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Retraining the brain to quiet the gut: CBT takes on reflux that drugs can't fix

NCT ID NCT06939465

Symptom relief Sponsor: Hualien Tzu Chi General Hospital Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now This study
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Sep 08, 2026 · Last updated Sep 09, 2026 · Updated 1 time

Summary

Many people with acid reflux still feel heartburn or chest discomfort even after taking strong acid-suppressing drugs. Researchers suspect the problem lies in the brain-gut connection, where the esophagus becomes overly sensitive and the mind stays on high alert for symptoms. This trial tests whether six weeks of cognitive behavioral therapy, guided by a psychologist, can reduce those symptoms better than standard lifestyle advice. The study enrolls adults aged 18 to 75 with chronic esophageal symptoms linked to gut-brain disorders, and measures changes through questionnaires and heart rate variability.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
Cognitive behavioral therapy (CBT) delivered by a psychologist over 6 weeks
What this could lead to
If CBT works, it could offer a drug-free way to ease persistent reflux symptoms in people who do not respond to standard acid-reducing medications.
What could go wrong
This is a relatively small trial, and CBT may not outperform lifestyle management. Success depends on participants engaging fully with therapy sessions.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Not a phased trial

Phase numbers describe drug development. The registry uses this when they do not apply, as it does for trials of devices, procedures or behaviour changes, and for observational studies.

Participants

About 120 people

The number the study aims to enrol. It can still change while the study runs.

Started

Apr 2024

Expected to finish

Dec 2026

An estimate. End dates often move.

Lead sponsor

Other sponsor

The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

18 to 75 years

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

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.

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Conditions

The condition(s) this trial relates to.

gastroesophageal reflux disease

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

GERD without erosive esophagitis Gut-brain disorders

How to take part

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  1. The places running it

    1 site. The list below names each one and where it is.

  2. The official record

    ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.

    Open the record ↗

  3. A doctor treating you

    A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.

Contacts and locations

Locations

  • Hualien Tzu Chi Hospital,Buddhist Tzu Chi Medical Foundation

    RECRUITING

    Hualien City, Taiwan

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