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Clinical Trials/NCT05433337
NCT05433337CompletedNot Applicable

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

Swing Therapeutics, Inc.1 site in 1 country60 target enrollmentStarted: June 8, 2022Last updated:
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Conditions
Interventions

Trial Snapshot

Phase
Not Applicable
Status
Completed
Enrollment
60
Locations
1
Primary Endpoint
Patient Global Impression of Change (PGIC)
Study OverviewStudy DesignEligibility CriteriaArms & InterventionsOutcomesInvestigatorsSitesRecords & IdentifiersSimilar Trials

Study Overview

Brief Summary

This study is designed as a 9-month extension of the original study (PROSPER-FM). The purpose of the extension study is to assess the long-term (up to 1 year) response to a digital therapy in the treatment of fibromyalgia.

Study Design

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

Eligibility Criteria

Ages
22 Years to 75 Years (Adult, Older Adult)
Sex
All
Accepts Healthy Volunteers
No

Inclusion Criteria

  • •Participant has completed participation in the PROSPER-FM study and was assigned to the Digital ACT Arm
  • •Participant is willing and able to comply with all protocol-specified requirements

Exclusion Criteria

  • •Based on the investigator's judgment, any new diagnosis of acute or chronic disease/condition since participant's enrollment in PROSPER-FM study that may impact the outcome of this study
  • •Severe depression at the final visit of the PROSPER-FM study (measured by BDI-II)
  • •Increased risk of suicide on the basis of the investigator's judgment or the Columbia-Suicide Severity Rating Scale ("C-SSRS") at the final visit of the PROSPER-FM study

Arms & Interventions

Digital Acceptance and Commitment Therapy (ACT) Arm

Other

Intervention: Digital ACT (Device)

Outcomes

Primary Outcomes

Patient Global Impression of Change (PGIC)

Time Frame: Month 9

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(Original Study Baseline to Month 9)

Investigators

Sponsor Class
Other
Responsible Party
Sponsor

Study Sites (1)

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