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Clinical Trials/NCT05149222
NCT05149222CompletedNot Applicable

"REACT-FM-EXT": Real-World Evidence From Smartphone-Based Acceptance and Commitment Therapy in Fibromyalgia: An Extension Study

Swing Therapeutics, Inc.1 site in 1 country50 target enrollmentStarted: November 30, 2021Last updated:
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Conditions
Interventions

Trial Snapshot

Phase
Not Applicable
Status
Completed
Enrollment
50
Locations
1
Primary Endpoint
The primary efficacy endpoint is the response rate to Patient Global Impression of Change (PGIC).
Study OverviewStudy DesignEligibility CriteriaArms & InterventionsOutcomesInvestigatorsSitesRecords & IdentifiersSimilar Trials

Study Overview

Brief Summary

This is an extension study of REACT-FM. The primary objective of the study is to assess the response to digital therapy in the treatment of fibromyalgia over an additional 9 months.

Study Design

Study Type
Interventional
Allocation
Na
Intervention Model
Single Group
Primary Purpose
Treatment
Masking
None

Eligibility Criteria

Ages
22 Years to — (Adult, Older Adult)
Sex
All
Accepts Healthy Volunteers
No

Inclusion Criteria

  • •Participant has completed participation in the REACT-FM study.
  • •Participant has completed 41 sessions within Tempo in the REACT-FM study and is willing and able to comply with all protocol-specified requirements.
  • •Participant has provided informed consent to participate.
  • •Participant continues to meet original safety criteria for the REACT-FM study.

Exclusion Criteria

  • Not provided

Arms & Interventions

Digital Acceptance and Commitment Therapy (ACT) Arm

Other

Pragmatic

Intervention: Digital ACT (Device)

Outcomes

Primary Outcomes

The primary efficacy endpoint is the response rate to Patient Global Impression of Change (PGIC).

Time Frame: 9 months

PGIC scores included are: Very much improved, much improved, minimally improved, no change, minimally worse, much worse, very much worse

Secondary Outcomes

  • Revised Fibromyalgia Impact Questionnaire (FIQ-R) total score(Enrollment to Month 9)
  • Participant's self-reported weekly sleep interference score, recorded on an NRS scale(Enrollment to Month 9)
  • Participant's self-reported average weekly pain interference score, recorded on an NRS(Enrollment to Month 9)
  • Participant's self-reported average weekly pain score, recorded on an NRS scale(Enrollment to Month 9)
  • Revised Fibromyalgia Impact Questionnaire (FIQ-R) symptoms domain score(Enrollment to Month 9)
  • Revised Fibromyalgia Impact Questionnaire (FIQ-R) function domain score(Enrollment to Month 9)
  • Revised Fibromyalgia Impact Questionnaire (FIQ-R) impact domain score(Enrollment to Month 9)

Investigators

Sponsor Class
Other
Responsible Party
Sponsor

Study Sites (1)

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