NCT05635292Completed
Addressing Disability Effectively With Psychosocial Telemedicine
Addressing Disability Effectively With Psychosocial Telemedicine (ADEPT Study): An Open-label, Multicenter Pragmatic Randomized Control Trial
Source: ClinicalTrials.gov · Last updated 23 Oct 2026
Brief summary (registry, in English)
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.
- Status (registry)
- Completed
- Study type
- Interventional
- Enrollment
- 715 (actual)
- First submitted
- 10 Nov 2022
- Start date
- 15 Feb 2023
- Primary completion date
- 31 Jan 2024
- Lead sponsor
- University of Pennsylvania
- Diseases
- Crohn's disease
- NCT number
- NCT05635292
What you commit to
- Study type: Interventional
- Participants enrolled: 715
- From 15 Feb 2023 to the primary completion date, 31 Jan 2024
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Other
- no/low disability (IBD-DI \<35) on the baseline survey
- inability or unwillingness to participate in telemedicine with a therapist
- Have an existing relationship with a mental health specialist within the past 3 months
- Lack of access to a computer, working internet connection, and a private environment to complete teletherapy sessions if they are randomized to this intervention
Who the study is looking for
- 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 trial
- Able to consent and complete surveys in English.
Age in the registry: 18 years to - · Sex: All · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| University of Pennsylvania Coordinator of this site? Confirm its status | Philadelphia | United States | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.