Addressing Disability Effectively With Psychosocial Telemedicine
NCT ID: NCT05635292
Last Updated: 2024-10-02
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.
COMPLETED
NA
715 participants
INTERVENTIONAL
2023-02-15
2024-01-31
Brief Summary
Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.
Related Clinical Trials
Explore similar clinical trials based on study characteristics and research focus.
Improving Medication Adherence in Pediatric Inflammatory Bowel Disease
NCT01536509
A Comprehensive Self-Management Intervention for Individuals With Inflammatory Bowel Disease
NCT05651542
Use of Psychologist-administered Cognitive Behavioral Therapy (CBT) or Self-administered CBT for the Treatment of Anxiety and/or Depression in Inflammatory Bowel Disease (IBD)
NCT05377840
Behavioral Therapy for Crohn's Disease
NCT06512597
A Study on the Impact of Online Positive Psychological Intervention on the Mental Health and Quality of Life of Crohn's Disease Patients
NCT06939712
Detailed Description
Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.
Conditions
See the medical conditions and disease areas that this research is targeting or investigating.
Study Design
Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.
RANDOMIZED
PARALLEL
OTHER
NONE
Study Groups
Review each arm or cohort in the study, along with the interventions and objectives associated with them.
Tele-CBT
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)
Control
No interventions assigned to this group
Interventions
Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.
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)
Eligibility Criteria
Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.
Inclusion Criteria
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
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
18 Years
ALL
No
Sponsors
Meet the organizations funding or collaborating on the study and learn about their roles.
Crohn's and Colitis Foundation
OTHER
University of Pennsylvania
OTHER
Responsible Party
Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.
Principal Investigators
Learn about the lead researchers overseeing the trial and their institutional affiliations.
Chung Sang Tse
Role: PRINCIPAL_INVESTIGATOR
University of Pennsylvania
Locations
Explore where the study is taking place and check the recruitment status at each participating site.
University of Pennsylvania
Philadelphia, Pennsylvania, United States
Countries
Review the countries where the study has at least one active or historical site.
References
Explore related publications, articles, or registry entries linked to this study.
Tse CS, Hunt MG, Brown LA, Lewis JD. Inflammatory Bowel Diseases-related Disability: Risk Factors, Outcomes, and Interventions. Inflamm Bowel Dis. 2024 Mar 1;30(3):501-507. doi: 10.1093/ibd/izad182.
Tse CS, Lewis JD, Horst SN, Saha S, Taleban S, Shah SA, Lutz M, Fiske HW, Brown LA, Kuehnel R, Bonhomme B, Weng CH, Weaver SA, Cross RK, Hunt MG; Crohn's and Colitis Foundation's Clinical Research Alliance. Inflammatory Bowel Diseases-Specific Cognitive Behavioral Therapy Delivered Through Telehealth Reduces Disability: Addressing Disability Effectively With Psychosocial Telemedicine Pragmatic Randomized Controlled Trial. Am J Gastroenterol. 2025 Jul 30. doi: 10.14309/ajg.0000000000003681. Online ahead of print.
Tiles-Sar N, Neuser J, de Sordi D, Baltes A, Preiss JC, Moser G, Timmer A. Psychological interventions for treatment of inflammatory bowel disease. Cochrane Database Syst Rev. 2025 Apr 17;4(4):CD006913. doi: 10.1002/14651858.CD006913.pub3.
Hunt M, Tse CS, Suh L, Yang E, Bui C, Davis A, Siddiqi R, Tian V. Psychotherapy process variables in implementation of CBT for inflammatory bowel disease:Therapist competence, fidelity, and patient themes. Behav Res Ther. 2025 Mar;186:104702. doi: 10.1016/j.brat.2025.104702. Epub 2025 Jan 31.
Other Identifiers
Review additional registry numbers or institutional identifiers associated with this trial.
851901
Identifier Type: -
Identifier Source: org_study_id
More Related Trials
Additional clinical trials that may be relevant based on similarity analysis.