Biofeedback for Inflammatory Bowel Disease

Recruiting at 2 trial locations

Overseen By Bonney Reed, PhD

Age: < 65

Sex: Any

Trial Phase: Academic

Sponsor: Emory University

Must not be taking: Beta-blockers, Antidepressants, others

Disqualifiers: Developmental disabilities, Chronic disease, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: 11

Duration: 6 weeks

128 Participants Needed

What You Need to Know Before You Apply

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.

Who Is on the Research Team?

Bonney Reed, PhD

Principal Investigator

Emory University

Are You a Good Fit for This Trial?

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

I have been diagnosed with IBD through a biopsy for over 4 months.

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.

Timeline for a Trial Participant

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)

What Are the Treatments Tested in This Trial?

Interventions

• Biofeedback Enhanced Treatment

Trial Overview 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.

How Is the Trial Designed?

Group I: Biofeedback Enhanced Treatment Experimental Treatment 1 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 control Active Control 1 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).

Who Is Running the Clinical Trial?

Emory University

Lead Sponsor

Trials

1,735

Recruited

2,605,000+

National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)

Collaborator

Trials

2,513

Recruited

4,366,000+