Eligibility Module

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: 2025-12-24 @ 3:07 PM
Ignite Modification Date: 2025-12-24 @ 3:07 PM
NCT ID: NCT05635292
Eligibility Criteria: Inclusion Criteria: 1. Adults ≥18 years old with a diagnosis of Crohn's disease (CD) or ulcerative colitis (UC) 2. Willingness to complete the baseline survey online. Participants in Aim 1 with moderate-to-severe disability based on the IBD Disability Index (IBD-DI) will be invited to the Aim 2 clinical trial 3. Able to consent and complete surveys in English. Exclusion Criteria: 1. no/low disability (IBD-DI \<35) on the baseline survey 2. inability or unwillingness to participate in telemedicine with a therapist 3. Have an existing relationship with a mental health specialist within the past 3 months 4. Lack of access to a computer, working internet connection, and a private environment to complete teletherapy sessions if they are randomized to this intervention
Healthy Volunteers: False
Sex: ALL
Minimum Age: 18 Years
Study: NCT05635292
Study Brief:
Protocol Section: NCT05635292