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"REACT-FM" Real-World Evidence From Smartphone-Based Acceptance and Commitment Therapy in Fibromyalgia

NCT05011162 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 130

Last updated 2024-06-27

No results posted yet for this study

Summary

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.

Conditions

  • Fibromyalgia

Interventions

DEVICE

Digital ACT

Study participants will receive 12 weeks of Digital Acceptance and Commitment Therapy (ACT).

Sponsors & Collaborators

  • Swing Therapeutics, Inc.

    lead OTHER

Principal Investigators

  • Brian Keefe, MD · Swing Therapeutics

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
22 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2021-07-25
Primary Completion
2024-03-05
Completion
2024-03-05
FDA Device
Yes

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05011162 on ClinicalTrials.gov