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Completed

NCT Number: NCT05011162

"REACT-FM" Real-World Evidence From Smartphone-Based Acceptance and Commitment Therapy in Fibromyalgia

The objective of this study is to assess the clinical impact of a digital therapy for the management of fibromyalgia. Study participants receive 12 weeks of Digital Acceptance and Commitment Therapy (ACT) in addition to their standard care for fibromyalgia. The primary endpoint is the Patient Global Impression of Change (PGIC) at week 12. This is a virtual, single-arm, pragmatic, non-significant risk study.

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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.

Key Inclusion Criteria:

  • Participant is 22 years of age or older
  • Participant has a diagnosis of fibromyalgia based on self-reported responses to 2016 ACR criteria for fibromyalgia diagnosis
  • Participant is capable of reading and understanding English and has provided written informed consent to participate (signed electronically).

Key Exclusion Criteria:

  • Participant is not a resident of the United States
  • In the opinion of the Investigator or Sponsor, the participant suffers from a severe psychiatric condition
  • Participant has a diagnosis of, or is being treated for any type of Dementia (Parkinson's disease, Alzheimer's Disease, Huntington's Disease, Lewy Body Dementia, Creuztfeldt-Jacob Disease, Frontotemporal Dementia, Korsakoff Syndrome, Vascular Dementia) or a current diagnosis of cancer or recurrence in the past 3 years (other than basal or squamous cell skin cancer)

Treatment and study plan

Digital ACT

Device

Study participants will receive 12 weeks of Digital Acceptance and Commitment Therapy (ACT).

Primary outcomes

  1. Patient Global Impression of Change (PGIC) Response

    Time frame: Week 12

    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: Baseline to Week 12

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

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

    Time frame: Baseline to Week 12

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

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

    Time frame: Baseline to Week 12

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

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

    Time frame: Baseline to Week 12

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

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

    Time frame: Baseline to Week 12

    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 scale

    Time frame: Baseline to Week 12

    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: Baseline to Week 12

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

  8. Participant's engagement with the Digital ACT device

    Time frame: Weeks 1-12

    Participant engagement will be assessed by evaluating the following:

    Average days engaged in treatment per week (number of days opening the device), with a higher score indicating more engagement.

  9. Participant's engagement with the Digital ACT device

    Time frame: Weeks 1-12

    Participant engagement will be assessed by evaluating the following:

    Average number of completed sessions per week, with a higher score indicating more engagement.

  10. Participant's compliance with the Digital ACT device

    Time frame: Weeks 1-12

    Participant compliance will be assessed by evaluating the percentage of participants who completed the core program within the study time frame.

Sponsors and collaborators

Lead sponsor

Swing Therapeutics, Inc.

Other

Registry information

Acronym: REACT-FM

Important dates

Study start
2021
Primary completion
2024
Study completion
2024
First posted
Aug 18, 2021
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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