Cognitive Behavioral Therapy for Acid Reflux

Recruiting in Palo Alto (17 mi)

+2 other locations

Overseen byJohn E Pandolfino, MD

Age: 18+

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Academic

Waitlist Available

Sponsor: Northwestern University

No Placebo Group

Approved in 4 Jurisdictions

Trial Summary

What is the purpose of this trial?This trial tests a new therapy called eCBT+ for patients with GERD who don't respond well to usual treatments. The therapy helps reduce stress and focus on symptoms by changing how patients think and behave. The goal is to see if this approach can improve their quality of life.

Eligibility Criteria

This trial is for adults aged 18-80 with GERD symptoms who haven't improved after acid blocker therapy. They must be fluent in English, able to undergo specific digestive system tests, and interested in behavioral treatment. Excluded are those with severe esophagitis, certain esophageal conditions or surgeries, unstable illnesses, drug/alcohol abuse history, cognitive impairments, pregnancy, or taking medications affecting GI symptoms.

Inclusion Criteria

I can have procedures to check my digestive health.

I am between 18 and 80 years old.

I understand the information given to me and can make decisions about my health care.

+5 more

Exclusion Criteria

Pregnant patients

My other illnesses are stable, and I am not currently undergoing any major medical investigations.

I have symptoms of heart disease or non-cardiac chest pain.

+9 more

Participant Groups

The study examines if Cognitive Behavioral Therapy (CBT) can improve GERD by reducing hypervigilance and autonomic arousal—body's stress responses. It compares CBT's effectiveness against a sham intervention that mimics standard lifestyle coaching but doesn't address these psychological factors.

2Treatment groups

Experimental Treatment

Placebo Group

Group I: eCBT+Experimental Treatment1 Intervention

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).

Group II: Sham-SOC Lifestyle CoachingPlacebo Group1 Intervention

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.

Cognitive Behavioral Therapy is already approved in European Union, United States, Canada, Australia for the following indications:

🇪🇺 Approved in European Union as Cognitive Behavioral Therapy for: