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Internet based cognitive behavioral therapy for Inflammatory Bowel Disease
N/A
Waitlist Available
Led By Ruby Greywoode, MD
Research Sponsored by Montefiore Medical Center
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
race/ethnicity self-identified as Black/African American or Hispanic/Latino
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 4 weeks post-intervention
Awards & highlights
Study Summary
This trial looks at whether an internet-based cognitive behavioral therapy (iCBT) can help reduce psychological distress in IBD patients of color.
Eligible Conditions
- Inflammatory Bowel Disease
- Stress
- Depression and Anxiety
- Crohn's Disease
- Ulcerative Colitis
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
You identify as Black/African American or Hispanic/Latino.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ 4 weeks post-intervention
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~4 weeks post-intervention
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Anxiety and/or depression
Secondary outcome measures
Crohn's Disease Activity
Health-related Quality-of-Life
Perceived Stress Score
+1 moreTrial Design
2Treatment groups
Experimental Treatment
Active Control
Group I: Internet-based cognitive behavioral therapyExperimental Treatment1 Intervention
The iCBT platform selected for use in this study (Sanvello™) is an evidence-based mobile app created by clinical experts that has been shown to decrease depression, anxiety, and stress and to increase self-efficacy in a non-IBD population.15 App features include: daily mood tracking; guided journeys (e.g. psychoeducational content providing background information about cognitive behavioral therapy and instructing users on how to use app tools to maintain motivation and interest); coping tools (e.g. meditation, goal setting, and negative thought redirecting activities); weekly progress assessments; community support board.
Group II: Digital mood trackingActive Control1 Intervention
The digital mood tracking application (app) selected for this study (PixelTM) allows participants to log their mood each day by way of a facial expression emoji and a free-text box. This app is commercially available free of charge through iOS and Android app stores with English and Spanish language options.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Internet based cognitive behavioral therapy
2021
N/A
~60
Find a Location
Who is running the clinical trial?
Montefiore Medical CenterLead Sponsor
440 Previous Clinical Trials
581,627 Total Patients Enrolled
Ruby Greywoode, MDPrincipal InvestigatorMontefiore Medical Center
1 Previous Clinical Trials
400 Total Patients Enrolled
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
What is the upper limit of participants in this research project?
"Affirmative, the information on clinicaltrials.gov indicates that this study is actively seeking participants. It was first posted in November 2021 and most recently updated at the end of August 2022. The trial requires 50 volunteers from one location to take part."
Answered by AI
Are there any more opportunities for enrolment into this research project?
"Affirmative. Clinical trials listing on clinicaltrials.gov validate that this trial, initially shared on November 1st 2021, is searching for suitable participants. The research project needs to find 50 people across one centre."
Answered by AI
Who else is applying?
What state do they live in?
Rhode Island
How old are they?
18 - 65
What portion of applicants met pre-screening criteria?
Met criteria
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