Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-25 @ 2:24 AM
Ignite Modification Date:
2025-12-25 @ 2:24 AM
NCT ID:
NCT07090434
Eligibility Criteria:
Inclusion Criteria:
* Participants will be adults between 18 and 65 years of age with a clinical diagnosis of fibromyalgia according to the 2016 criteria established by the American College of Rheumatology (ACR).
* All participants must be actively enrolled in the group sessions offered by the patient association and possess the ability to use a smartphone or tablet compatible with the BEI app.
* Informed consent must be provided voluntarily.
* Additionally, participants are required to have a minimum level of digital health literacy, operationalized as a score equal to or greater than 2.5 in at least four dimensions of the eHealth Literacy Questionnaire (eHLQ).
Exclusion Criteria:
* Participants will be excluded if they present with severe or unstable psychiatric disorders, such as schizophrenia or uncontrolled major depression.
* Other exclusion criteria include medical comorbidities that contraindicate physical activity, current pregnancy, or concurrent participation in another digital health program or the use of similar therapeutic applications.
* Individuals with cognitive impairments or technological limitations that prevent the use of the app or participation in digital assessments will also be excluded.
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
65 Years
Study:
NCT07090434
Study Brief:
Protocol Section:
NCT07090434