What side effects are associated with this type of intervention?

Common treatments for acid reflux include proton pump inhibitors (PPIs) and H2 receptor antagonists (H2RAs). PPIs can cause side effects such as headache, diarrhea, constipation, nausea, and potential long-term risks like vitamin B12 deficiency and bone fractures. H2RAs may lead to headaches, dizziness, diarrhea, and constipation. Cognitive Behavioral Therapy (CBT), used to modulate hypervigilance and autonomic arousal, generally has fewer physical side effects but may initially cause increased anxiety or emotional discomfort as patients confront their symptoms. Overall, CBT is considered safe and effective for managing psychological aspects of acid reflux.

What prior FDA approvals exist?

The FDA has approved several classes of drugs for the treatment of acid reflux, including proton pump inhibitors (PPIs) like omeprazole and esomeprazole, and H2 receptor antagonists (H2RAs) such as ranitidine and famotidine. These medications work by reducing stomach acid production. While Cognitive Behavioral Therapy (CBT) is being studied for its potential to modulate hypervigilance and symptom-specific autonomic arousal in GERD, it is not an FDA-approved treatment for acid reflux. Instead, CBT is recognized for its benefits in managing psychological aspects of chronic conditions, which may indirectly improve GERD symptoms.

What other types of research exist?

Promising novel alternatives to CBT for acid reflux patients include antireflux ablation therapy (ARAT), clip band ligation anti-reflux therapy (C-BLART), and transcutaneous electrical acustimulation. These treatments have shown potential in recent studies for managing GERD symptoms and improving quality of life.

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Cognitive Behavioral Therapy for Acid Reflux

N/A

Waitlist Available

Led By John E Pandolfino, MD

Research Sponsored by Northwestern University

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Able to undergo endoscopy, ambulatory reflux monitoring, and manometry

Aged 18-80 years old

Must not have

Bleeding disorder or requirement of NSAID/aspirin during monitoring period

Current neurologic or cognitive impairment, which would preclude ability to obtain informed consent

Timeline

Screening 3 weeks

Treatment Varies

Follow Up week 25

Summary

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.

Who is the study for?

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.

What is being tested?

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.

What are the potential side effects?

Since the interventions involve therapy and coaching rather than medication or invasive procedures, side effects may include discomfort from discussing personal issues during sessions or potential frustration if no improvement in GERD symptoms is perceived.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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I can have procedures to check my digestive health.

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I am between 18 and 80 years old.

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

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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I have a bleeding disorder or need NSAID/aspirin.

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I do not have any brain or thinking problems that would stop me from understanding a consent form.

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I have severe acid damage in my esophagus or a long area of precancerous changes.

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I have had surgery on my esophagus or stomach before.

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I do not have a swallowing disorder or blockage at the junction of my esophagus and stomach.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ week 25

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~week 25

This trial's timeline: 3 weeks for screening, Varies for treatment, and week 25 for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

EHAS

Esophageal Permeability

GERD PROMIS

+4 more

Secondary study objectives

Client Satisfaction Questionnaire - 8

Sessions completed

Side effects data

From 2021 Phase 4 trial • 12 Patients • NCT04135937

irritability

100%

80%

60%

40%

20%

Study treatment Arm

MESH

Trial Design

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.

0 / 8Eligibility criteria met

Research Highlights

Information in this section is not a recommendation. We encourage patients to speak with their healthcare team when evaluating any treatment decision.

Mechanism Of Action

Side Effect Profile

Prior Approvals

Other Research

Common treatments for acid reflux include proton pump inhibitors (PPIs) and H2 receptor antagonists (H2RAs), which reduce stomach acid production, and lifestyle modifications such as weight loss and elevating the head of the bed to prevent reflux. Cognitive-behavioral therapy (CBT) is also being studied for its potential to modulate hypervigilance and symptom-specific autonomic arousal, which are psychological factors that can exacerbate reflux symptoms. By addressing both the physiological and psychological components of acid reflux, these treatments aim to provide comprehensive symptom relief and improve the quality of life for patients.

Functional heartburn: the stimulus, the pain, and the brain.