Addressing Disability Effectively With Psychosocial Telemedicine

Study Purpose

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.

Recruitment Criteria

Accepts Healthy Volunteers

Healthy volunteers are participants who do not have a disease or condition, or related conditions or symptoms

Study Type

An interventional clinical study is where participants are assigned to receive one or more interventions (or no intervention) so that researchers can evaluate the effects of the interventions on biomedical or health-related outcomes.

An observational clinical study is where participants identified as belonging to study groups are assessed for biomedical or health outcomes.

Searching Both is inclusive of interventional and observational studies.

Eligible Ages 18 Years and Over
Gender All
More Inclusion & Exclusion 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

Trial Details

Trial ID:

This trial id was obtained from, a service of the U.S. National Institutes of Health, providing information on publicly and privately supported clinical studies of human participants with locations in all 50 States and in 196 countries.


Phase 1: Studies that emphasize safety and how the drug is metabolized and excreted in humans.

Phase 2: Studies that gather preliminary data on effectiveness (whether the drug works in people who have a certain disease or condition) and additional safety data.

Phase 3: Studies that gather more information about safety and effectiveness by studying different populations and different dosages and by using the drug in combination with other drugs.

Phase 4: Studies occurring after FDA has approved a drug for marketing, efficacy, or optimal use.

Lead Sponsor

The sponsor is the organization or person who oversees the clinical study and is responsible for analyzing the study data.

University of Pennsylvania
Principal Investigator

The person who is responsible for the scientific and technical direction of the entire clinical study.

Chung Sang Tse
Principal Investigator Affiliation University of Pennsylvania
Agency Class

Category of organization(s) involved as sponsor (and collaborator) supporting the trial.

Overall Status Recruiting
Countries United States

The disease, disorder, syndrome, illness, or injury that is being studied.

Crohn Disease
Arms & Interventions


Experimental: Tele-CBT

No Intervention: Control


Behavioral: - Tele-CBT

8 weekly 1-hr telemedicine visits with a licensed Ph.D. psychologist from the University of Pennsylvania (permissible to practice across state lines under PSYPACT), plus usual care and referral to an IBD Help Center (email, phone, online chat with IBD information specialist)

Contact a Trial Team

If you are interested in learning more about this trial, find the trial site nearest to your location and contact the site coordinator via email or phone. We also strongly recommend that you consult with your healthcare provider about the trials that may interest you and refer to our terms of service below.

University of Pennsylvania, Philadelphia, Pennsylvania




University of Pennsylvania

Philadelphia, Pennsylvania, 19104

Site Contact

Chung Sang Tse, MD