Treatment of Upper Gastrointestinal Symptoms Using Hypnotherapy Sessions

Mayo Clinic

Status: Enrolling

Conditions: GI Symptoms

Treatments: Behavioral: Educational module; Behavioral: Hypnotherapy

Study type: Interventional

Funder types: Other

Identifiers

NCT06846359

24-007628

Details and patient eligibility

About

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

Full 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 and after being randomized.

The whole study will last for 24 weeks: the initial 12-week treatment period and then an additional 12-week follow-up period

Enrollment: 100 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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 previously undergone test of gastric emptying of solids using the standardized Mayo Clinic scintigraphic method (4h 320kcal egg, 30% fat meal) and will have <25% retained at 4 hours to meet inclusion criteria. Patients with current untreated H. pylori infection will be excluded.
• 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.
• 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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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100 participants in 2 patient groups

Hypnotherapy

Experimental group

Description:

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

Treatment:

Behavioral: Hypnotherapy

Educational module

Other group

Description:

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

Treatment:

Behavioral: Educational module