Internet-based Cognitive Behavioral Therapy in Inflammato... | NCT05413941

Studies
Internet-based Cognitive Behavioral Therapy in Inflammatory Bowel Disease

NCT05413941

Sponsor

Montefiore Medical Center

Status

Withdrawn

Last Update Posted

Aug 13, 2025Actual

Enrollment

0Actual

Phase

Not Applicable

Conditions

Inflammatory Bowel Diseases
Psychological Distress

Interventions

Internet-based Cognitive Behavioral Therapy

Countries

Not provided

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

ID	Type	Description	Link
K12TR004411	U.S. NIH Grant/Contract		View source

Status Module

Record Verification Date

Aug 2025

Overall Recruitment Status or Expanded Access Status

Withdrawn

Last Known Status

Not provided

Delayed Posting

Not provided

Why 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.

Expanded Access Info

Start Date

Sep 26, 2022Actual

Primary Completion Date

Jun 30, 2025Actual

Completion Date

Jun 30, 2025Actual

First Submitted Date

Jun 7, 2022

First Submission Date that Met QC Criteria

Jun 7, 2022

First Posted Date

Jun 10, 2022Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Aug 7, 2025

Last Update Posted Date

Aug 13, 2025Actual

Name	Class
National Center for Advancing Translational Sciences (NCATS)	NIH

Oversight Module

Has Data Monitoring Committee (DMC)

Not provided

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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.

Detailed Description

The clinical trial component of this study (Aim 3) was never conducted. Only Aim 1, consisting of an assessment of the factors influencing acceptance and use of iCBT via semi-structured interviews, and which did not meet the definition of a clinical trial, was conducted as part of this study. The clinical trial component associated with this study, the internet-based cognitive therapy (iCBT), is being conducted as part of the "Digital Mind Body Intervention Among Black and Hispanic Patients Living With Inflammatory Bowel Disease (DMBI)," NCT06510296 (ID: 2024-16064) clinical trial.

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not Applicable

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

0Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Internet-based Cognitive Behavioral Therapy	Experimental		Behavioral: Internet-based Cognitive Behavioral Therapy

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Internet-based Cognitive Behavioral Therapy	Behavioral	Cognitive behavioral therapy (CBT) is a form of psychotherapy in which individuals are taught to identify and modify maladaptive thinking and behavior to improve their psychological status and coping skills. CBT in this trial will be delivered digitally (internet-based).

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
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

Measure	Description	Time Frame
Illness Perception	Cognitive and emotional representations formed about one's illness measured via Brief Illness Perception Questionnaire (minimum 0, maximum 80; higher scores indicate more severe illness impact)	8 weeks
Self-efficacy

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

self-identify as Black or Hispanic/Latino
diagnosis of Crohn's disease or ulcerative colitis
ability to provide informed consent in English
basic computer skills (i.e. ability to self-complete online questionnaire)
elevated psychological distress

Exclusion Criteria:

severe psychological distress
active suicidality, past suicide attempt, or psychiatric hospitalization

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Ruby Greywoode, MD	Montefiore Medical Center	Principal Investigator

Locations

Not provided

IPD Sharing Statement Module

Plan to Share IPD

Description

Not provided

Types

Not provided

Time Frame

Not provided

Access Criteria

Not provided

URL

Not provided

Condition Browse Module

MeSH Terms

ID	Term
D015212	Inflammatory Bowel Diseases

Ancestor Terms

ID	Term
D005759	Gastroenteritis
D005767	Gastrointestinal Diseases
D004066	Digestive System Diseases
D007410	Intestinal Diseases

Browse Leaves

Not provided

Browse Branches

Not provided

A task-specific construct of the perception of one's ability to manage a given situation measured via PROMIS-Self Efficacy in Managing Emotions questionnaire (T score 50 is the mean, higher scores indicate greater self efficacy)