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Completed

NCT Number: NCT05433337

Prospective Study to Evaluate a Digital Regimen for Fibromyalgia Management: An Extension Study

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.

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Key information

Conditions

Fibromyalgia Muscular Diseases Musculoskeletal Diseases Nervous System Diseases Neuromuscular Diseases Rheumatic Diseases

Age range

22 year–75 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Swing Therapeutics

San Francisco, California, 94104, United States

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Key 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

Key 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

Treatment and study plan

Digital ACT

Device

Study participants will continue to receive Digital Acceptance and Commitment Therapy in addition to their standard care for fibromyalgia

Primary outcomes

  1. 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

  1. Revised Fibromyalgia Impact Questionnaire (FIQ-R) total score

    Time frame: Original Study Baseline to Month 9

    FIQ-R total score ranges between 0-100 with a reduction in score indicating reduced fibromyalgia severity.

Sponsors and collaborators

Lead sponsor

Swing Therapeutics, Inc.

Other

Registry information

Official study title

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

Acronym: PROSPER-FM-EXT

Important dates

Study start
2022
Primary completion
2024
Study completion
2024
First posted
Jun 27, 2022
Registry last updated
Jun 27, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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