NCT05413941|Withdrawn

Study Stopped

No participants were enrolled into this study. Study Start Date previously entered was for Aim 1 of the protocol and unrelated to this registration (see 'Detailed Description'). Primary Completion and Study Completion Dates reflect IRB closeout date.

Internet-based Cognitive Behavioral Therapy in Inflammatory Bowel Disease

Montefiore Medical Center ClinicalTrials.gov

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2 other identifiers

2022-14155K12TR004411

Study Type

interventional

Target

N/A

Locations

0 countries

Sites

N/A

Timeline

RegisteredJun 2022

StartedSep 2022

CompletionJun 2025

Brief Summary

While people of color are an increasing segment of the inflammatory bowel disease (IBD) population, they are currently underrepresented in research, including studies of psychological distress. Appreciation for psychological distress (anxiety, depression, perceived stress) as a driver of IBD activity has led to increased efforts to integrate psychological interventions into IBD medical care. Cognitive behavioral therapy (CBT) is the most studied psychotherapeutic approach in IBD and the one that suggests improvements in mental health and quality of life in those with elevated psychological distress. There are unanswered questions in the use of CBT in IBD: how to leverage digital technology to deliver CBT through internet-based cognitive behavioral therapy (iCBT); how do we consider the social context of individuals from racial and ethnic minority groups who may experience distinct social and structural barriers to acceptance and use of psychological interventions? Thus, this study will qualitatively analyze how factors, such as digital access, mental health stigma, and lived experience with IBD and as racial or ethnic minority influence attitudes toward mental health and iCBT in a cohort of Black and Latino IBD patients with elevated psychological distress. Results will lead to adaptation of a CBT program into an iCBT app to be tested for acceptance/use and to explore effects on psychological and disease-related factors.

Trial Health

At Risk

Trial Health Score

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

Trial has exceeded expected completion date

Timeline

Completed

Started Sep 2022

Typical duration for not_applicable

Status

withdrawn

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

Trial Relationships

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Study Timeline

Key milestones and dates

2.8 years study duration

First Submitted

Initial submission to the registry

June 7, 2022

Completed

3 days until next milestone

First Posted

Study publicly available on registry

June 10, 2022

Completed

4 months until next milestone

Study Start

First participant enrolled

September 26, 2022

Completed

2.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 30, 2025

Completed

Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 30, 2025

Completed

Last Updated

August 13, 2025

Status Verified

August 1, 2025

Enrollment Period

2.8 years

First QC Date

June 7, 2022

Last Update Submit

August 7, 2025

Conditions

Inflammatory Bowel Diseases Psychological Distress

Outcome Measures

Primary Outcomes (2)

Recruitment Rate
Proportion of eligible patients who enroll into the trial
8 weeks
Adherence Rate
Number of activities and weekly sessions completed
8 weeks

Secondary Outcomes (7)

Illness Perception
8 weeks
Self-efficacy
8 weeks
Coping
8 weeks
Crohn's Activity
8 weeks
Ulcerative Colitis Activity
8 weeks
+2 more secondary outcomes

Study Arms (1)