Biofeedback Therapy for Inflammatory Bowel Disease

Recruiting in Palo Alto (17 mi)

+2 other locations

Overseen by Bonnie Reed, PhD

Age: < 65

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Academic

Waitlist Available

Sponsor: Emory University

No Placebo Group

Trial Summary

What is the purpose of this trial?

This trial tests if teaching stress management and using biofeedback can help young people with newly diagnosed IBD reduce anxiety, depression, and disease symptoms.

Research Team

Bonnie Reed, PhD

Principal Investigator

Emory University

Eligibility Criteria

This trial is for young people aged 8-17 with a confirmed diagnosis of inflammatory bowel disease (IBD). They must speak English fluently and be accompanied by a parent willing to participate. Eligible participants are those showing signs of depression or anxiety but do not have autism or an intellectual disability.

Inclusion Criteria

English fluency for parent and child participants.

Positive depression or anxiety symptom screen using the patient health questionnaire (PHQ-9) or Patient-Reported Outcomes Measurement Information System (PROMIS) Pediatric Anxiety measures

Accompanied by at least 1 parent/guardian who is willing to participate

Exclusion Criteria

You have been diagnosed with autism.

My parent is not willing to participate.

You have been previously diagnosed with an intellectual disability.

Treatment Details

Interventions

• Biofeedback Enhanced Treatment (Behavioral Intervention)

Trial Overview The study is testing Biofeedback Enhanced Treatment on youths with IBD, comparing their stress levels and mental health symptoms to healthy individuals without IBD. It's designed to track how the body responds physiologically to psychological states over time.

Participant Groups

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 each. Sessions will include brief, daily homework to facilitate mastery that is developmentally tailored to youth (e.g., practice skills with support from phone or tablet apps). Groups will meet approximately every week for 6 weeks. Advanced Ph.D. students in clinical psychology and Principal Investigator will deliver the treatment protocol. They will complete questionnaires before and after each session to measure autonomic reactivity in response to stress induction and coping strategies.

Group II: Wait-list control Active Control 1 Intervention

Participants randomized to the wait-list control group will complete the same measures of lifetime stress, autonomic reactivity, depression, anxiety. The identical treatment will be offered to control participants after the 6-week time point.

Who Is Running the Clinical Trial?

Emory University

Lead Sponsor

Trials

1,735

Recruited

2,605,000+

Dr. R. Donald Harvey

Emory University

Chief Medical Officer

MD from Emory University School of Medicine

Dr. George Painter

Emory University

Chief Executive Officer since 2013

PhD in Synthetic Organic Chemistry from Emory University

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

Collaborator

Trials

2,513

Recruited

4,366,000+

Dr. Griffin P. Rodgers

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

Chief Executive Officer since 2007

MD, M.A.C.P.

Dr. Griffin P. Rodgers

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

Chief Medical Officer since 2007

MD, M.A.C.P.

Children's Healthcare of Atlanta

Collaborator

Trials

172

Recruited

108,000+

Donna Hyland

Children's Healthcare of Atlanta

Chief Executive Officer since 2008

Bachelor of Science in Management from Georgia Tech, MBA from Northwestern University’s Kellogg School of Management

Dr. Srikant Iyer

Children's Healthcare of Atlanta

Chief Medical and Quality Officer

MD from the University of North Carolina at Chapel Hill, Master of Public Health from Harvard University