Cognitive-behavioral therapy for gut-brain communication issues in GERD patients

Esophageal Visceral Hypersensitivity and Hypervigilance in Disorders of Gut-brain Interaction: the Roles of Cognitive-behavioral Therapy

This study tests if cognitive-behavioral therapy can help people with GERD who don't get better with usual medications by improving how their brain and gut communicate.

Quick facts

• Phase: Not applicable
• Study type: Interventional
• Enrollment: 120 (estimated)
• Ages: 18 Years to 75 Years
• Sex: All
• Sponsor: Hualien Tzu Chi General Hospital (Academic / other)
• Locations: 1 site (Hualien City)
• Trial ID: NCT06939465 on ClinicalTrials.gov

What this trial studies

This study investigates the effectiveness of cognitive-behavioral therapy (CBT) in treating patients with gastroesophageal reflux disease (GERD) who do not respond to standard proton pump inhibitor therapy. Participants will undergo initial assessments, including questionnaires and heart rate variability measurements, followed by a six-week intervention period where they will receive either CBT or lifestyle management as a control. The study aims to evaluate changes in symptoms and physiological responses after the intervention through follow-up assessments. The approach focuses on addressing the underlying brain-gut communication disorders that contribute to GERD symptoms.

Who should consider this trial

Good fit: Ideal candidates are adults aged 18 to 75 with chronic esophageal symptoms related to brain-gut axis communication disorders.

Not a fit: Patients with structural esophageal diseases or significant gastrointestinal motility disorders may not benefit from this study.

Why it matters

Potential benefit: If successful, this therapy could provide significant relief for GERD patients who currently experience inadequate symptom control with conventional treatments.

How similar studies have performed: Previous studies have shown promise in using cognitive-behavioral therapy for similar gut-brain interaction disorders, indicating potential for success in this approach.

Eligibility criteria

Inclusion Criteria:

1. Age between 18 and 75 years, with clear consciousness and willingness to sign the informed consent form.
2. Subjects with chronic esophageal symptoms related to disorders of the brain-gut axis communication (such as heartburn, acid reflux, sensation of a foreign body in the throat, difficulty swallowing, and chest pain or discomfort).

Exclusion Criteria:

1. Esophageal strictures, or history of surgery on the esophagus, gastrointestinal tract, or throat.
2. Structural esophageal diseases (such as diverticula, esophageal rings, etc.), infectious esophagitis, erosive esophagitis, eosinophilic esophagitis.
3. Non-erosive gastroesophageal reflux disease or significant esophageal motility disorders.
4. History of or current diagnosis of malignancies in the esophagus, gastrointestinal tract, or other organs.
5. Significant endocrine or rheumatic immune diseases that may affect gastrointestinal motility.
6. Continuous use of medications that may affect esophageal motility within the past month (such as anticholinergics, opioid-like agents, nitrates, calcium channel blockers, etc.).
7. Use of or currently taking antidepressants, selective serotonin reuptake inhibitors, or other psychotropic medications within the past three months.
8. Pregnant or breastfeeding women.
9. Individuals with mental illness or those who are unable to cooperate.
10. Known allergy to tricyclic antidepressants.
11. Known allergy to selective serotonin reuptake inhibitors.
12. Known allergy to any component of proton pump inhibitors.

Where this trial is running

Hualien City

• Hualien Tzu Chi Hospital,Buddhist Tzu Chi Medical Foundation — Hualien City, Taiwan (Recruiting)

Study contacts

• Study coordinator: Wei-Yi Lei Gastroenterology attending physician

Conditions Gut-Brain Disorders; GERD Without Erosive Esophagitis; gastroesophageal reflux disease; disorders of gut-brain interaction; cognitive behavior therapy