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 @ 3:44 AM
Ignite Modification Date:
2025-12-25 @ 3:44 AM
NCT ID:
NCT05524402
Eligibility Criteria:
Inclusion Criteria:
* Male and female outpatients, ages 18-35
* English fluency and literacy
* Diagnosed with a concussion in the past 10 weeks
* Owns a smartphone or computer with Internet access
* Willingness and ability to participate in four 45-minute program sessions and answer remote questionnaires before, after, and 3-month following the program
* Free of concurrent psychotropic or have been on stable dosage for at least 6 weeks
* Clinically significant anxiety symptoms (score ≥ 5 on GAD-7 anxiety scale)
Exclusion Criteria:
* Previous history of moderate or severe TBI OR concussion in the past 2 years that resulted in symptoms lasting 3 months or more
* Diagnosed with a medical illness expected to worsen in the next 6 months (e.g., malignancy)
* Lifetime history of schizophrenia, bipolar disorder, or other psychotic disorder
* Current substance abuse or dependence and current substance use disorder
* Current active self-reported suicidal ideation
* Practice of mindfulness techniques for greater than 45 minutes per week within the last 3 months
* Participation in a mind-body or CBT treatment in the past 3 months
* Currently pregnant
Healthy Volunteers:
True
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
35 Years
Study:
NCT05524402
Study Brief:
Protocol Section:
NCT05524402