NCT04960566

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

ENROLLING BY INVITATION NA Last updated 11 August 2025

What this trial tests

NA trial testing Cognitive Behavioral Therapy in Gastroesophageal Reflux in 250 participants. Enrolling by invitation.

Timeline

19 April 2022

Primary endpoint
31 May 2026

30 November 2026

Quick facts

Lead sponsor	Northwestern University
Phase	NA
Status	ENROLLING BY INVITATION
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	double
Primary purpose	treatment
Enrollment	250
Start date	19 April 2022
Primary completion	31 May 2026
Estimated completion	30 November 2026
Sites	2 locations across United States

Drugs / interventions tested

• Cognitive Behavioral Therapy
• Sham-SOC Lifestyle Coaching

Conditions studied

• Gastroesophageal Reflux — all drugs for Gastroesophageal Reflux →

Sponsor

Northwestern University

Who can join

Adults 18 to 80, any sex, with Gastroesophageal Reflux. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

GERD affects roughly 20% of the U.S. population and the direct and indirect costs of GERD are substantial, totaling close to 50 billion dollars per year. Evidence supports that a large proportion of this cost and poor clinical outcomes in GERD are related to poor healthcare decisions by both the physician and the patient. The problem of inappropriate GERD management stems from three main issues. First, the disease is heterogeneous and requires treatment informed by a precision model. Second, the current paradigm largely ignores the important brain-gut interactions that drive symptoms and healthcare utilization. Third, there is a paucity of well-performed comparative effectiveness trials focused on assessing treatments beyond acid suppression. We will use physiomarkers defined during the previous funding cycle to phenotype the patients and use cognitive behavioral interventions to modulate hypervigilance to test the Psycho-Physiologic Model of GERD. Cognitive Behavioral Therapy (CBT) is able to improve hypervigilance and symptom specific autonomic arousal and thus, we will test our theory that CBT can improve outcomes in GERD by targeting these two important psychologic stressors. We will also continue our focus on the interplay of psychology and physiology by determining whether increased mucosal permeability is associated with reflux perception and whether this is modified by hypervigilance and autonomic disruption.

Publications & conference data

1 peer-reviewed publication reference this trial (live from Europe PMC):

1. Systematic mapping of registered interventional studies addressing the top 10 research priorities in Barrett's oesophagus and gastro-oesophageal reflux disease.
   Gamakaranage C, Ratcliffe E, Britton J, Butler T, et al · · 2025 · PMID 40527525 · DOI 10.1136/bmjgast-2025-001738