CI

At a glance

ClinicalIndex Comparison Record
Phase 2Completed· 67 enrolled
Drug / intervention
Digital ACT +1 moredevice
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT05005351
NCT05005351Phase 2Completed
CompareCT.gov

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

Swing Therapeutics, Inc.·interventional·Posted Aug 13, 2021·Updated Aug 1, 2023

In Brief

A Phase 2 clinical trial evaluating Digital ACT and Digital Symptom Tracker for Fibromyalgia. Completed, enrolled 67 participants across 7 sites.

Detailed Summary

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.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsFibromyalgia
CountriesUnited States
Collaborators--

Timeline

Phase 2CompletedFinished
202120222023202420252026
First PostedAug 13, 2021
Enrollment StartOct 28, 2020
Primary CompletionJul 9, 2021
TodayJul 2, 2026
Enrollment to primary: 8 monthsPosted 4.9 years ago

Interventions

Digital ACTdevice

Participants in Digital ACT arm complete daily ACT lessons and activities and continue their non-pharmacological and pharmacological treatment as usual.

Digital Symptom Trackerdevice

Participants in the Digital Symptom Tracker arm complete daily symptom and function tracking, have access to digital fibromyalgia and health education, and continue their non-pharmacological and pharmacological treatment as usual.