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Behavioral Intervention

Biofeedback Enhanced Treatment for Inflammatory Bowel Disease

N/A
Waitlist Available
Led By Bonney 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
(a) Diagnosis with biopsy-confirmed IBD for at least 4 months, (b) ages 13 through 18 years inclusive, (c) speak English, (d) enrolling with at least 1 parent/guardian who is willing to participate by completing surveys, (e) positive depression or anxiety screen using the PHQ-4, (f) access to home internet in order to participate in virtual intervention, (g) youth and parent agree to the conditions of study participation, including randomization, participation in intervention, and follow-up assessments, (h) youth is medically approved to engage in normal daily activities (e.g., attend school, extracurricular activities)
Be younger than 65 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up baseline, 6 weeks post-intervention
Awards & highlights

Summary

The goals of this study are to test the effectiveness of a virtually delivered, group-based coping skills treatment program incorporating heart rate variability biofeedback to target autonomic dysfunction in youth diagnosed with inflammatory bowel disease (IBD). The investigators will enroll participants with IBD in a biofeedback enhanced cognitive behaviorally based coping skills treatment. Participants will be randomized to biofeedback enhanced treatment or wait-list control.

Who is the study for?
This trial is for young people with Inflammatory Bowel Disease (IBD). Participants should be diagnosed with IBD to qualify. Specific inclusion and exclusion criteria details are not provided, but typically these would outline the age range, disease severity, and any other health conditions that might disqualify someone from participating.
What is being tested?
The study is testing a coping skills treatment program that includes heart rate variability biofeedback. It's delivered virtually in a group setting. The effectiveness of this program will be compared to a wait-list control group to see if it helps manage autonomic dysfunction in IBD patients.
What are the potential side effects?
Since the intervention involves non-invasive biofeedback and cognitive behavioral therapy, significant side effects are unlikely. However, participants may experience discomfort or emotional distress when discussing their condition or learning new coping strategies.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~baseline, 6 weeks post-intervention
This trial's timeline: 3 weeks for screening, Varies for treatment, and baseline, 6 weeks post-intervention 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 psychological distress

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. Groups will meet approximately each week for 6 weeks. Patients will also rate their disease symptoms and measures of clinical disease activity will be collected via chart review. Clinical assessments will occur at baseline within 1 week prior to starting treatment (T1), at treatment end or 6 weeks after baseline (T2), 14 weeks after baseline to capture 2-month follow-up after treatment (T3) and at 26 weeks after baseline (T4).
Group II: Wait-list controlActive Control1 Intervention
Participants randomized to the waitlist control group will complete the same assessment protocol at the time of randomization (Baseline) and again 6 weeks later. They will then be invited to begin treatment and will repeat the assessments at posttest and again at 14 and 26-week follow-up (for a total of 5 assessments).
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Biofeedback Enhanced Treatment
2022
N/A
~40

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Who is running the clinical trial?

Emory UniversityLead Sponsor
1,665 Previous Clinical Trials
2,574,957 Total Patients Enrolled
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)NIH
2,395 Previous Clinical Trials
4,318,399 Total Patients Enrolled
Bonney Reed, PhDPrincipal InvestigatorEmory University
~85 spots leftby Oct 2028
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