Impact of a Biofeedback Intervention on Microbiome, Metabolome, and Clinical Outcomes in Pediatric IBD (Study 2)

NCT ID: NCT04296110

Last Updated: 2024-08-15

Basic Information

• Recruitment Status: TERMINATED
• Clinical Phase: NA
• Total Enrollment: 48 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2020-03-12
• Study Completion Date: 2024-08-14

Brief Summary

This prospective, randomized, longitudinal, controlled study will enroll pediatric CD patients with inflammatory, non-stricturing, and non-penetrating disease type with mild/quiescent disease based on Pediatric Crohn's Disease Activity Index (PCDAI). Participants will be randomized to receive HRV biofeedback intervention daily for 12 weeks or to music relaxation therapy.

Detailed Description

The inflammatory bowel diseases (IBD), which include Crohn's disease (CD) and ulcerative colitis (UC), affects 3 million Americans. In approximately 25-30% of patients, onset of these chronic diseases occurs prior to the age of 20. Despite medical advances in new therapies, the clinical remission rate on biologics is less than 50% and a significant number of patients will lose response to anti-TNF therapy over time. In addition, patients that require a change in therapy will have a lower response rate to a different biologic. Additional therapies and mechanisms that affect disease activity need to be investigated to identify complimentary treatments that can further impact remission rates without increasing side effects such as lymphoma.

Environmental factors, such as stressor exposure, can exacerbate mucosal inflammation. Patients with IBD report a lower quality of life, as well as increased anxiety and depression. Psychological interventions may improve disease activity. This study will test, using a randomized clinical trial (RCT) design, whether biofeedback intervention will attenuate disease activity. If efficacious, this study will provide a rationale for establishing biofeedback as a complimentary therapy to standard of care to ameliorate stress-induced increases in chronic inflammation.

Conditions

IBD

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Control

Participants will receive music relaxation therapy. They will be asked to listen to designated music daily for 12 weeks.

Group Type: ACTIVE_COMPARATOR

Music Relaxation Therapy

Intervention Type: OTHER

We will determine what genre of music is most relaxing to them and ask them to listen to this type of music using the spotify app for 5-15 mins a day for 12 weeks. If they do not have access to a device that they can listen to spotify on, an ipod will be provided. They will be asked to complete a 2-question survey via Redcap daily that asks them if they have listened to the designated music that day and for how long.

Biofeedback

Participants will receive a biofeedback intervention. They will be asked to practice breathing at their designated resonance frequency using provided biofeedback device daily for 12 weeks.

Group Type: EXPERIMENTAL

Biofeedback

Intervention Type: BEHAVIORAL

They will also be taught how to use the biofeedback app and Inner Balance device. Additionally, they will also be educated on the principles of biofeedback and its benefits and taught how to maximize HRV by using self-regulation breathing techniques.They will be given an Inner Balance device, which is an ear sensor that connects to an apple device that measures heart rate variability (HRV) and gives them access to an app that is designed to help them improve their HRV. They will be asked to practice breathing at their resonance frequency using the Inner Balance device daily for 5-15 mins for the duration of the 12-week intervention. Patients and the research coordinator will have access to all of their sessions and results. The research coordinator will monitor compliance via the Heartcloud associated with their device and encourage adherence throughout the intervention.

Interventions

Biofeedback

They will also be taught how to use the biofeedback app and Inner Balance device. Additionally, they will also be educated on the principles of biofeedback and its benefits and taught how to maximize HRV by using self-regulation breathing techniques.They will be given an Inner Balance device, which is an ear sensor that connects to an apple device that measures heart rate variability (HRV) and gives them access to an app that is designed to help them improve their HRV. They will be asked to practice breathing at their resonance frequency using the Inner Balance device daily for 5-15 mins for the duration of the 12-week intervention. Patients and the research coordinator will have access to all of their sessions and results. The research coordinator will monitor compliance via the Heartcloud associated with their device and encourage adherence throughout the intervention.

Intervention Type: BEHAVIORAL

Music Relaxation Therapy

We will determine what genre of music is most relaxing to them and ask them to listen to this type of music using the spotify app for 5-15 mins a day for 12 weeks. If they do not have access to a device that they can listen to spotify on, an ipod will be provided. They will be asked to complete a 2-question survey via Redcap daily that asks them if they have listened to the designated music that day and for how long.

Intervention Type: OTHER

Other Intervention Names

Inner Balance; MRT

Eligibility Criteria

Inclusion Criteria

1. Age 8-17 years

2. Have inflammatory, non-stricturing, and non-penetrating CD with either mild/quiescent disease based on PCDAI or PGA

3. Live within a 2 hour drive of NCH

Exclusion Criteria

1. Participants are excluded if they have ulcerative colitis, penetrating and/or stricturing CD, have a comorbid chronic illness, perianal disease, taking antibiotics within the last 3 months, psychological disorders that they are undergoing treatment or taking medication for at that time, presence of a heart rhythm or other abnormality of heart rhythm on screening EKG, or undergoing psychological treatments such as cognitive behavioral therapy, mindfulness, or biofeedback therapy at the time of enrollment.

2. Age and language are limited by the demands of the study (questionnaire completion

• Minimum Eligible Age: 8 Years
• Maximum Eligible Age: 17 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Nationwide Children's Hospital

OTHER

Sponsor Role: lead

Responsible Party

Ross Maltz

Principal Investigator

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Ross Maltz, MD

Role: PRINCIPAL_INVESTIGATOR

Nationwide Childrens Hospital

Locations

Nationwide Childrens Hospital GI Clinic

Columbus, Ohio, United States

Countries

United States

Other Identifiers

18-01100

Identifier Type: -

Identifier Source: org_study_id