Biofeedback for Inflammatory Bowel Disease

Recruiting in Palo Alto (17 mi)

+2 other locations

Overseen byBonney Reed, PhD

Age: < 65

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Academic

Recruiting

Sponsor: Emory University

No Placebo Group

Trial Summary

What is the purpose of this trial?

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.

Eligibility Criteria

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.

Inclusion Criteria

I have a parent/guardian willing to complete surveys for the study.

Youth and parent agree to the conditions of study participation, including randomization, participation in intervention, and follow-up assessments

Speak English

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Exclusion Criteria

My thyroid function is not normal.

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

I have been diagnosed with a chronic condition like diabetes or epilepsy.

See 1 more

Trial Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

1 visit (in-person or virtual)

Treatment

Participants receive a biofeedback enhanced cognitive behaviorally based coping skills treatment over 6 weeks

6 weeks

6 visits (virtual)

Follow-up

Participants are monitored for safety and effectiveness after treatment

20 weeks

4 visits (in-person)

Treatment Details

Interventions

Biofeedback Enhanced Treatment (Behavioral Intervention)

Trial OverviewThe 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.

Participant Groups

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).