将被随机分配（1:1:1）至常规治疗（TAU）组、TAU加12周数字ACT治疗组或TAU加12周数字症状跟踪（即FibroST）治疗组。参与者将在基线、治疗后和6个月随访时进行评估。将使用线性混合模型进行意向性分析，以分析数字ACT对功能损害（主要结局）的影响，功能损害通过治疗开始后6个月修订的纤维肌痛影响问卷进行测量。次要结局包括变化印象、痛苦症状、疼痛灾难化、生活质量、成本效益以及选定的生物标志物（皮质醇和可的松、免疫炎症标志物以及FKBP5基因多态性）。将通过路径分析测试与ACT相关的改变过程的作用。
本研究是首个针对西班牙FM患者测试数字ACT的RCT。研究结果不仅对患者和临床医生很重要，而且通过在公共医疗背景下检验该应用程序的成本效益，对政策制定者也很重要。
