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Behavioral Intervention
Hypnotherapy for Gastrointestinal Irritation
Rochester, MN
N/A
Recruiting
Led By Xiao Jing (Iris) Wang, M.D.
Research Sponsored by Mayo Clinic
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
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
Be older than 18 years old
Must not have
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 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
Timeline
Screening 3 weeks
Treatment Varies
Follow Up baseline, 12 weeks, 24 weeks
Awards & highlights
No Placebo-Only Group
Summary
"This trial aims to see if using hypnotherapy through digital means can improve your gastrointestinal symptoms."
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Who is the study for?
This trial is for English-speaking individuals with upper GI symptoms or bloating, who have reliable internet access and a smartphone. They must have undergone specific gastric emptying tests and not be changing doses of cannabinoid substances during the study. Exclusions include untreated H. pylori infection, significant psychiatric illness, substance abuse disorders, certain cognitive impairments, and various gastrointestinal conditions.Check my eligibility
What is being tested?
The trial is testing whether hypnotherapy sessions delivered digitally can alleviate upper gastrointestinal symptoms. Participants will also receive an educational module as part of the intervention to help manage their condition.See study design
What are the potential side effects?
Since this trial involves non-invasive interventions like hypnotherapy and education modules, side effects are minimal but may include discomfort due to relaxation techniques or emotional distress related to therapy content.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
My stomach empties normally after a test meal, and I don't have an untreated H. pylori infection.
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Exclusion Criteria
You may be eligible for the trial if you check “No” for criteria below:Select...
I do not have severe psychiatric illnesses like schizophrenia, bipolar disorder, or major depression with suicidal thoughts.
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Select...
I do not have a history of significant brain injuries or cognitive issues.
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Select...
I do not have SIBO, gastroparesis, rumination syndrome, chronic intestinal pseudo-obstruction, advanced connective tissue diseases like scleroderma, or uncontrolled IBD.
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Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ baseline, 12 weeks, 24 weeks
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~baseline, 12 weeks, 24 weeks
Treatment Details
Study Objectives
Study objectives can provide a clearer picture of what you can expect from a treatment.Primary study objectives
Change in Irritable Bowel Symptom Severity Index (IBS-SSS) score
Change in Patient Assessment of Upper Gastrointestinal Disorders Symptom Severity Index (PAGI-SYM) score
Secondary study objectives
Change in Alimetry Gut-Brain Wellbeing Survey (AGBW)
Change in Brief Illness Perception Questionnaire (BIPQ-R)
Change in EQ-5D
+7 moreAwards & Highlights
No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.
Trial Design
2Treatment groups
Experimental Treatment
Group I: HypnotherapyExperimental Treatment1 Intervention
7 pre-recorded hypnotherapy sessions delivered over 12 weeks via patient's own electronic device. Sessions are approximately 40 minutes long.
Group II: Educational moduleExperimental Treatment1 Intervention
Patient's will be given a link to a educational module that reviews chronic GI conditions, pathophysiology, and alternative treatment options.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Hypnotherapy
2016
Completed Phase 3
~810
Find a Location
Closest Location:Mayo Clinic· Rochester, MN
Who is running the clinical trial?
Mayo ClinicLead Sponsor
3,413 Previous Clinical Trials
3,208,723 Total Patients Enrolled
Xiao Jing (Iris) Wang, M.D.Principal InvestigatorMayo Clinic