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Prospective Study to Evaluate a Digital Regimen for Fibromyalgia Management

NCT05243511 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 275

Last updated 2023-06-15

No results posted yet for this study

Summary

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.

Conditions

  • Fibromyalgia

Interventions

DEVICE

Digital ACT

Participants in this arm receive Digital ACT as well as standard of care.

OTHER

Digital Symptom Tracker

Participants in this arm complete a digital symptom and function tracker and monitor, are provided access to digital fibromyalgia and health education, and receive standard of care.

Sponsors & Collaborators

  • Swing Therapeutics, Inc.

    lead OTHER

Principal Investigators

  • Michael Gendreau, MD · Consulting Chief Medical Officer

  • Lesley Arnold, MD · Study Principal Investigator

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Model
PARALLEL

Eligibility

Min Age
22 Years
Max Age
75 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2022-02-08
Primary Completion
2023-05-15
Completion
2023-05-15
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 NCT05243511 on ClinicalTrials.gov