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Behavioral Intervention

Biofeedback 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

Ages 13 through 18 years inclusive

Be younger than 65 years old

Must not have

Diagnosis of abnormal thyroid function

Treatment with any drug with known autonomic cardiovascular influences including beta-blockers, central sympatholytic agents, or antidepressants

Timeline

Screening 3 weeks

Treatment Varies

Follow Up baseline, 6 weeks post-intervention

Awards & highlights

No Placebo-Only Group

Summary

This trial aims to study a coping skills program for young people with inflammatory bowel disease. The program will use biofeedback to help manage the autonomic dysfunction associated with the disease. Participants will be divided into

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

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I am between 13 and 18 years old.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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My thyroid function is not normal.

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I am not taking medication that affects my heart rate or blood pressure.

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I have a developmental disability that affects my daily life and treatment response.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ baseline, 6 weeks post-intervention

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

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

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

0 / 4Eligibility criteria met