NCT05011162已完成不适用
"REACT-FM" Real-World Evidence From Smartphone-Based Acceptance and Commitment Therapy in Fibromyalgia
适应症
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 130
- 试验地点
- 2
- 主要终点
- Patient Global Impression of Change (PGIC) Response
研究概览
简要总结
The objective of this study is to assess the clinical impact of a digital therapy for the management of fibromyalgia. Study participants receive 12 weeks of Digital Acceptance and Commitment Therapy (ACT) in addition to their standard care for fibromyalgia. The primary endpoint is the Patient Global Impression of Change (PGIC) at week 12. This is a virtual, single-arm, pragmatic, non-significant risk study.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 22 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Participant is 22 years of age or older
- •Participant has a diagnosis of fibromyalgia based on self-reported responses to 2016 ACR criteria for fibromyalgia diagnosis
- •Participant is capable of reading and understanding English and has provided written informed consent to participate (signed electronically).
排除标准
- •Participant is not a resident of the United States
- •In the opinion of the Investigator or Sponsor, the participant suffers from a severe psychiatric condition
- •Participant has a diagnosis of, or is being treated for any type of Dementia (Parkinson's disease, Alzheimer's Disease, Huntington's Disease, Lewy Body Dementia, Creuztfeldt-Jacob Disease, Frontotemporal Dementia, Korsakoff Syndrome, Vascular Dementia) or a current diagnosis of cancer or recurrence in the past 3 years (other than basal or squamous cell skin cancer)
结局指标
主要结局
Patient Global Impression of Change (PGIC) Response
时间窗: Week 12
PGIC scores included are: Very much improved, much improved, minimally improved, no change, minimally worse, much worse, very much worse
次要结局
- Revised Fibromyalgia Impact Questionnaire (FIQ-R) symptoms domain score(Baseline to Week 12)
- Revised Fibromyalgia Impact Questionnaire (FIQ-R) impact domain score(Baseline to Week 12)
- Revised Fibromyalgia Impact Questionnaire (FIQ-R) total score(Baseline to Week 12)
- Revised Fibromyalgia Impact Questionnaire (FIQ-R) function domain score(Baseline to Week 12)
- Participant's self-reported average weekly pain score, recorded on an NRS scale(Baseline to Week 12)
- Participant's self-reported average weekly pain interference score, recorded on an NRS scale(Baseline to Week 12)
- Participant's compliance with the Digital ACT device(Weeks 1-12)
- Participant's self-reported weekly sleep interference score, recorded on an NRS scale(Baseline to Week 12)
- Participant's engagement with the Digital ACT device(Weeks 1-12)
研究者
研究点 (2)
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