Addressing Disability Effectively With Psychosocial Telemedicine (ADEPT)

University of Pennsylvania

Status: Completed

Conditions: Crohn Disease

Treatments: Behavioral: Tele-CBT

Study type: Interventional

Funder types: Other

Identifiers

NCT05635292

851901

Details and patient eligibility

About

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.

Enrollment: 715 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Other

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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715 participants in 2 patient groups

Tele-CBT

Experimental group

Treatment:

Behavioral: Tele-CBT

Control

No Intervention group