NCT05243511已完成3 期
"PROSPER-FM": Prospective Study to Evaluate a Digital Regimen for Fibromyalgia Management
适应症
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 275
- 试验地点
- 50
- 主要终点
- Patient Global Impression of Change (PGIC) response rate
研究概览
简要总结
PROSPER-FM is a multi-center, randomized, non-significant risk device study to evaluate the safety and efficacy of two digital therapy smartphone applications in participants with fibromyalgia. Eligible participants are randomized (1:1) to either the Digital Acceptance and Commitment Therapy (Digital ACT) group or the Digital Symptom Tracker group and receive assigned therapy for 12 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 (Participant, Care Provider, Outcomes Assessor)
入排标准
- 年龄范围
- 22 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Participant is 22 to 75 years of age, inclusive
- •Participant has a diagnosis of primary FM as defined by the 2016 American College of Rheumatology Preliminary Diagnostic Criteria for FM
- •Participants with ongoing treatments should be on stable therapy for 30 days prior to screening appointment.
- •Participant is capable of reading and understanding English and has provided written informed consent to participate.
排除标准
- •Lifetime history of bipolar or other psychotic disorder
- •Severe depression at screening (measured by BDI-II)
- •The participant is at increased risk of suicide on the basis of the investigator's judgment or the Columbia-Suicide Severity Rating Scale ("C-SSRS")
- •Participant has any other disease or medical condition that, in the opinion of the Investigator or Sponsor, could endanger the participant, interfere with the evaluation of the study device's efficacy or safety, or compromise the participant's ability to comply with/complete the study.
结局指标
主要结局
Patient Global Impression of Change (PGIC) response rate
时间窗: Week 12
次要结局
未报告次要终点
研究者
研究点 (50)
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