Recruiting

HypnotherapyTreatment of Upper Gastrointestinal Symptoms Using Hypnotherapy Sessions

Sponsor:

Mayo Clinic

Code:

NCT06846359

Conditions

GI Symptoms

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Interventions

Hypnotherapy

Educational module

Study Details

Brief summary:

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

Conditions

GI Symptoms

Study ID

NCT06846359

Start date

Feb 20, 2025

Status verified date

Feb, 2026

Completion date

Feb 1, 2027

Anticipated

Primary completion date

Jan 1, 2027

Anticipated

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Inclusion criteria:

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.

Exclusion criteria:

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.
Standard inclusion criteria will include: ability to provide informed consent, absence of other diseases (structural or metabolic) which could interfere with interpretation of the study results.
Stable doses medications are permissible, but dosing should not be changed during study period.
Patients who are pregnant.

Study Design

Enrollment

100 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

experimental: Hypnotherapy

7 pre-recorded hypnotherapy sessions delivered over 12 weeks via patient's own electronic device. Sessions are approximately 40 minutes long.

other: Educational module

Patient's will be given a link to a educational module that reviews chronic GI conditions, pathophysiology, and alternative treatment options.

Interventions

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.

Educational module

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

Primary outcome measure

Change in Irritable Bowel Symptom Severity Index (IBS-SSS) score [ Time Frame: Baseline, 12 weeks, 24 weeks ]
Change in Patient Assessment of Upper Gastrointestinal Disorders Symptom Severity Index (PAGI-SYM) score [ Time Frame: Baseline, 12 weeks, 24 weeks ]

Central Contacts and Locations

Central contacts

Taylor Hines

507-538-9959 Hines.taylor@mayo.edu

Locations

Mayo Clinic

Recruiting

Rochester, Minnesota, United States, 55905

Contacts

Shelly Ward

507-538-9997 Ward.shelly1@mayo.edu

Principal Investigator:

Xiao Jing Wang, MD

More Information

Sponsor

Mayo Clinic

Last update posted

Mar 4, 2026

Last verified

Feb, 2026

Keywords

hypnotherapy
disorders of gut-brain interaction

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Mayo Clinic on 2026-03-04.