← Back to all trials
Not Yet Recruiting
NCT05635292
Addressing Disability Effectively With Psychosocial Telemedicine
Conditions: Crohn Disease
Sex: All
Ages: 18 Years – N/A
Phase: NA
Enrollment: 420
Sponsor: University of Pennsylvania
Summary
This multi-site study will be implemented at 5 gastroenterology practices to recruit 420 adults with IBD to complete a baseline survey and enroll those with higher scores on a validated IBD-disability scale into a randomized controlled trial of telehealth-delivered cognitive behavioral therapy with a licensed psychologist versus usual care.
The investigators aim to lay the foundations that will shift the paradigm of IBD clinical practice towards a new horizon of holistic and equitable high-value care.
Eligibility Criteria
Inclusion Criteria:Adults ≥18 years old with a diagnosis of Crohn's disease (CD) or ulcerative colitis (UC)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 trialAble to consent and complete surveys in English.Exclusion Criteria:no/low disability (IBD-DI <35) on the baseline surveyinability or unwillingness to participate in telemedicine with a therapistHave an existing relationship with a mental health specialist within the past 3 monthsLack of access to a computer, working internet connection, and a private environment to complete teletherapy sessions if they are randomized to this intervention
Source: ClinicalTrials.gov (NCT05635292). StuddyBuddy aggregates publicly available trial information.