Biofeedback in Pediatric Inflammatory Bowel Disease

NCT ID: NCT04269720

Last Updated: 2022-12-23

Basic Information

• Recruitment Status: WITHDRAWN
• Clinical Phase: NA
• Study Classification: INTERVENTIONAL
• Study Start Date: 2022-09-09
• Study Completion Date: 2025-02-01

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.

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

Keywords

biofeedback; pediatric

Study Design

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

Study Groups

Control

Participants will not receive biofeedback intervention.

Group Type: NO_INTERVENTION

No interventions assigned to this group

Biofeedback

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

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, 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.

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, 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.

Intervention Type: BEHAVIORAL

Other Intervention Names

Inner Balance

Eligibility Criteria

Inclusion Criteria

1. Age 8-17 years

2. Referred for a diagnostic colonoscopy with strong clinical concern for IBD

3. Live within a 2 hour drive of NCH

There is one additional inclusion criterion for Phase 2:

1. Patients have been diagnosed with IBD

Exclusion Criteria

1. 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.

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

Ross Maltz

OTHER

Sponsor Role: lead

Responsible Party

Ross Maltz

Principal Investigator

Responsibility Role: SPONSOR_INVESTIGATOR

Principal Investigators

Ross Maltz, MD

Role: PRINCIPAL_INVESTIGATOR

Nationwide Children's Hospital

Other Identifiers

IRB18-01100

Identifier Type: -

Identifier Source: org_study_id