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?

This trial tests a special online program designed to help young people with inflammatory bowel disease (IBD) manage their symptoms more effectively. The program uses biofeedback, a technique that helps individuals control certain body functions, like heart rate, by using signals from their own body. Participants will be divided into two groups: one will receive the Biofeedback Enhanced Treatment immediately, while the other will begin the treatment after a waiting period. This trial suits teens aged 13 to 18 who have been diagnosed with IBD for at least four months and sometimes experience anxiety or depression. As an unphased study, it offers a unique opportunity to explore innovative symptom management techniques in a supportive environment.

Will I have to stop taking my current medications?

If you are taking medications like beta-blockers, central sympatholytic agents, or antidepressants, you will need to stop them to participate in this trial.

What prior data suggests that this biofeedback enhanced treatment is safe for youth with inflammatory bowel disease?

In a previous study, researchers tested biofeedback-enhanced cognitive-behavioral therapy on young people with inflammatory bowel disease (IBD) and found it well-tolerated. Participants reported no serious side effects, indicating the treatment's safety for most. Another study also used biofeedback for young people with IBD, aiming to reduce symptoms without major safety issues. Overall, research suggests that biofeedback, especially when combined with therapy, offers a safe option for people with IBD. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about biofeedback for inflammatory bowel disease (IBD) because it offers a novel approach to managing the condition. Unlike standard treatments like anti-inflammatory drugs, immunosuppressants, or biologics, biofeedback focuses on enhancing patients' coping skills through cognitive-behavioral therapy combined with real-time feedback about their physiological states. This technique is delivered in a group setting online, making it accessible and potentially more engaging. By empowering patients to actively manage their symptoms, this method could complement existing therapies and improve quality of life for those with IBD.

What evidence suggests that biofeedback enhanced treatment is effective for inflammatory bowel disease?

This trial will compare Biofeedback Enhanced Treatment with a wait-list control group for young people with inflammatory bowel disease (IBD). Research has shown that biofeedback-enhanced cognitive-behavioral therapy (CBT) can improve well-being in young people with IBD. In past studies, teenagers who received this therapy experienced fewer stomach problems and reduced anxiety compared to those who did not. The therapy teaches patients to control their heart rate, which can help calm the body's stress response. By doing so, patients might manage their IBD symptoms more effectively. Overall, early results suggest that this therapy could enhance the quality of life for young people with IBD. ^{1 3 6 7 8}

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

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

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

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+

Citations

1. pubmed.ncbi.nlm.nih.gov pubmed.ncbi.nlm.nih.gov/40296354/

Biofeedback-Enhanced Cognitive-Behavioral Therapy ... Biofeedback-Enhanced Cognitive-Behavioral Therapy Delivered Virtually to Youth With Inflammatory Bowel Disease: A Randomized Controlled Trial. ...

2. clinicaltrials.gov clinicaltrials.gov/study/NCT06537258

Heart Rate Variability and Inflammatory Bowel Disease The goals of this study are to test the effectiveness of a virtually delivered, group-based coping skills treatment program incorporating heart rate variability ...

3. researchgate.net researchgate.net/publication/391275386_Biofeedback-Enhanced_Cognitive-Behavioral_Therapy_Delivered_Virtually_to_Youth_With_Inflammatory_Bowel_Disease_A_Randomized_Controlled_Trial

Biofeedback-Enhanced Cognitive–Behavioral Therapy ... Adolescents reported reductions in GI symptoms and perceived stress compared to controls and reductions in symptoms of anxiety within the ...

4. trialfinder.panfoundation.org trialfinder.panfoundation.org/en-US/trial/listing/586824

Heart Rate Variability and Inflammatory Bowel Disease The investigators will enroll participants with IBD in a biofeedback enhanced cognitive behaviorally based coping skills treatment.

5. mdpi.com mdpi.com/2227-9067/4/4/22

Mind–Body Interventions for Pediatric Inflammatory Bowel ... The strongest evidence for the efficacy of hypnotherapy in IBD is its association with reduced IBD related inflammation and improved quality of life. Mixed ...

6. clinicaltrials.gov clinicaltrials.gov/study/NCT04269720

Biofeedback in Pediatric Inflammatory Bowel Disease This study will test, using a randomized clinical trial (RCT) design, whether biofeedback intervention will attenuate disease activity. If efficacious, this ...

7. academic.oup.com academic.oup.com/ibdjournal/issue/31/10

Volume 31 Issue 10 | Inflammatory Bowel Diseases Supplementary data · Biofeedback-Enhanced Cognitive–Behavioral Therapy Delivered Virtually to Youth With Inflammatory Bowel Disease: A Randomized Controlled ...

8. pubmed.ncbi.nlm.nih.gov pubmed.ncbi.nlm.nih.gov/31713856/

Biofeedback for treatment of irritable bowel syndrome There is currently not enough evidence to assess whether biofeedback interventions are effective for controlling symptoms of IBS.