Prospective Study to Evaluate a Digital Regimen for Fibromyalgia Management

Exclusion Criteria

• •1. Lifetime history of bipolar or other psychotic disorder
• •2. Severe depression at screening (measured by BDI-II)
• •3. The participant is at increased risk of suicide on the basis of the investigator's judgment or the Columbia-Suicide Severity Rating Scale ("C-SSRS")
• •4. Participant has any other disease or medical condition that, in the opinion of the Investigator or Sponsor, could endanger the participant, interfere with the evaluation of the study device's efficacy or safety, or compromise the participant's ability to comply with/complete the study.