Prospective Study to Evaluate a Digital Regimen for Fibromyalgia Management

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.

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Key information

Conditions

Fibromyalgia Muscular Diseases Musculoskeletal Diseases Nervous System Diseases Neuromuscular Diseases Rheumatic Diseases

Age range

22 year–75 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

Site #37, Covina, California, United States

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Key Inclusion Criteria:

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.

Key Exclusion Criteria:

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.

Treatment and study plan

Digital ACT

Device

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

Digital Symptom Tracker

Other

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.

Primary outcomes

Patient Global Impression of Change (PGIC) response rate

Time frame: Week 12

Sponsors and collaborators

Lead sponsor

Swing Therapeutics, Inc.

Other

Registry information

Official study title

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

Acronym: PROSPER-FM

Important dates

Study start: 2022
Primary completion: 2023
Study completion: 2023
First posted: Feb 17, 2022
Registry last updated: Jun 15, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.

Completed