Targeting Hypervigilance and Autonomic Arousal: the Psycho-physiologic Model of Gastroesophageal Reflux Disease (GERD)

NAEnrolling by invitationINTERVENTIONAL
Enrollment

250

Participants

Timeline

Start Date

April 19, 2022

Primary Completion Date

May 31, 2026

Study Completion Date

November 30, 2026

Conditions
Gastroesophageal Reflux
Interventions
OTHER

Cognitive Behavioral Therapy

The CBT intervention is based on the theoretical framework that under stress (reflux symptoms) a person makes a rapid cognitive appraisal of the potential threat (automatic thoughts), leading to both emotional and physical responses in the body, thereby reacting behaviorally (avoidance, increased HCU) in an attempt to mitigate unpleasantness. CBT is a collaborative, present-focused treatment that utilizes a skills-based approach with home practice exercises. CBT targets automatic thoughts and appraisals of threat via education, self-monitoring of stressors and symptoms, and strategies to reframe problematic thinking patterns to more adaptive ones. Resonance frequency breathing (RFB) is achieved when a person breathes at a pace, typically 4 to 6 breaths per minute, that engages the body's baroreflex to modulate arousal. Prior research demonstrates 4 to 6 weeks of RFB training is sufficient to significantly increase baseline HRV with enduring effects for up to 6 months.

OTHER

Sham-SOC Lifestyle Coaching

Sham-SOC Lifestyle Coaching

Trial Locations (2)

60611

Northwestern University, Chicago

63110

Washington University, St Louis

All Listed Sponsors
collaborator

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

NIH

collaborator

Washington University School of Medicine

OTHER

collaborator

University of California, San Diego

OTHER

collaborator

Vanderbilt University School of Medicine

OTHER

lead

Northwestern University

OTHER