Addressing Disability Effectively With Psychosocial Telemedicine (ADEPT)

Addressing Disability Effectively With Psychosocial Telemedicine (ADEPT Study): An Open-label, Multicenter Pragmatic Randomized Control Trial

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.

Study Overview

• Status: Completed
• Conditions: Crohn Disease
• Intervention / Treatment: Behavioral: Tele-CBT

• Study Type: Interventional
• Enrollment (Actual): 715
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Pennsylvania
    • Philadelphia, Pennsylvania, United States, 19104
      • University of Pennsylvania

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Other
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
No Intervention: Control
Experimental: Tele-CBT	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)

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Cost-benefits of telemedicine-delivered psychosocial care	The cost-benefits of tele-CBT are estimated by 5-item validated Centers for Medicare & Medicaid Services (CMS)-certified FAIR Health database questionnaire titled the Treatment Inventory of Costs in Patients (TIC-P). The minimum value is $0, with no maximum value. Higher costs indicate worse outcome. In order to calculate the costs of productivity losses, the healthcare utilization encounter are multiplied by the cost price per unit. The cost of unpaid productivity loss is calculated by multiplying the productivity losses by a standard hourly rate for household care.	8 weeks

Collaborators and Investigators

• Sponsor: University of Pennsylvania
• Collaborators: Crohn's and Colitis Foundation
• Investigators: Principal Investigator: Chung Sang Tse, University of Pennsylvania

Publications and helpful links

General Publications

• 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.

Helpful Links

• Inflammatory Bowel Diseases-related Disability: Risk Factors, Outcomes, and Interventions, Inflammatory Bowel Diseases

Study record dates

Study Major Dates

• Study Start (Actual): February 15, 2023
• Primary Completion (Actual): January 31, 2024
• Study Completion (Actual): January 31, 2024

Study Registration Dates

• First Submitted: November 10, 2022
• First Submitted That Met QC Criteria: November 22, 2022
• First Posted (Actual): December 2, 2022

Study Record Updates

• Last Update Posted (Actual): October 2, 2024
• Last Update Submitted That Met QC Criteria: September 30, 2024
• Last Verified: September 1, 2024

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Digestive System Diseases; Gastrointestinal Diseases; Gastroenteritis; Intestinal Diseases; Inflammatory Bowel Diseases; Crohn Disease
• Other Study ID Numbers: 851901

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No