Recruiting

Inflammatory Bowel Disease

Sponsor:

Emory University

Code:

NCT06537258

Conditions

Inflammatory Bowel Diseases

Eligibility Criteria

Sex: All

Age: 13 - 18

Healthy Volunteers: Not accepted

Interventions

Biofeedback Enhanced Treatment

Study Details

Brief 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.

Conditions

Inflammatory Bowel Diseases

Study ID

NCT06537258

Start date

Feb 6, 2025

Status verified date

Mar, 2026

Completion date

Oct, 2028

Anticipated

Primary completion date

Oct, 2028

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 13 - 18

Healthy Volunteers: Not accepted

Inclusion Criteria:

  • 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)

Exclusion Criteria:

  • previous diagnosis of developmental disabilities that require full-time special education or that impair the ability to respond to treatment,
  • diagnosis with any other chronic disease (e.g., diabetes, epilepsy, etc.),
  • diagnosis of abnormal thyroid function,
  • treatment with any drug with known autonomic cardiovascular influences including beta-blockers, central sympatholytic agents, or antidepressants.

Study Design

Enrollment

128 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Supportive Care

Interventions and Outcome Measures

Arms

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).

Interventions

Biofeedback Enhanced Treatment

At all 4 assessment points (T1-T4), HRV will be measured using the ECG module of the mobile MindWare system at a sampling rate of 500 Hz, and a Skin Conductance Response (SCR) will be collected at a sampling rate of 10 Hz using eSense for iPad. Electrodes to assess SCR and HRV will be attached to patients during an \~10-minute period.

A 5-minute initial baseline assessment will occur first followed by three 5-minute stress trials.

Stress tasks will be audio recorded to measure study fidelity, and participants will be asked to rate their subjective level of stress with each trial. At all assessment points (T1-T4), participants will be provided with stool collection kits to collect a stool sample within 3 days of the laboratory psychophysiological assessment.

At all assessment points (T1-T4), a blood draw of approximately 3 ml of blood will be collected.

Primary outcome measure

  • Changes in psychological distress [ Time Frame: Baseline, 6 weeks post-intervention ]

Central Contacts and Locations

Central contacts

Bonney Reed, PhD

404-727-8312ebreed@emory.edu

Locations

Atlanta Metropolitan Area

Recruiting

Atlanta, Georgia, United States, 30303

Contacts

Bonney Reed, PhD

ebreed@emory.edu

Children's Healthcare of Atlanta

Recruiting

Atlanta, Georgia, United States, 30322

Contacts

Bonney Reed, PhD

ebreed@emory.edu

Principal Investigator:

Bonney Reed, PhD

Center for Advanced Pediatrics

Recruiting

Atlanta, Georgia, United States, 30329

Contacts

Bonney Reed, PhD

ebreed@emory.edu

Principal Investigator:

Bonney Reed, PhD

More Information

Sponsor

Emory University

Last update posted

Apr 1, 2026

Last verified

Mar, 2026

Keywords

  • cognitive behavioral therapy
  • heart rate variability

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Emory University on 2026-04-01.