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Completed

NCT Number: NCT05149222

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

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.

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Key information

Conditions

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

Age range

22 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Swing Therapeutics

San Francisco, California, 94111, United States

Who can participate

Healthy volunteers accepted: No

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

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

  • None

Treatment and study plan

Digital ACT

Device

This is a virtual, single-arm, non-significant risk study. Study participants will receive 9 months of Digital Acceptance and Commitment Therapy (ACT) in addition to their standard care for fibromyalgia.

Primary outcomes

  1. 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

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

    Time frame: Enrollment to Month 9

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

  2. Revised Fibromyalgia Impact Questionnaire (FIQ-R) symptoms domain score

    Time frame: Enrollment to Month 9

    FIQ-R symptoms domain score ranges between 0-50 with a reduction in score indicating reduced fibromyalgia symptoms.

  3. Revised Fibromyalgia Impact Questionnaire (FIQ-R) function domain score

    Time frame: Enrollment to Month 9

    FIQ-R function domain score ranges between 0-30 with a reduction in score indicating improved function.

  4. Revised Fibromyalgia Impact Questionnaire (FIQ-R) impact domain score

    Time frame: Enrollment to Month 9

    FIQ-R impact domain score ranges between 0-20 with a reduction in score indicating reduced fibromyalgia impact.

  5. Participant's self-reported average weekly pain score, recorded on an NRS scale

    Time frame: Enrollment to Month 9

    Average pain intensity score ranges between 0-10 with a reduction in score indicating a decrease in pain intensity.

  6. Participant's self-reported average weekly pain interference score, recorded on an NRS

    Time frame: Enrollment to Month 9

    Average pain interference score ranges between 0-10 with a reduction in score indicating a decrease in pain interference.

  7. Participant's self-reported weekly sleep interference score, recorded on an NRS scale

    Time frame: Enrollment to Month 9

    Average sleep interference score ranges between 0-10 with a reduction in score indicating a decrease in sleep interference.

Sponsors and collaborators

Lead sponsor

Swing Therapeutics, Inc.

Other

Registry information

Important dates

Study start
2021
Primary completion
2024
Study completion
2024
First posted
Dec 8, 2021
Registry last updated
Jul 16, 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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