Treatment of Upper Gastrointestinal Symptoms Using Hypnotherapy Sessions

Not Applicable

Recruiting

• Conditions: GI Symptoms

• Registration Number: NCT06846359
• Lead Sponsor: Mayo Clinic

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

Study Timeline

• Status Verified: 2025-01
• Study First Submitted: 2025-02-12
• Study Start: 2025-02-20
• Study First Submitted QC: 2025-02-20
• Study First Posted: 2025-02-26
• Last Update Submitted: 2025-03-10
• Last Update Posted: 2025-03-11
• Primary Completion: 2026-02-01
• Study Completion: 2027-02-01

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 100

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
Change in Irritable Bowel Symptom Severity Index (IBS-SSS) score	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	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).

Secondary Outcome Measures

Name	Time	Method
Change in Patient Assessment of Upper Gastrointestinal Disorders-Quality of Life (PAGI-QOL)	Baseline, 12 weeks, 24 weeks	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.
Change in Gastroparesis Cardinal Symptom Index (GCSI) score	Baseline, 12 weeks, 24 weeks	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.
Change in abdominal girth	Baseline, 12 weeks
Change in Personal Health Questionnaire Depression Scale (PHQ-8)	Baseline, 12 weeks, 24 weeks	The Personal Health Questionnaire Depression Scale (PHQ-8) is an 8-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.
Change in Work Productivity and Activity Impairment - General Health (WPAI-GH)	baseline, 12 weeks, 24 weeks	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.
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	Baseline, 12 weeks, 24 weeks	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.
Change in General Anxiety Disorder 7-item (GAD 7)	Baseline, 12 weeks, 24 weeks	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.
Change in Perceived Stress Scale (PSS-4)	Baseline, 12 weeks, 24 weeks	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).
Change in Alimetry Gut-Brain Wellbeing Survey (AGBW)	Baseline, 12 weeks, 24 weeks	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.
Change in Brief Illness Perception Questionnaire (BIPQ-R)	Baseline, 12 weeks, 24 weeks	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.
Change in Visceral Sensitivity Index (VSI)	Baseline, 12 weeks, 24 weeks	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.

Trial Locations

Locations (1)

Mayo Clinic; 🇺🇸 Rochester, Minnesota, United States