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Addressing Disability Effectively With Psychosocial Telemedicine

NCT05635292 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 715

Last updated 2024-10-02

No results posted yet for this study

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.

Conditions

  • Crohn Disease

Interventions

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)

Sponsors & Collaborators

Principal Investigators

  • Chung Sang Tse · University of Pennsylvania

Study Design

Allocation
RANDOMIZED
Purpose
OTHER
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2023-02-15
Primary Completion
2024-01-31
Completion
2024-01-31

Countries

  • United States

Study Locations

More Related Trials

Entities

Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05635292 on ClinicalTrials.gov