Crohn DiseaseADEPTNCT05635292
Addressing Disability Effectively With Psychosocial Telemedicine
A study testing Tele-CBT in people with Crohn Disease, run by University of Pennsylvania at 1 site in United States.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Crohn Disease
- What is being tested?
- Tele-CBT
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 715 participants
- Where
- 1 siteUnited States
- Study dates
- 15 Feb 2023to 31 Jan 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
United States1 site
University of Pennsylvania
Philadelphia, Pennsylvania, 19104
About this study
Official title: 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.
- Conditions
- Crohn Disease
- Being tested
- Tele-CBT
- Medical subject headings
- Crohn Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Tele-CBTBehavioural
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)
| Study group | Role | What they receive |
|---|---|---|
| Tele-CBT | Experimental | Not described Receives: Behavioral: Tele-CBT |
| Control | No intervention | Not described |
What is being measured
The primary outcome is the main question the study is designed to answer.
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).
Measured: 8 weeks
Secondary outcomes (1)
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.
Measured: 8 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Dec 2022
- Study start15 Feb 2023
- Primary completion31 Jan 2024
- Study completion31 Jan 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Crohn DiseaseStudies of the same condition, open and under way.
- More trials run by University of PennsylvaniaThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 715 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Pennsylvania
- Sponsor type
- University, hospital or other
- Collaborators
- Crohn's and Colitis Foundation
- Responsible party
- Sponsor
- Investigators
- Chung Sang Tse, Principal investigator, University of Pennsylvania
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05635292
- Sponsor's protocol ID
- 851901
- Acronym
- ADEPT
- Status last verified
- Oct 2026
- First submitted
- 10 Nov 2022
- Last updated
- 23 Oct 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
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. 2026 Jun 1;121(6):1435-1444. doi: 10.14309/ajg.0000000000003681. Epub 2025 Jul 30.
PubMed 40736700Tiles-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.
PubMed 40243391Hunt 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.
PubMed 39919362
Study at a glance
From the registry record, last updated by the sponsor on 23 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Addressing Disability Effectively With Psychosocial Telemedicine (ADEPT Study): An Open-label, Multicenter Pragmatic Randomized Control Trial
- ClinicalTrials.gov ID
- NCT05635292
- Acronym / sponsor ID
- ADEPT / 851901
- Conditions
- Crohn Disease
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 715 participants (actual)
- Lead sponsor
- University of PennsylvaniaUniversity, hospital or other
- Collaborators
- Crohn's and Colitis Foundation
- Study start
- 15 Feb 2023 (actual)
- Primary completion
- 31 Jan 2024 (actual)
- Study completion
- 31 Jan 2024 (actual)
- First posted
- 2 Dec 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Tele-CBT | Experimental | Behavioral: Tele-CBT |
| Control | No intervention | – |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- 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.
Key exclusion criteria (4 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Tele-CBT8 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) | Behavioural | Tele-CBT |
Primary outcome
Change in the IBD Disability Index
Time frame: 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).
1 secondary outcome
Cost-benefits of telemedicine-delivered psychosocial care
Time frame: 8 weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Oct 2026.
- Derived from this study: PubMed 40736700Tse 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. 2026 Jun 1;121(6):1435-1444. doi: 10.14309/ajg.0000000000003681. Epub 2025 Jul 30.
- Derived from this study: PubMed 40243391Tiles-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.
- Derived from this study: PubMed 39919362Hunt 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Chung Sang Tse principal investigator
University of Pennsylvania
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Tele-CBT in people with Crohn Disease, run by University of Pennsylvania at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 23 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in the IBD Disability Index (time frame: 8 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05635292, which also lists 3 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 23 Oct 2026.