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

Launched by NORTHWESTERN UNIVERSITY · Jul 9, 2021

Keywords

ClinConnect Summary

OVERVIEW: In this randomized, sham-controlled phase II/III adaptive trial, we will randomize 250 subjects with symptoms of GERD to eCBT+ (esophageal Cognitive Behavioral Therapy) or sham-SOC (Standard of Care) Lifestyle Coaching. Each subject will receive 6 sessions of 45 minutes each delivered by telehealth. The study will be conducted at two institutions: Northwestern University and Washington University. The interventions will be delivered by GI Health psychologists based at Northwestern University.

RANDOMIZATION AND BLINDING: Participants will be blinded as to the intervention they wil...

Gender

ALL

Eligibility criteria

• Inclusion Criteria:
• • Male or female subjects (females of childbearing potential should be on highly effective contraceptive methods)
• • Aged 18-80 years old
• • Mentally capable to provide informed consent
• • Fluent in English
• • Have symptoms of GERD (heartburn, regurgitation, and non-cardiac chest pain)
• • Have failed an appropriate compliant trial of PPI therapy with a GERDQ score ≥6.
• • Able to undergo endoscopy, ambulatory reflux monitoring, and manometry
• • Be interested in behavioral interventions for ongoing symptoms.
• Exclusion Criteria:
• • Participation in a concurrent clinical trial or completed another trial within past 8 weeks.
• • Active severe erosive esophagitis (Los Angeles Grade C or D), Long segment Barrett's esophagus (Zap score of 4)
• • Prior gastrointestinal surgery of the esophagus and/or stomach
• • Current signs or symptoms of heart disease. All patients with non-cardiac chest pain are required to have a cardiologist evaluation as standard of care work up in the evaluation of non-cardiac chest pain.
• • Unstable medical illness with ongoing diagnostic work-up and treatment. Patients with well-controlled hypertension, diabetes and a remote history of ischemic heart disease that is deemed stable, as judged by the investigator can be included.
• • History of drug addiction, drug abuse or alcoholism.
• • Current neurologic or cognitive impairment, which would preclude ability to obtain informed consent.
• • Pregnant patients.
• • Special vulnerable populations including children, prisoners, institutionalized individuals.
• • Bleeding disorder or requirement of NSAID/aspirin during monitoring period.
• • Drugs that affect gastrointestinal symptoms (H2 blockers, antacids, metoclopramide, domperidone, erythromycin, anticholinergics \[bentyl, levsin, belladonna etc.\]). Antidepressants can be continued at stable dose.
• • Patients found to have achalasia, a spastic disorder, hypercontractile disorder or functional obstruction at the esophagogastric junction will be excluded