Targeting Hypervigilance and Autonomic Arousal: the Psycho-physiologic Model of Gastroesophageal Reflux Disease (GERD)
Gastroesophageal Reflux
About this trial
This is an interventional treatment trial for Gastroesophageal Reflux
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
Sites / Locations
- Northwestern University
- Washington University
Arms of the Study
Arm 1
Arm 2
Experimental
Sham Comparator
eCBT+
Sham-SOC Lifestyle Coaching
eCBT+ participants will be enrolled in 6, 45-minute sessions delivered via a secure video platform with a GI psychologist. To reinforce concepts reviewed in the sessions, participants will complete weekly home practice exercises. The targets are 1) improved maladaptive cognitive-affective processes associated with increased hypervigilance and symptom anxiety, 2) reduced behaviors associated with EHA including avoidance, increased medication/healthcare utilization and 3) reduced autonomic nervous system (ANS) arousal by increased HRV. Participants will learn to identify, question, and modify maladaptive thoughts, beliefs, and assumptions related to their symptoms (symptom anxiety). Systematic exposure to feared events are used to reduce maladaptive coping strategies (hypervigilance, PPI overuse, HCU). Specific, paced diaphragmatic breathing exercises (Resonance Frequency Breathing) designed to increase HRV are the last component (visceral hypersensitivity, reflux physiology).
Patients randomized to the SOC condition will receive lifestyle guidance recommended for patients with GERD over a period of 6, 45-minute sessions with the GI psychologist to maintain consistency of delivery between the two intervention arms. Topics include maintaining a healthy weight, identifying triggering food and drink, making healthy food choices, eating behaviors, smoking and/or alcohol use, and timing of meals. The SOC condition will be carefully designed to not include any principles of the eCBT+ condition rather be based solely on patient education and encouragement to practice lifestyle changes on their own.