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Behavioral Intervention

Biofeedback Therapy for Inflammatory Bowel Disease

N/A

Waitlist Available

Led By Bonnie Reed, PhD

Research Sponsored by Emory University

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Ages 8 through 17 years inclusive

Diagnosed with biopsy-confirmed IBD

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 6 weeks (end of treatment) and 2 months post treatment

Awards & highlights

Study Summary

This trial looks at the relationship between psychological symptoms and physical functioning in young people with inflammatory bowel disease, compared to healthy controls.

Who is the study for?

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.Check my eligibility

What is being tested?

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.See study design

What are the potential side effects?

Since this trial focuses on biofeedback and assessment rather than medication, traditional side effects like you might see with drugs aren't expected. However, discussing sensitive topics may cause temporary emotional discomfort.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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I am between 8 and 17 years old.

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I have been diagnosed with IBD through a biopsy.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 6 weeks (end of treatment) and 2 months post treatment

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~6 weeks (end of treatment) and 2 months post treatment

This trial's timeline: 3 weeks for screening, Varies for treatment, and 6 weeks (end of treatment) and 2 months post treatment for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

Changes in the retention rate

Changes in treatment satisfaction

Secondary outcome measures

Changes in autonomic reactivity will be summarized within groups at each study time-point.

Changes in clinical scores (clinical symptoms) will be summarized within groups at each study time-point.

Changes in clinical scores (depression) will be summarized within groups at each study time-point.

+1 more

Trial Design

2Treatment groups

Experimental Treatment

Active Control

Group I: Biofeedback Enhanced TreatmentExperimental Treatment1 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 controlActive Control1 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.

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Biofeedback Enhanced Treatment

2022

N/A

~40

0 / 2Eligibility criteria met

Find a Location

Who is running the clinical trial?

Emory UniversityLead Sponsor

1,636 Previous Clinical Trials

2,560,533 Total Patients Enrolled

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

2,357 Previous Clinical Trials

4,315,146 Total Patients Enrolled

Children's Healthcare of AtlantaOTHER

165 Previous Clinical Trials

105,090 Total Patients Enrolled

Media Library

Biofeedback Enhanced Treatment (Behavioral Intervention) Clinical Trial Eligibility Overview. Trial Name: NCT05202418 — N/A

Biofeedback Enhanced Treatment (Behavioral Intervention) 2023 Treatment Timeline for Medical Study. Trial Name: NCT05202418 — N/A

Inflammatory Bowel Disease Research Study Groups: Wait-list control, Biofeedback Enhanced Treatment

Inflammatory Bowel Disease Clinical Trial 2023: Biofeedback Enhanced Treatment Highlights & Side Effects. Trial Name: NCT05202418 — N/A

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

What are the major goals of this medical research?

"This trial will be assessing the efficacy of a new treatment over 6 weeks and 2 months post-treatment. The primary outcome evaluated is changes in retention rate, with secondary outcomes including alterations to children's anxiety scores (SCARED), depression levels (CDI-2) and clinical symptoms(CSSI). An estimation of mediation effect will also be conducted by comparing regression coefficient values."

Answered by AI

Does this trial allow participation from those below the age of 70?

"This clinical trial stipulates that the youngest participants may be 13 years of age and the oldest 18."

Answered by AI

What are the requirements for participation in this clinical trial?

"This clinical trial seeks 40 minors (ages 13-18) with a confirmed diagnosis of inflammatory bowel diseases. In order to qualify, the patient must be able to speak English and have at least one parent/guardian willing to participate in the study along with them; additionally, they need to pass a depression or anxiety symptom screen using either PHQ-9 or PROMIS Pediatric Anxiety measures."

Answered by AI

Are any volunteers currently being sought for this clinical trial?

"Clinicaltrials.gov indicates that the recruitment process for this medical trial has started and is ongoing. The study was first made public on February 27th 2022, with changes most recently being implemented at the end of March 2021."

Answered by AI

What is the current intake capacity of this research program?

"Affirmative. The information on clinicaltrials.gov indicates that this medical experiment is actively enrolling participants, having been initially posted on February 27th 2022 and recently updated on March 28th 2022. Forty patients must be enrolled from 3 distinct healthcare facilities."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

Stress in Inflammatory Bowel Disease

Bonney Reed 2022. "Stress in Inflammatory Bowel Disease". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT05202418.