NCT06846359

Treatment of Upper Gastrointestinal Symptoms Using Hypnotherapy Sessions

The Impact Of Gastric Phenotyping In Predicting And Assessing The Clinical Success Of Gut-Directed Hypnotherapy For Patients With Gastroduodenal DGBIS.

• Status: Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 100 (estimated)
• Sponsor: Mayo Clinic · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

The purpose of this research is to evaluate if hypnotherapy delivered digitally will help your GI symptoms.

Detailed description

This study will assess the effects of digitally delivered hypnotherapy sessions n those with upper GI symptoms. There are 2 therapy arms: Hypnotherapy treatment over 3 months or control arm with an educational module. The hypnotherapy treatment consists of seven pre-recorded hypnotherapy sessions that will be digitally delivered to patients on their own electronic devices via an existing digital platform provided by metaMe Health. metaMe Health is a company specialized in the delivery of digital hypnotherapy protocols. The sessions will be delivered to patients over twelve weeks in accordance with current gut-direct hypnotherapy practice. The patients must agree to have their consent and content delivered electronically and provide periodic outcomes by completing electronic symptom questionnaires. Both arms will also complete C13 breath test and gastric alimetry testing before being randomized. Participants will have the option to complete an optional breath test at the end of the 12 weeks. The whole study will last for 24 weeks: the initial 12-week treatment period and then an additional 12-week follow-up period

Conditions

• GI Symptoms

Interventions

Type	Name	Description
BEHAVIORAL	Hypnotherapy	Seven pre-recorded hypnotherapy sessions delivered over the course of twelve weeks via the patient's own electronic device such as a smartphone, tablet, or laptop. The length of the audio-recorded treatment sessions is expected to be approximately 40 minutes on average.
BEHAVIORAL	Educational module	self-guided online module reviewing chronic GI conditions, pathophysiology, and alternative treatment options.

Timeline

• Start date: 2025-02-20
• Primary completion: 2027-01-01
• Completion: 2027-02-01
• First posted: 2025-02-26
• Last updated: 2026-03-04

Locations

1 site across 1 country: United States