What is the mechanism of action of this treatment?

The most common treatments for Inflammatory Bowel Disease (IBD) include 5-aminosalicylic acid (5-ASA) agents, corticosteroids, immunomodulators, and biologics. 5-ASA agents, such as mesalamine, reduce inflammation in the lining of the intestines by inhibiting the production of inflammatory chemicals. Corticosteroids, like prednisone, suppress the overall immune response to quickly reduce inflammation but are typically used short-term due to side effects. Immunomodulators, such as azathioprine, alter the immune system's activity to prevent ongoing inflammation. Biologics, including infliximab, target specific proteins involved in the inflammatory process, providing a more targeted approach to reducing inflammation. Understanding these mechanisms is crucial for IBD patients as it helps tailor treatment plans to effectively manage symptoms, reduce flare-ups, and improve quality of life.

What side effects are associated with this type of intervention?

Common treatments for Inflammatory Bowel Disease (IBD) include 5-aminosalicylic acid (5-ASA) agents, glucocorticoids, and biologic agents. 5-ASA agents, such as mesalamine and sulfasalazine, can cause side effects like nausea, headache, fever, rash, and, less commonly, pancreatitis and pneumonitis. Glucocorticoids, such as prednisone, are associated with side effects including weight gain, hypertension, diabetes, osteoporosis, and increased risk of infections. Biologic agents, particularly anti-TNF therapies like infliximab and adalimumab, can lead to infusion reactions, increased susceptibility to infections, and rare but serious conditions like hepatosplenic T-cell lymphoma. These side effects are important to consider in the context of psychophysiological and psychological assessments in IBD patients.

What prior FDA approvals exist?

The FDA has approved several biologic agents and immunomodulators for the treatment of Inflammatory Bowel Disease (IBD), including ulcerative colitis and Crohn's disease. Notable biologics include infliximab and adalimumab, which are anti-TNF agents used to reduce inflammation. Vedolizumab, another biologic, targets gut-specific integrins to control inflammation. Immunomodulators like azathioprine and 6-mercaptopurine are also approved and used to maintain remission in IBD patients. These treatments aim to manage symptoms and induce mucosal healing, aligning with the goals of the trial assessing psychophysiological and psychological parameters in IBD patients.

What other types of research exist?

Promising, novel alternatives to the assessment-based approach for IBD patients in 2024 include biologic therapies (e.g., anti-TNF, anti-IL 12/23, anti-integrin), personalized medicine approaches, and integrative therapies such as nutritional interventions and mind-body therapies.

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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

Must not have

Parent is unwilling to participate.

Timeline

Screening 3 weeks

Treatment Varies

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

Awards & highlights

No Placebo-Only Group

Summary

This trial tests if teaching stress management and using biofeedback can help young people with newly diagnosed IBD reduce anxiety, depression, and disease symptoms.

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.

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.

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

Select...

I am between 8 and 17 years old.

Select...

I have been diagnosed with IBD through a biopsy.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

Select...

My parent is not willing to participate.

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

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Changes in the retention rate

Changes in treatment satisfaction

Secondary study objectives

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

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

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 / 3Eligibility criteria met

Research Highlights

Information in this section is not a recommendation. We encourage patients to speak with their healthcare team when evaluating any treatment decision.

Mechanism Of Action

Side Effect Profile

Prior Approvals

Other Research

The most common treatments for Inflammatory Bowel Disease (IBD) include 5-aminosalicylic acid (5-ASA) agents, corticosteroids, immunomodulators, and biologics. 5-ASA agents, such as mesalamine, reduce inflammation in the lining of the intestines by inhibiting the production of inflammatory chemicals. Corticosteroids, like prednisone, suppress the overall immune response to quickly reduce inflammation but are typically used short-term due to side effects. Immunomodulators, such as azathioprine, alter the immune system's activity to prevent ongoing inflammation. Biologics, including infliximab, target specific proteins involved in the inflammatory process, providing a more targeted approach to reducing inflammation. Understanding these mechanisms is crucial for IBD patients as it helps tailor treatment plans to effectively manage symptoms, reduce flare-ups, and improve quality of life.

Clinical communication in inflammatory bowel disease: a systematic review of the study of clinician-patient dialogue to inform research and practice.The future of IBD treatment.