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 @ 12:26 AM
Ignite Modification Date:
2025-12-25 @ 12:26 AM
NCT ID:
NCT06537258
Eligibility Criteria:
Inclusion Criteria:
* Diagnosis with biopsy-confirmed IBD for at least 4 months,
* ages 13 through 18 years inclusive,
* speak English,
* enrolling with at least 1 parent/guardian who is willing to participate by completing surveys,
* positive depression or anxiety screens using the PHQ-4, - access to home internet to participate in virtual intervention,
* youth and parent agree to the conditions of study participation, including randomization, participation in intervention, and follow-up assessments,
* youth is medically approved to engage in normal daily activities (e.g., attend school, extracurricular activities)
Exclusion Criteria:
* previous diagnosis of developmental disabilities that require full-time special education or that impair the ability to respond to treatment,
* diagnosis with any other chronic disease (e.g., diabetes, epilepsy, etc.),
* diagnosis of abnormal thyroid function,
* treatment with any drug with known autonomic cardiovascular influences including beta-blockers, central sympatholytic agents, or antidepressants.
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
13 Years
Maximum Age:
18 Years
Study:
NCT06537258
Study Brief:
Protocol Section:
NCT06537258