临床试验/NCT05433337

NCT05433337已完成不适用

"PROSPER-FM-EXT": Prospective Study to Evaluate a Digital Regimen for Fibromyalgia Management: An Extension Study

Swing Therapeutics, Inc.1 个研究点分布在 1 个国家目标入组 60 人开始时间: 2022年6月8日最近更新: 2024年6月27日

适应症

干预措施

试验速览

阶段: 不适用
状态: 已完成
发起方: Swing Therapeutics, Inc.
入组人数: 60
试验地点: 1
主要终点: Patient Global Impression of Change (PGIC)

研究概览研究设计入排标准研究组 & 干预措施结局指标研究者研究点记录与标识符相似试验

研究概览

简要总结

This study is designed as a 9-month extension of the original study (PROSPER-FM). The purpose of the extension study is to assess the long-term (up to 1 year) response to a digital therapy in the treatment of fibromyalgia.

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 75 Years（Adult, Older Adult）
性别: All
接受健康志愿者: 否

入选标准

•Participant has completed participation in the PROSPER-FM study and was assigned to the Digital ACT Arm
•Participant is willing and able to comply with all protocol-specified requirements

排除标准

•Based on the investigator's judgment, any new diagnosis of acute or chronic disease/condition since participant's enrollment in PROSPER-FM study that may impact the outcome of this study
•Severe depression at the final visit of the PROSPER-FM study (measured by BDI-II)
•Increased risk of suicide on the basis of the investigator's judgment or the Columbia-Suicide Severity Rating Scale ("C-SSRS") at the final visit of the PROSPER-FM study

研究组 & 干预措施

Digital Acceptance and Commitment Therapy (ACT) Arm

Other

干预措施: Digital ACT (Device)

结局指标

主要结局

Patient Global Impression of Change (PGIC)

时间窗: Month 9

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(Original Study Baseline to Month 9)

研究者

发起方

Swing Therapeutics, Inc.

申办方类型

Other

责任方

Sponsor

研究点 (1)

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