N/A
Completed N=40
Evaluating Mindfulness-Based Interventions With New Fibromyalgia Patients
Source: ClinicalTrials.gov NCT04720053 ↗Enrolled (actual)
40
Serious AEs
0.0%
Results posted
Sep 2024
Primary outcomePrimary: Change in Widespread Pain Index (WPI) — 1.4 units on a scale
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.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Change in Widespread Pain Index (WPI) |
1.4 | — |
| PRIMARY Change in Perceived Stress Scale |
4.1 | — |
Eligibility Criteria
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.
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.
Data sourced from ClinicalTrials.gov (NCT04720053). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.