Clinical trial NCT06846359: Treatment of Upper Gastrointestinal Symptoms Using Hypnotherapy Sessions
Official title: The Impact Of Gastric Phenotyping In Predicting And Assessing The Clinical Success Of Gut-Directed Hypnotherapy For Patients With Gastroduodenal DGBIS.
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: GI Symptoms
Keywords: hypnotherapy
disorders of gut-brain interaction
Lead sponsor: Mayo Clinic
Sponsor class: OTHER
First posted: 2025-02-26
Enrollment: 100
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: 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 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

Eligibility criteria: 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.

Primary outcomes:
measure: Change in Irritable Bowel Symptom Severity Index (IBS-SSS) score
timeFrame: Baseline, 12 weeks, 24 weeks
measure: Change in Patient Assessment of Upper Gastrointestinal Disorders Symptom Severity Index (PAGI-SYM) score
timeFrame: Baseline, 12 weeks, 24 weeks
Secondary outcomes:
measure: Change in Gastroparesis Cardinal Symptom Index (GCSI) score
timeFrame: Baseline, 12 weeks, 24 weeks
measure: Change in abdominal girth
timeFrame: Baseline, 12 weeks
measure: Change in Patient Assessment of Upper Gastrointestinal Disorders-Quality of Life (PAGI-QOL)
timeFrame: Baseline, 12 weeks, 24 weeks
measure: Change in Personal Health Questionnaire Depression Scale (PHQ-8)
timeFrame: Baseline, 12 weeks, 24 weeks
measure: Change in Work Productivity and Activity Impairment - General Health (WPAI-GH)
timeFrame: baseline, 12 weeks, 24 weeks
measure: 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.
timeFrame: End of study analysis, roughly 1 year
measure: Satisfaction with digital delivery platform will be assessed utilizing survey at the end of treatment.
timeFrame: 12 weeks
measure: Change in EQ-5D
timeFrame: Baseline, 12 weeks, 24 weeks
measure: Change in General Anxiety Disorder 7-item (GAD 7)
timeFrame: Baseline, 12 weeks, 24 weeks
measure: Change in Perceived Stress Scale (PSS-4)
timeFrame: Baseline, 12 weeks, 24 weeks
measure: Change in Alimetry Gut-Brain Wellbeing Survey (AGBW)
timeFrame: Baseline, 12 weeks, 24 weeks
measure: Change in Brief Illness Perception Questionnaire (BIPQ-R)
timeFrame: Baseline, 12 weeks, 24 weeks
measure: Change in Visceral Sensitivity Index (VSI)
timeFrame: Baseline, 12 weeks, 24 weeks
Other outcomes:
Locations:
city: Rochester
country: United States
facility: Mayo Clinic
state: Minnesota
Study officials:
affiliation: Mayo Clinic
name: Xiao Jing (Iris) Wang, M.D.
role: PRINCIPAL_INVESTIGATOR
References: