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.

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

Study Overview

• Status: Recruiting
• Conditions: GI Symptoms
• Intervention / Treatment: Behavioral: Hypnotherapy; Behavioral: Educational module

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

• Study Type: Interventional
• Enrollment (Estimated): 100
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Taylor Hines; Phone Number: 507-538-9959; Email: Hines.taylor@mayo.edu

Study Locations

• United States
  • Minnesota
    • Rochester, Minnesota, United States, 55905
      • Recruiting
      • Mayo Clinic
      • Principal Investigator: Xiao Jing Wang, MD
      • Contact: Shelly Ward; Phone Number: 507-538-9997; Email: Ward.shelly1@mayo.edu

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Hypnotherapy; 7 pre-recorded hypnotherapy sessions delivered over 12 weeks via patient's own electronic device. Sessions are approximately 40 minutes long.	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.
Other: Educational module; Patient's will be given a link to a educational module that reviews chronic GI conditions, pathophysiology, and alternative treatment options.	Behavioral: Educational module; self-guided online module reviewing chronic GI conditions, pathophysiology, and alternative treatment options.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change in Irritable Bowel Symptom Severity Index (IBS-SSS) score	The Irritable Bowel Syndrome Symptom Severity Scale (IBS-SSS) is a 5-item questionnaire that rates the severity of abdominal pain, number of days with abdominal pain, distention/bloating, bowel habits, and interference in quality of life. Each question has a possible score of 100 points. The total score can range from 0 - 500, with higher scores indicating greater severity of symptoms.	Baseline, 12 weeks, 24 weeks
Change in Patient Assessment of Upper Gastrointestinal Disorders Symptom Severity Index (PAGI-SYM) score	The Patient Assessment of Upper Gastrointestinal Disorders Symptom Severity Index (PAGI-SYM) is a 20-item questionnaire that rates the severity of upper gastrointestinal symptoms across 6 subscales: heartburn, nausea/vomiting, fullness, bloating, upper abdominal pain, and lower abdominal pain. Subscale scores are calculated by averaging across items comprising the subscale; scores vary from 0 (none or absent) to 5 (very severe).	Baseline, 12 weeks, 24 weeks

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change in Gastroparesis Cardinal Symptom Index (GCSI) score	The Gastroparesis Cardinal Symptom Index (GCSI) is a 9-item questionnaire that assesses the severity of nine gastroparesis symptoms, grouped into three categories: nausea/vomiting, bloating, and postprandial fullness. Each symptom is rated on a scale of 0 (no symptom) to 5 (very severe). The GCSI score is calculated as an average for each category, with higher numbers indicating a greater severity of symptoms.	Baseline, 12 weeks, 24 weeks
Change in abdominal girth		Baseline, 12 weeks
Change in Patient Assessment of Upper Gastrointestinal Disorders-Quality of Life (PAGI-QOL)	The Patient Assessment of Upper Gastrointestinal Disorders-Quality of Life (PAGI-QOL) is a 30-item questionnaire that assesses the quality of life for patients with upper gastrointestinal disorders. Symptom severity is rated on a 6-pointLikert scale with 0 = 'None of the time' and 6 = 'All of the time'. Higher scores indicate a poorer quality of life.	Baseline, 12 weeks, 24 weeks
Change in Work Productivity and Activity Impairment - General Health (WPAI-GH)	The Work Productivity and Activity Impairment - General Health (WPAI-GH) Questionnaire is a 6-item instrument to measure impairments over the past 7 days in both paid work and unpaid work due to one's health.	baseline, 12 weeks, 24 weeks
Patient history files will be audited and included into the analysis to look for contributing clinical information for the development of a clinical decision rule.		End of study analysis, roughly 1 year
Satisfaction with digital delivery platform will be assessed utilizing survey at the end of treatment.		12 weeks
Change in EQ-5D	The EQ-5D (not an abbreviation) is a 5-item questionnaire used to assess quality of life over 5 domains: mobility, self-care, usual activities, pain/discomfort, and anxiety/depression. Questions are rated on a 5-point Likert scale where 0 indicates no interference with daily activities, and 5 indicates inability to perform daily tasks. Higher overall scores indicate a greater degree of difficulty performing daily tasks.	Baseline, 12 weeks, 24 weeks
Change in General Anxiety Disorder 7-item (GAD 7)	The General Anxiety Disorder 7-item (GAD 7) scale to assess severity of generalized anxiety disorder. Scoring is calculated by assigning scores of 0, 1, 2, and 3 to the response categories, respectively, of "not at all," "several days," "more than half the days," and "nearly every day." Total score for the seven items ranges from 0 to 21 where 0 is no anxiety, 1-4 is minimal anxiety, 5-9 is mild anxiety, 10-14 is moderate anxiety, and 15-21 is severe anxiety.	Baseline, 12 weeks, 24 weeks
Change in Perceived Stress Scale (PSS-4)	The 4-item Perceived Stress Scale (PSS) measures global perceived stress experienced by the participant over the preceding 30 days. The questions in this assessment tool ask how often the participant felt or thought a certain way during the past month. Possible answers include: 0 - never; 1 - almost never; 2 - sometimes; 3 - fairly often, and 4 - very often. Possible scores range from 0 to 20, with lower scores indicating a better outcome (less stress).	Baseline, 12 weeks, 24 weeks
Change in Alimetry Gut-Brain Wellbeing Survey (AGBW)	The Alimetry Gut-Brain Wellbeing Survey (AGBW) is a 10-item questionnaire used to assess mental wellbeing in patients with chronic gastroduodenal symptoms. Questions are rated on a 5-point Likert scale, with 0 = 'None of the time' and 5 = 'All of the time'. Higher overall score indicates a greater impact of the patient's gastroduodenal symptoms on their mental wellbeing.	Baseline, 12 weeks, 24 weeks
Change in Brief Illness Perception Questionnaire (BIPQ-R)	The Brief Illness Perception Questionnaire (BIPQ-R) consists of nine items rated on a scale from 0 (minimum) to 10 (maximum). The first five assess cognitive perceptions such as effect on life (item 1); duration of illness (item 2); control over illness (item 3); beliefs about the effectiveness of treatment (item 4); and experience of symptoms (item 5). Items 6 and 8 assess emotional aspects to include concern about illness and a multifaceted question about mood. Item 7 assesses degree of understanding of the illness. The final item is open-ended, asking respondents to rank the three most important factors causing their illness.	Baseline, 12 weeks, 24 weeks
Change in Visceral Sensitivity Index (VSI)	The Visceral Sensitivity Index (VSI) is a 15-item questionnaire used to assess gastrointestinal-specific anxiety. Questions are rated on a 6-point Likert scale, with 0 = 'Strongly Agree' and 6 = 'Strongly Disagree'. Higher score overall indicates a greater degree of anxiety.	Baseline, 12 weeks, 24 weeks
Change in Personal Health Questionnaire Depression Scale (PHQ-9)	The Personal Health Questionnaire Depression Scale (PHQ-9) is an 9-item questionnaire used to assess symptoms of depression over the last 2 weeks. Questions are rated on a 4-point Likert scale with 0 = 'Not at all sure' and 4 = 'Nearly every day'. Total scores range from 0-24, with 0-4: No significant depressive symptoms, 5-9: Mild depression, 10-14: Moderate depression, 15-19: Moderately severe depression, and 20-24: Severe depression.	Baseline, 12 weeks, 24 weeks

Collaborators and Investigators

• Sponsor: Mayo Clinic
• Investigators: Principal Investigator: Xiao Jing (Iris) Wang, M.D., Mayo Clinic

Study record dates

Study Major Dates

• Study Start (Actual): February 20, 2025
• Primary Completion (Estimated): January 1, 2027
• Study Completion (Estimated): February 1, 2027

Study Registration Dates

• First Submitted: February 12, 2025
• First Submitted That Met QC Criteria: February 20, 2025
• First Posted (Actual): February 26, 2025

Study Record Updates

• Last Update Posted (Actual): March 4, 2026
• Last Update Submitted That Met QC Criteria: March 2, 2026
• Last Verified: February 1, 2026

More Information

Terms related to this study

• Keywords: hypnotherapy; disorders of gut-brain interaction
• Additional Relevant MeSH Terms: Therapeutics; Mind-Body Therapies; Complementary Therapies; Psychotherapy; Behavioral Disciplines and Activities; Hypnosis
• Other Study ID Numbers: 24-007628

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: Yes