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Digital Acceptance and Commitment Therapy (ACT) Arm for Fibromyalgia (REACT-FM Trial)
N/A
Waitlist Available
Led By Steph Catella, PsyD
Research Sponsored by Swing Therapeutics, Inc.
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up weeks 1-12
Awards & highlights
REACT-FM Trial Summary
This trial is testing whether a digital therapy can help manage fibromyalgia. The therapy is given for 12 weeks in addition to the person's standard care. The primary endpoint is the Patient Global Impression of Change (PGIC) at week 12.
Eligible Conditions
- Fibromyalgia
REACT-FM Trial Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ weeks 1-12
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~weeks 1-12
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Patient Global Impression of Change (PGIC) Response
Secondary outcome measures
Participant's compliance with the Digital ACT device
Participant's engagement with the Digital ACT device
Participant's self-reported average weekly pain interference score, recorded on an NRS scale
+6 moreSide effects data
From 2021 Phase 2 trial • 67 Patients • NCT050053513%
Exacerbation of Fibromyalgia Pain
3%
Anxiety
3%
Post COVID-19 Vaccination Syndrome
3%
Left Side Rib Contusions
3%
Exacerbation of Gastroparesis
3%
Headache
3%
Fever
3%
Broken Foot
3%
Worsening Anemia
3%
Vertigo
100%
80%
60%
40%
20%
0%
Study treatment Arm
Digital Acceptance and Commitment Therapy (ACT) Arm
Digital Symptom Tracker Arm
REACT-FM Trial Design
1Treatment groups
Experimental Treatment
Group I: Digital Acceptance and Commitment Therapy (ACT) ArmExperimental Treatment1 Intervention
Pragmatic
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Digital ACT
2022
Completed Phase 3
~350
Find a Location
Who is running the clinical trial?
Swing Therapeutics, Inc.Lead Sponsor
4 Previous Clinical Trials
3,202 Total Patients Enrolled
4 Trials studying Fibromyalgia
3,202 Patients Enrolled for Fibromyalgia
Steph Catella, PsyDPrincipal InvestigatorSwing Therapeutics
Brian Keefe, MDPrincipal InvestigatorSwing Therapeutics
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- You have a serious mental health condition, as determined by the researcher or sponsor of the study.You have been diagnosed with any type of dementia or have had cancer within the past three years, except for basal or squamous cell skin cancer.
Research Study Groups:
This trial has the following groups:- Group 1: Digital Acceptance and Commitment Therapy (ACT) Arm
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Fibromyalgia Patient Testimony for trial: Trial Name: NCT05011162 — N/A
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Can people with illnesses join this research project currently?
"The most recent information available indicates that this study is still recruiting patients. This study was posted on clinicaltrials.gov on 7/25/2021 and was last updated on 2/2/2022."
Answered by AI
Who else is applying?
What portion of applicants met pre-screening criteria?
Did not meet criteria
How many prior treatments have patients received?
3+
Why did patients apply to this trial?
You propose a digital treatment and not a drugs one.
PatientReceived 2+ prior treatments
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