Biofeedback in Pediatric Inflammatory Bowel Disease

NCT04269720 | Withdrawn DMC

• 1 other identifier: IRB18-01100
• Study Type: interventional
• Target: N/A
• Locations: 0 countries
• Sites: N/A

Brief Summary

This prospective, randomized, longitudinal, controlled project will occur in two phases. Phase 1 is the pre-diagnosis data collection for treatment-naïve participants who are referred for a diagnostic endoscopy/colonoscopy due to suspicion of IBD. Phase 2 (RCT) is only for patients who are diagnosed with IBD. These patients will be randomized to receive biofeedback intervention daily for 8 weeks or no biofeedback intervention. All participants will receive physician directed standard of care treatment.

Conditions

IBD

Keywords

biofeedback; pediatric

Outcome Measures

Primary Outcomes (9)

• Crohn's disease mucosal healing

  Simple endoscopic score for CD (SES-CD) scores ileum, right colon, transverse, left colon, and rectum for the degree of ulceration. Scale ranges from 0-3, total score is calculated from sum of all variables for all 5 locations. Scores range from 0-60. Higher scores indicate worse inflammation.

  pre-diagnosis to 12 month follow up

• Ulcerative Colitis Mucosal healing

  Mayo endoscopic scores for the degree of ulceration. Scores range from 0-3. Higher scores indicate worse inflammation.

  pre-diagnosis to 12 month follow up

• Disease activity( Fecal calprotectin)

  Fecal calprotectin levels from stool

  pre diagnosis 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 pre-diagnosis, post-intervention, 4 months post-intervention, and 12 month follow up. Higher scores indicate more severe disease. Scores range from 0-100.

  pre diagnosis to 12 month follow up

• Disease Activity ( Ulcerative Colitis)

  Pediatric Ulcerative Colitis Activity Index total score. A standard Pediatric Ulcerative Colitis Activity Index. a standard measure of disease severity that is comprised pain severity, stool frequency and consistency, rectal bleeding, nocturnal bowel movements, and limitation of activities. The Pediatric Ulcerative Colitis Activity Index total score will be used from pre-diagnosis, post-intervention, 4 months post-intervention, and 12 month follow up. Higher scores indicate more severe disease. Scores range from 0-85.

  pre diagnosis 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 pre-diagnosis, post-intervention, 4 months post-intervention, and 12 month follow up.

  pre-diagnosis 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 pre-diagnosis, post-intervention, 4 months post-intervention, and 12 month follow up.

  pre-diagnosis to 12 month follow up

• Pediatric Quality of life

  PedsQL. Scores range from 0-100 with higher scores indicating higher quality of life. Total score will be used from pre-diagnosis, post-intervention, 4 months post-intervention, and 12 month follow up.

  pre-diagnosis 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 pre-diagnosis, post-intervention, 4 months post-intervention, and 12 month follow up.

  pre-diagnosis to 12 month follow up.

Secondary Outcomes (2)

• Stress-related changes in the microbiome

  pre diagnosis to 12 month follow up

• Stress-related changes in the metabolome.

  pre diagnosis to 12 month follow up

Study Arms (2)

Control

NO INTERVENTION

Participants will not receive biofeedback intervention.

Biofeedback

EXPERIMENTAL

Participants will receive a biofeedback intervention daily for 8 weeks. Each biofeedback session lasts approximately 10 minutes.

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, guided imagery, and/ or self-talk.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 use this device daily for 10 mins for the duration of the 8-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 8-week biofeedback intervention.

Also known as: Inner Balance

Biofeedback

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
• Referred for a diagnostic colonoscopy with strong clinical concern for IBD
• Live within a 2 hour drive of NCH
• \. Patients have been diagnosed with IBD

You may not qualify if:

• Participants are excluded if they have a comorbid chronic illness, perianal disease, current corticosteroid treatment, taking antibiotics within the last 3 months, psychological disorders that they are undergoing treatment or taking medication for at that time, 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

• Ross Maltz: lead

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 Children's 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: SPONSOR INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: February 12, 2020
• First Posted: February 17, 2020
• Study Start: September 9, 2022
• Primary Completion: February 1, 2024
• Study Completion: February 1, 2025
• Last Updated: December 23, 2022

Record last verified: 2022-12

Data Sharing

• IPD Sharing: Will not share