Completed

SMART-FM"SMART-FM": Smart-Phone Based Digital Therapeutic for Management of Fibromyalgia

What is being tested

Digital ACT

+ Digital Symptom Tracker

Device

Who is being recruted

Fibromyalgia+3

+ Muscular Diseases

+ Musculoskeletal Diseases

From 22 to 75 Years

+5 Eligibility Criteria

See all eligibility criteria

How is the trial designed

Treatment Study

Phase 2

Interventional

Study Start: October 2020

See protocol details

Summary

Principal SponsorSwing Therapeutics, Inc.

Last updated: January 28, 2026

Sourced from a government-validated database.Claim as a partner

Study start date: October 28, 2020

Actual date on which the first participant was enrolled.

This is a non-significant risk, multi-center, randomized, active-controlled study to compare the effectiveness of two digital therapies in the management of fibromyalgia over 12 weeks. The primary endpoint is mean change from baseline to Week 12 in the weekly revised Fibromyalgia Impact Questionnaire (FIQ-R) total score.

Official Title"SMART-FM": Smart-Phone Based Digital Therapeutic for Management of Fibromyalgia

NCT05005351

Principal SponsorSwing Therapeutics, Inc.

Last updated: January 28, 2026

Sourced from a government-validated database.Claim as a partner

Protocol

This section provides details of the study plan, including how the study is designed and what the study is measuring.

Design Details

67 patients to be enrolled

Total number of participants that the clinical trial aims to recruit.

Treatment Study

These studies test new ways to treat a disease, condition, or health issue. The goal is to see if a new drug, therapy, or approach works better or has fewer side effects than existing options.

Eligibility

Researchers look for people who fit a certain description, called eligibility criteria: person's general health condition or prior treatments.

Conditions

Criteria

Any sex

Biological sex of participants that are eligible to enroll.

From 22 to 75 Years

Range of ages for which participants are eligible to join.

Healthy volunteers not allowed

If individuals who are healthy and do not have the condition being studied can participate.

Conditions

Pathology

FibromyalgiaMuscular DiseasesMusculoskeletal DiseasesNervous System DiseasesNeuromuscular DiseasesRheumatic Diseases

Criteria

5 exclusion criteria prevent from participating

Lifetime history of bipolar disorder as assessed by the MINI.

Current, untreated, major depressive episode and/or anxiety disorders as assessed by the MINI.

Subject has a BDI-II total score > 25 at either the Screening appointment or Baseline appointment.

The subject is at increased risk of suicide on the basis of the investigator's judgment, a response > 1 to BDI item #9, or the results of the Columbia-Suicide Severity Rating Scale ("C-SSRS") conducted at Screening or Baseline (i.e., any suicidal behavior during the preceding year or C-SSRS Type 3, 4, or 5 suicidal ideation during the preceding year).

Show More Criteria

Study Plan

Find out more about all the medication administered in this study, their detailed description and what they involve.

Treatment Groups

Study Objectives

2 intervention groups are designated in this study

This study does not include a placebo group

Treatment Groups

Group I

Active Comparator

Group II

Active Comparator

Study Objectives

Primary Objectives

Secondary Objectives

Study Centers

These are the hospitals, clinics, or research facilities where the trial is being conducted. You can find the location closest to you and its status.

This study has 7 locations

Suspended

Excell Research, Inc.

Oceanside, United StatesOpen Excell Research, Inc. in Google Maps

Suspended

Superior Research LLC

Sacramento, United States

Suspended

Clinical Neuroscience Solutions, Inc.

Orlando, United States

Suspended

Upstate Clinical Research Associates LLC

Williamsville, United States

Completed7 Study Centers