NCT05149222已完成不适用
"REACT-FM-EXT": Real-World Evidence From Smartphone-Based Acceptance and Commitment Therapy in Fibromyalgia: An Extension Study
适应症
干预措施
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 50
- 试验地点
- 1
- 主要终点
- The primary efficacy endpoint is the response rate to Patient Global Impression of Change (PGIC).
研究概览
简要总结
This is an extension study of REACT-FM. The primary objective of the study is to assess the response to digital therapy in the treatment of fibromyalgia over an additional 9 months.
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 has completed participation in the REACT-FM study.
- •Participant has completed 41 sessions within Tempo in the REACT-FM study and is willing and able to comply with all protocol-specified requirements.
- •Participant has provided informed consent to participate.
- •Participant continues to meet original safety criteria for the REACT-FM study.
排除标准
- 未提供
研究组 & 干预措施
Digital Acceptance and Commitment Therapy (ACT) Arm
Other
Pragmatic
干预措施: Digital ACT (Device)
结局指标
主要结局
The primary efficacy endpoint is the response rate to Patient Global Impression of Change (PGIC).
时间窗: 9 months
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) total score(Enrollment to Month 9)
- Participant's self-reported weekly sleep interference score, recorded on an NRS scale(Enrollment to Month 9)
- Participant's self-reported average weekly pain interference score, recorded on an NRS(Enrollment to Month 9)
- Participant's self-reported average weekly pain score, recorded on an NRS scale(Enrollment to Month 9)
- Revised Fibromyalgia Impact Questionnaire (FIQ-R) symptoms domain score(Enrollment to Month 9)
- Revised Fibromyalgia Impact Questionnaire (FIQ-R) function domain score(Enrollment to Month 9)
- Revised Fibromyalgia Impact Questionnaire (FIQ-R) impact domain score(Enrollment to Month 9)
研究者
研究点 (1)
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