GI SymptomsNCT06846359
Treatment of Upper Gastrointestinal Symptoms Using Hypnotherapy Sessions
A study testing Hypnotherapy and Educational module in people with GI Symptoms, run by Mayo Clinic at 1 site in United States.
Trial summary
The purpose of this research is to evaluate if hypnotherapy delivered digitally will help your GI symptoms. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- GI Symptoms
- What is being tested?
- Hypnotherapy and Educational module
- Type of treatment
- Pill or oral medicine, Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 100 participants
- Where
- 1 siteUnited States
- Study dates
- 20 Feb 2025to 1 Feb 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
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- 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 locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
Mayo Clinic
Rochester, Minnesota, 55905
Shelly Ward, 507-538-9997, Ward.shelly1@mayo.edu
Xiao Jing Wang, MD
About this study
Official title: 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.
Read the 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
- Being tested
- Hypnotherapy, Educational module
- Keywords
- hypnotherapy, disorders of gut-brain interaction
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
HypnotherapyBehavioural
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 moduleBehavioural
self-guided online module reviewing chronic GI conditions, pathophysiology, and alternative treatment options.
| Study group | Role | What they receive |
|---|---|---|
| Hypnotherapy | Experimental | 7 pre-recorded hypnotherapy sessions delivered over 12 weeks via patient's own electronic device. Sessions are approximately 40 minutes long. Receives: Behavioral: Hypnotherapy |
| Educational module | Other | Patient's will be given a link to a educational module that reviews chronic GI conditions, pathophysiology, and alternative treatment options. Receives: Behavioral: Educational module |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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).
Measured: Baseline, 12 weeks, 24 weeks
Secondary outcomes (13)
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.
Measured: Baseline, 12 weeks, 24 weeks
Change in abdominal girth
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: End of study analysis, roughly 1 year
Satisfaction with digital delivery platform will be assessed utilizing survey at the end of treatment.
Measured: 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.
Measured: 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.
Measured: 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).
Measured: 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.
Measured: 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.
Measured: 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.
Measured: Baseline, 12 weeks, 24 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Feb 2025
- Study start20 Feb 2025
- Primary completion1 Jan 2027 (estimated)
- Study completion1 Feb 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for GI SymptomsStudies of the same condition, open and under way.
- More trials run by Mayo ClinicThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Mayo Clinic
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Xiao Jing (Iris) Wang, Mayo Clinic
- Investigators
- Xiao Jing (Iris) Wang, M.D., Principal investigator, Mayo Clinic
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06846359
- Sponsor's protocol ID
- 24-007628
- Status last verified
- Feb 2026
- First submitted
- 12 Feb 2025
- Last updated
- 4 Mar 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 4 Mar 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Impact Of Gastric Phenotyping In Predicting And Assessing The Clinical Success Of Gut-Directed Hypnotherapy For Patients With Gastroduodenal DGBIS.
- ClinicalTrials.gov ID
- NCT06846359
- Acronym / sponsor ID
- 24-007628
- Conditions
- GI Symptoms
- Keywords
- hypnotherapy, disorders of gut-brain interaction
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- Mayo ClinicUniversity, hospital or other
- Study start
- 20 Feb 2025 (actual)
- Primary completion
- 1 Jan 2027 (estimated)
- Study completion
- 1 Feb 2027 (estimated)
- First posted
- 26 Feb 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Hypnotherapy | Experimental | Behavioral: Hypnotherapy7 pre-recorded hypnotherapy sessions delivered over 12 weeks via patient's own electronic device. Sessions are approximately 40 minutes long. |
| Educational module | Other | Behavioral: Educational modulePatient's will be given a link to a educational module that reviews chronic GI conditions, pathophysiology, and alternative treatment options. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- 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
Key exclusion criteria (10 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| HypnotherapySeven 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. | Behavioural | Hypnotherapy |
| Educational moduleself-guided online module reviewing chronic GI conditions, pathophysiology, and alternative treatment options. | Behavioural | Educational module |
Primary outcome
Change in Irritable Bowel Symptom Severity Index (IBS-SSS) score
Time frame: Baseline, 12 weeks, 24 weeks
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.
Change in Patient Assessment of Upper Gastrointestinal Disorders Symptom Severity Index (PAGI-SYM) score
Time frame: Baseline, 12 weeks, 24 weeks
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).
13 secondary outcomes
Change in Gastroparesis Cardinal Symptom Index (GCSI) score
Time frame: Baseline, 12 weeks, 24 weeks
Change in abdominal girth
Time frame: Baseline, 12 weeks
Change in Patient Assessment of Upper Gastrointestinal Disorders-Quality of Life (PAGI-QOL)
Time frame: Baseline, 12 weeks, 24 weeks
Change in Personal Health Questionnaire Depression Scale (PHQ-9)
Time frame: Baseline, 12 weeks, 24 weeks
Change in Work Productivity and Activity Impairment - General Health (WPAI-GH)
Time frame: 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.
Time frame: End of study analysis, roughly 1 year
Satisfaction with digital delivery platform will be assessed utilizing survey at the end of treatment.
Time frame: 12 weeks
Change in EQ-5D
Time frame: Baseline, 12 weeks, 24 weeks
Change in General Anxiety Disorder 7-item (GAD 7)
Time frame: Baseline, 12 weeks, 24 weeks
Change in Perceived Stress Scale (PSS-4)
Time frame: Baseline, 12 weeks, 24 weeks
Change in Alimetry Gut-Brain Wellbeing Survey (AGBW)
Time frame: Baseline, 12 weeks, 24 weeks
Change in Brief Illness Perception Questionnaire (BIPQ-R)
Time frame: Baseline, 12 weeks, 24 weeks
Change in Visceral Sensitivity Index (VSI)
Time frame: Baseline, 12 weeks, 24 weeks
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Mar 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Xiao Jing (Iris) Wang, M.D. principal investigator
Mayo Clinic
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Hypnotherapy and Educational module in people with GI Symptoms, run by Mayo Clinic at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 4 Mar 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Taylor Hines (507-538-9959, Hines.taylor@mayo.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in Irritable Bowel Symptom Severity Index (IBS-SSS) score (time frame: Baseline, 12 weeks, 24 weeks). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 4 Mar 2026.