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

NCT04296110 | Terminated DMC

• 1 other identifier: 18-01100
• Study Type: interventional
• Target: 48
• Locations: 1 country
• Sites: 1

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.

Conditions

IBD

Keywords

biofeedback; pediatric

Outcome Measures

Primary Outcomes (6)

• Disease activity( Fecal calprotectin)

  Fecal calprotectin levels from stool

  enrollment to 12 month follow up

• Disease Activity (Crohn's disease)

  Pediatric Crohn's Disease Activity Index total score. A standard measure of disease severity that is comprised of information obtained from patient recall (pain severity, stool frequency, limitation of activities), examination (weight, height, abdominal tenderness, perirectal disease, extra- intestinal manifestations), and laboratory data. The Pediatric Crohn's Disease Activity Index total score will be used from baseline, post-intervention, 3 months post-intervention, and 12 month follow up. Higher scores indicate more severe disease. Scores range from 0-100.

  enrollment to 12 month follow up

• Stress

  PROMIS Pediatric Psychological Stress Experiences.Scores range from 0-60, with higher scores indicating higher levels of stress.Total score will be used from baseline, post-intervention, 3 months post-intervention, and 12 month follow up.

  enrollment to 12 month follow up

• Anxiety

  PROMIS Pediatric Anxiety Short Form. Scores range from 0-60, with higher scores indicating higher levels of anxiety. Total score will be used from baseline, post-intervention, 3 months post-intervention, and 12 month follow up.

  enrollment to 12 month follow up

• Pediatric Quality of Life: scale

  PedsQL. Scores range from 0-100 with higher scores indicating higher quality of life. Total score will be used from baseline, post-intervention, 3 months post-intervention, and 12 month follow up.

  enrollment to 12 month follow up

• Depression

  Children's Depression Inventory short form. Scores range from 0-54, with higher scores indicating higher levels of depression. Total score will be used from baseline, post-intervention, 3 months post-intervention, and 12 month follow up.

  enrollment to 12 month follow up

Secondary Outcomes (2)

• Stress-related changes in the microbiome

  enrollment to 12 month follow up

• Stress-related changes in the metabolome.

  enrollment to 12 month follow up

Study Arms (2)

Control

ACTIVE COMPARATOR

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

Other: Music Relaxation Therapy

Biofeedback

EXPERIMENTAL

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.

Behavioral: Biofeedback

Interventions

Biofeedback 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.

Also known as: Inner Balance

Biofeedback

Music Relaxation Therapy 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.

Also known as: MRT

Control

Eligibility Criteria

• Age: 8 Years - 17 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• Age 8-17 years
• Have inflammatory, non-stricturing, and non-penetrating CD with either mild/quiescent disease based on PCDAI or PGA
• Live within a 2 hour drive of NCH

You may not qualify if:

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

Sponsors & Collaborators

• Nationwide Children's Hospital: lead

Study Sites (1)

Nationwide Childrens Hospital GI Clinic

Columbus, Ohio, 43205, United States

Location

MeSH Terms

Interventions

Biofeedback, Psychology

Intervention Hierarchy (Ancestors)

Mind-Body Therapies; Complementary Therapies; Therapeutics; Behavior Therapy; Psychotherapy; Behavioral Disciplines and Activities; Feedback, Psychological

Study Officials

• Ross Maltz, MD

  Nationwide Childrens Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: March 3, 2020
• First Posted: March 5, 2020
• Study Start: March 12, 2020
• Primary Completion: August 14, 2024
• Study Completion: August 14, 2024
• Last Updated: August 15, 2024

Record last verified: 2024-08

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)