RecruitingNot ApplicableNCT06846359

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.


Sponsor

Mayo Clinic

Enrollment

100 participants

Start Date

Feb 20, 2025

Study Type

INTERVENTIONAL

Conditions

Summary

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


Eligibility

Min Age: 18 Years

Inclusion Criteria8

  • Patients will meet criteria for at least one upper GI DGBI including functional dyspepsia, any nausea/vomiting disorder, or functional abdominal bloating. Lower GI DGBIs, such as IBS, are allowable if the primary symptom is either an upper GI symptom or bloating/distension.
  • Participants will have had a negative 4-hour solid food gastric emptying test previously or a normal C13 Breath test at screening.
  • Patients with known disaccharide intolerances may be included if dietary restrictions are maintained during the duration of the study.
  • Patients utilizing cannabinoid based substances may be included if no dose changes are made during the duration of the study
  • Patients will be proficient in English language for comprehension of content
  • Patients will have reliable access to digital delivery systems for content and questionnaire access via smartphone over the course of the study and follow up period.
  • Stable doses medications are permissible, but dosing should not be changed during study period.
  • Patients who are pregnant.

Exclusion Criteria7

  • Patients with known current diagnosis of small intestinal bacterial overgrowth (SIBO), gastroparesis, rumination syndrome, chronic intestinal pseudo-obstruction, advanced connective tissue diseases (e.g. scleroderma), and uncontrolled inflammatory bowel disease (IBD) will be excluded.
  • Patients with current untreated H. pylori infection will be excluded.
  • In patients with predominant bloating symptoms and constipation, those with untreated pelvic floor dysfunction will be excluded. If the predominant symptoms are nausea/vomiting or dyspepsia, or if constipation is not present, then pelvic floor dysfunction will not be exclusionary.
  • Patients who have a history of cognitive delay, traumatic brain injury with residual deficits, history of cerebral vascular accident with residual deficiencies in cognition, dementia, shall be excluded
  • Patients with significant psychiatric illness with component of psychosis (schizophrenia, bipolar disorder), as well as severe untreated major depressive disorder with suicidal ideation will be excluded
  • Patients with substance abuse disorders and drug addiction will be excluded.
  • Patients who are unlikely to comply or unlikely to benefit from psychotherapy-based interventions may be excluded at the direction of medical screening provider or principal investigator.

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Interventions

BEHAVIORALHypnotherapy

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.

BEHAVIORALEducational module

self-guided online module reviewing chronic GI conditions, pathophysiology, and alternative treatment options.


Locations(1)

Mayo Clinic

Rochester, Minnesota, United States

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NCT06846359