ADEPT: Addressing Disability Effectively With Psychosocial Telemedicine

• Sponsor: University of Pennsylvania (Other)
• Overall Status: Not yet recruiting
• CT.gov ID: NCT05635292
• Collaborator: Crohn's and Colitis Foundation (Other)
• Enrollment: 420
• Arms: 2
• Anticipated Duration (Months): 12

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Crohn Disease	Behavioral: Tele-CBT	N/A

Study Design

• Study Type: Interventional
• Anticipated Enrollment: 420 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: None (Open Label)
• Primary Purpose: Other
• Official Title: Addressing Disability Effectively With Psychosocial Telemedicine (ADEPT Study): An Open-label, Multicenter Pragmatic Randomized Control Trial
• Anticipated Study Start Date: Jan 1, 2023
• Anticipated Primary Completion Date: Jan 1, 2024
• Anticipated Study Completion Date: Jan 1, 2024

Arms and Interventions

Arm	Intervention/Treatment
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)
No Intervention: Control

Outcome Measures

Primary Outcome Measures

1. Change in the IBD Disability Index [8 weeks]

   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).

Secondary Outcome Measures

1. Cost-benefits of telemedicine-delivered psychosocial care [8 weeks]

   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.

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years and Older
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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

Contacts and Locations

Locations

No locations specified.

Sponsors and Collaborators

• University of Pennsylvania
• Crohn's and Colitis Foundation

Investigators

• Principal Investigator: Chung Sang Tse, University of Pennsylvania

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: University of Pennsylvania
• ClinicalTrials.gov Identifier: NCT05635292
• Other Study ID Numbers: 851901
• First Posted: Dec 2, 2022
• Last Update Posted: Dec 16, 2022
• Last Verified: Dec 1, 2022

• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No
• Additional relevant MeSH terms: Crohn Disease

Study Results

No Results Posted as of Dec 16, 2022