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A Heart Rate Variability Biofeedback Enhanced Behavioral Intervention to Improve Psychological and Disease Functioning in Youth With Inflammatory Bowel Disease (IBD)

Status: Recruiting
Location: See all (3) locations...
Intervention Type: Behavioral
Study Type: Interventional
Study Phase: Not Applicable
SUMMARY

The goals of this study are to test the effectiveness of a virtually delivered, group-based coping skills treatment program incorporating heart rate variability biofeedback to target autonomic dysfunction in youth diagnosed with inflammatory bowel disease (IBD). The investigators will enroll participants with IBD in a biofeedback enhanced cognitive behaviorally based coping skills treatment. Participants will be randomized to biofeedback enhanced treatment or wait-list control.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 13
Maximum Age: 18
Healthy Volunteers: f
View:

• Diagnosis with biopsy-confirmed IBD for at least 4 months,

• ages 13 through 18 years inclusive,

• speak English,

• enrolling with at least 1 parent/guardian who is willing to participate by completing surveys,

• positive depression or anxiety screens using the PHQ-4, - access to home internet to participate in virtual intervention,

• youth and parent agree to the conditions of study participation, including randomization, participation in intervention, and follow-up assessments,

• youth is medically approved to engage in normal daily activities (e.g., attend school, extracurricular activities)

Locations
United States
Georgia
Atlanta Metropolitan Area
RECRUITING
Atlanta
Center for Advanced Pediatrics
RECRUITING
Atlanta
Children's Healthcare of Atlanta
RECRUITING
Atlanta
Contact Information
Primary
Bonney Reed, PhD
ebreed@emory.edu
404-727-8312
Time Frame
Start Date: 2025-02-06
Estimated Completion Date: 2028-10
Participants
Target number of participants: 128
Treatments
Experimental: Biofeedback Enhanced Treatment
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. Groups will meet approximately each week for 6 weeks. Patients will also rate their disease symptoms and measures of clinical disease activity will be collected via chart review. Clinical assessments will occur at baseline within 1 week prior to starting treatment (T1), at treatment end or 6 weeks after baseline (T2), 14 weeks after baseline to capture 2-month follow-up after treatment (T3) and at 26 weeks after baseline (T4).
No_intervention: Wait-list control
Participants randomized to the waitlist control group will complete the same assessment protocol at the time of randomization (Baseline) and again 6 weeks later. They will then be invited to begin treatment and will repeat the assessments at posttest and again at 14 and 26-week follow-up (for a total of 5 assessments).
Related Therapeutic Areas
Sponsors
Collaborators: National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
Leads: Emory University

This content was sourced from clinicaltrials.gov