NCT05635292

Brief 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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
715

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Feb 2023

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

November 10, 2022

Completed
22 days until next milestone

First Posted

Study publicly available on registry

December 2, 2022

Completed
3 months until next milestone

Study Start

First participant enrolled

February 15, 2023

Completed
12 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 31, 2024

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

January 31, 2024

Completed
Last Updated

October 2, 2024

Status Verified

September 1, 2024

Enrollment Period

12 months

First QC Date

November 10, 2022

Last Update Submit

September 30, 2024

Conditions

Crohn Disease

Outcome Measures

Primary Outcomes (1)

  • Change in the IBD Disability Index

    Change in the IBD Disability is estimated by the 14-item validated IBD Disability Index (IBD-DI) in the intervention group (telemedicine-delivered psychosocial care) vs control group (usual care) in patients with moderate-to-severe baseline IBD-related disability pre and post intervention (week 0 and week 8). Total score ranges from 0-100, interpreted as 0-20 (no disability), 20-35 (mild disability), 35-50 (moderate disability), and 50-100 (severe disability).

    8 weeks

Secondary Outcomes (1)

  • Cost-benefits of telemedicine-delivered psychosocial care

    8 weeks

Study Arms (2)

Tele-CBT

EXPERIMENTAL
Behavioral: Tele-CBT

Control

NO INTERVENTION

Interventions

Tele-CBTBEHAVIORAL

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)

Tele-CBT

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of Pennsylvania

Philadelphia, Pennsylvania, 19104, United States

Location

Related Publications (4)

  • 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.

    PMID: 37603844BACKGROUND

  • 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.

    PMID: 40736700DERIVED

  • 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.

    PMID: 40243391DERIVED

  • 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.

    PMID: 39919362DERIVED

MeSH Terms

Conditions

Crohn Disease

Condition Hierarchy (Ancestors)

Inflammatory Bowel DiseasesGastroenteritisGastrointestinal DiseasesDigestive System DiseasesIntestinal Diseases

Study Officials

  • Chung Sang Tse

    University of Pennsylvania

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
OTHER
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

November 10, 2022

First Posted

December 2, 2022

Study Start

February 15, 2023

Primary Completion

January 31, 2024

Study Completion

January 31, 2024

Last Updated

October 2, 2024

Record last verified: 2024-09

Locations

US(1)