Evaluating Mindfulness-Based Interventions With New Fibromyalgia Patients

Not Applicable

Completed

• Conditions: Fibromyalgia
• Interventions: Device: Wearable brain sensing wellness device headband system

• Registration Number: NCT04720053
• Lead Sponsor: Mayo Clinic

Brief Summary

The purpose of this study is to study the feasibility of a wearable brain sensing wellness device to provide mindfulness training to fibromyalgia patients who have failed medical therapy.

Detailed Description

All study participants will receive a wearable brain sensing wellness device, and demonstration of the mindfulness sessions. Participants will be asked to complete study surveys/questionnaires. During the first part of study, participants will be asked to complete the intervention. After completion of the intervention they will enter a follow-Up Phase, where they will be contacted and asked to complete surveys and gauge satisfaction with the study.

Study Timeline

• Study First Submitted: 2021-01-19
• Study First Submitted QC: 2021-01-19
• Study First Posted: 2021-01-22
• Study Start: 2021-11-01
• Primary Completion: 2023-07-28
• Study Completion: 2023-07-28
• Status Verified: 2023-10
• Last Update Submitted: 2023-10-13
• Last Update Posted: 2023-10-16

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 44

Inclusion Criteria

• 18 years of age or older at time of consent.
• Diagnosed with Fibromyalgia.
• Not pregnant by subject self-report at time of consent.
• Have the ability to provide informed consent.
• Have the ability to complete all aspects of this trial.
• Have access to a iPhone, iPad, Android device.
• Has no contraindicating comorbid health condition as determined by the clinical investigators.

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Exclusion Criteria

• Used or been enrolled in any treatments for fibromyalgia, or pain within the past 30 days.
• Used an investigational drug within the past 30 days.
• Currently (within the past 3 weeks) been practicing mindfulness training on a weekly/regular basis.
• Currently (within the past 3 weeks) been undergoing an additional program (e.g. CAM) to improve quality of life.
• Currently (within 3 weeks) been enrolled in another clinical or research program (e.g. CAM) which intervenes on the patients' QOL, or stress.
• An unstable medical or mental health condition as determined by the physician investigator.

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Wearable brain sensing wellness device headband system	Wearable brain sensing wellness device headband system	Subject diagnosed with fibromyalgia at Mayo Clinic GIM Fibromyalgia Clinic will receive a wearable brain sensing wellness device headband system, and will be given a demonstration of the mindfulness sessions, with detailed instructions on how to begin each session.

Primary Outcome Measures

Name	Time	Method
Change in Widespread Pain Index (WPI)	Baseline to end of treatment (day 90)	Wide pain index (WPI) defined as a 4-quadrant plus axial pain, measuring widespread pain in 19 body areas where the patient feels pain over the prior week. Each area identified on the list counts as 1. The range on the WPI score can range from 0 to 19. With lower number indicating fewer areas of pain (hence lower pain). The difference is calculated by taking the baseline score minus the end of treatment score.
Change in Perceived Stress Scale	Baseline to end of treatment (day 90)	Measured on a 0-10 pain assessment scale. Participants rate their stress on a scale of 0 to 10. Zero means "no stress," and 10 means "the worst possible stress". The difference is calculated by taking the baseline score minus the end of treatment score.

Trial Locations

Locations (1)

Mayo Clinic in Rochester; 🇺🇸 Rochester, Minnesota, United States