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Behavioral Intervention

Biofeedback Therapy for Inflammatory Bowel Disease

N/A
Waitlist Available
Led By Bonnie Reed, PhD
Research Sponsored by Emory University
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Ages 8 through 17 years inclusive
Diagnosed with biopsy-confirmed IBD
Must not have
Parent is unwilling to participate.
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 6 weeks (end of treatment) and 2 months post treatment
Awards & highlights

Summary

This trial tests if teaching stress management and using biofeedback can help young people with newly diagnosed IBD reduce anxiety, depression, and disease symptoms.

Who is the study for?
This trial is for young people aged 8-17 with a confirmed diagnosis of inflammatory bowel disease (IBD). They must speak English fluently and be accompanied by a parent willing to participate. Eligible participants are those showing signs of depression or anxiety but do not have autism or an intellectual disability.
What is being tested?
The study is testing Biofeedback Enhanced Treatment on youths with IBD, comparing their stress levels and mental health symptoms to healthy individuals without IBD. It's designed to track how the body responds physiologically to psychological states over time.
What are the potential side effects?
Since this trial focuses on biofeedback and assessment rather than medication, traditional side effects like you might see with drugs aren't expected. However, discussing sensitive topics may cause temporary emotional discomfort.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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I am between 8 and 17 years old.
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I have been diagnosed with IBD through a biopsy.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:
Select...
My parent is not willing to participate.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~6 weeks (end of treatment) and 2 months post treatment
This trial's timeline: 3 weeks for screening, Varies for treatment, and 6 weeks (end of treatment) and 2 months post treatment for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
Changes in the retention rate
Changes in treatment satisfaction
Secondary study objectives
Changes in autonomic reactivity will be summarized within groups at each study time-point.
Changes in clinical scores (clinical symptoms) will be summarized within groups at each study time-point.
Changes in clinical scores (depression) will be summarized within groups at each study time-point.
+1 more

Trial Design

2Treatment groups
Experimental Treatment
Active Control
Group I: Biofeedback Enhanced TreatmentExperimental Treatment1 Intervention
Participants in this group will participate in biofeedback enhanced cognitive behaviorally based coping skills treatment. Treatment will consist of a 6-visit group intervention conducted online, via Emory zoom. Groups will include 5-8 patients each. Sessions will include brief, daily homework to facilitate mastery that is developmentally tailored to youth (e.g., practice skills with support from phone or tablet apps). Groups will meet approximately every week for 6 weeks. Advanced Ph.D. students in clinical psychology and Principal Investigator will deliver the treatment protocol. They will complete questionnaires before and after each session to measure autonomic reactivity in response to stress induction and coping strategies.
Group II: Wait-list controlActive Control1 Intervention
Participants randomized to the wait-list control group will complete the same measures of lifetime stress, autonomic reactivity, depression, anxiety. The identical treatment will be offered to control participants after the 6-week time point.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Biofeedback Enhanced Treatment
2022
N/A
~40

Research Highlights

Information in this section is not a recommendation. We encourage patients to speak with their healthcare team when evaluating any treatment decision.
Mechanism Of Action
Side Effect Profile
Prior Approvals
Other Research
The most common treatments for Inflammatory Bowel Disease (IBD) include 5-aminosalicylic acid (5-ASA) agents, corticosteroids, immunomodulators, and biologics. 5-ASA agents, such as mesalamine, reduce inflammation in the lining of the intestines by inhibiting the production of inflammatory chemicals. Corticosteroids, like prednisone, suppress the overall immune response to quickly reduce inflammation but are typically used short-term due to side effects. Immunomodulators, such as azathioprine, alter the immune system's activity to prevent ongoing inflammation. Biologics, including infliximab, target specific proteins involved in the inflammatory process, providing a more targeted approach to reducing inflammation. Understanding these mechanisms is crucial for IBD patients as it helps tailor treatment plans to effectively manage symptoms, reduce flare-ups, and improve quality of life.
Clinical communication in inflammatory bowel disease: a systematic review of the study of clinician-patient dialogue to inform research and practice.The future of IBD treatment.

Find a Location

Who is running the clinical trial?

Emory UniversityLead Sponsor
1,686 Previous Clinical Trials
2,599,605 Total Patients Enrolled
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)NIH
2,424 Previous Clinical Trials
4,324,895 Total Patients Enrolled
Children's Healthcare of AtlantaOTHER
168 Previous Clinical Trials
107,073 Total Patients Enrolled

Media Library

Biofeedback Enhanced Treatment (Behavioral Intervention) Clinical Trial Eligibility Overview. Trial Name: NCT05202418 — N/A
Biofeedback Enhanced Treatment (Behavioral Intervention) 2023 Treatment Timeline for Medical Study. Trial Name: NCT05202418 — N/A
Inflammatory Bowel Disease Research Study Groups: Wait-list control, Biofeedback Enhanced Treatment
Inflammatory Bowel Disease Clinical Trial 2023: Biofeedback Enhanced Treatment Highlights & Side Effects. Trial Name: NCT05202418 — N/A
~11 spots leftby Oct 2025