RecruitingNot ApplicableNCT06939465

Cognitive-behavioral Therapy for the Diseases Associated With Esophageal-brain-gut Axis Communication Abnormalities.

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


Sponsor

Hualien Tzu Chi General Hospital

Enrollment

120 participants

Start Date

Apr 2, 2024

Study Type

INTERVENTIONAL

Conditions

Summary

Gastroesophageal reflux disease (GERD) is a challenging gastrointestinal disorder, and proton pump inhibitors (PPIs) are typically the first line of treatment. However, up to 40% of GERD patients experience little to no relief or only partial relief of their symptoms after receiving PPI therapy. Among these patients, who do not respond to high-dose PPIs taken twice daily, more than 90% exhibit conditions related to brain-gut axis communication disorders, such as esophageal hypersensitivity and functional heartburn. Visceral hypersensitivity and esophageal hypervigilance are the two key causes of esophageal symptoms in this group of patients. According to the Rome IV consensus on esophageal disorders, five categories are identified: functional chest pain, functional heartburn, globus sensation, functional dysphagia, and esophageal hypersensitivity. The diagnostic criteria state that patients must have chronic esophageal symptoms, and any structural, inflammatory, or motility abnormalities must be excluded. Therefore, diagnosing brain-gut axis communication disorders in the esophagus requires upper gastrointestinal endoscopy, esophageal pH-impedance testing, and high-resolution esophageal manometry. Neuromodulators, which regulate peripheral and central pain sensitivity, are a cornerstone of pharmacological treatment for brain-gut axis communication disorders and associated symptoms. Additionally, growing evidence supports the use of brain-gut axis behavioral therapies, such as gut-directed hypnotherapy and cognitive behavioral therapy (CBT), to effectively treat these disorders. However, research on neuromodulators and CBT in brain-gut axis communication disorders remains limited, and their efficacy is still unclear. The aim of this study is to investigate the effectiveness and role of CBT in treating brain-gut axis communication disorders. The information gained from this research will help clarify the pathophysiological mechanisms related to brain-gut axis communication abnormalities and refractory GERD symptoms. Furthermore, the findings will guide the development of effective treatment strategies for patients with brain-gut axis communication disorders who do not respond to PPI therapy in clinical practice.


Eligibility

Min Age: 18 YearsMax Age: 75 Years

Inclusion Criteria2

  • Age between 18 and 75 years, with clear consciousness and willingness to sign the informed consent form.
  • 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 Criteria12

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

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Interventions

BEHAVIORALCognitive Behavioral Therapy (CBT)

The participants will undergo a 6-week cognitive behavioral therapy (CBT) guided by a psychologist, with one session per week, each lasting 1 hour.

BEHAVIORALLifestyle management (sham control)

The participants will undergo a 6-week lifestyle management (sham control) guided by a psychologist, with one session per week, each lasting 1 hour.


Locations(1)

Hualien Tzu Chi Hospital,Buddhist Tzu Chi Medical Foundation

Hualien City, Taiwan

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NCT06939465


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