Treatment of Upper Gastrointestinal Symptoms Using Hypnotherapy Sessions

NCT06846359 | Recruiting

• 1 other identifier: 24-007628
• Study Type: interventional
• Target: 100
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

GI Symptoms

Keywords

hypnotherapy; disorders of gut-brain interaction

Outcome Measures

Primary Outcomes (2)

• 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 Outcomes (13)

• Change in Gastroparesis Cardinal Symptom Index (GCSI) score

  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)

  Baseline, 12 weeks, 24 weeks

• Change in Personal Health Questionnaire Depression Scale (PHQ-9)

  Baseline, 12 weeks, 24 weeks

• Change in Work Productivity and Activity Impairment - General Health (WPAI-GH)

  baseline, 12 weeks, 24 weeks

Study Arms (2)

Hypnotherapy

EXPERIMENTAL

7 pre-recorded hypnotherapy sessions delivered over 12 weeks via patient's own electronic device. Sessions are approximately 40 minutes long.

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.

Behavioral: Educational module

Interventions

Hypnotherapy BEHAVIORAL

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.

Hypnotherapy

Educational module BEHAVIORAL

self-guided online module reviewing chronic GI conditions, pathophysiology, and alternative treatment options.

Educational module

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.
• 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.
• Stable doses medications are permissible, but dosing should not be changed during study period.
• Patients who are pregnant.

Sponsors & Collaborators

• Mayo Clinic: lead

Study Sites (1)

Mayo Clinic

Rochester, Minnesota, 55905, United States

RECRUITING

MeSH Terms

Interventions

Hypnosis

Intervention Hierarchy (Ancestors)

Mind-Body Therapies; Complementary Therapies; Therapeutics; Psychotherapy; Behavioral Disciplines and Activities

Study Officials

• Xiao Jing (Iris) Wang, M.D.

  Mayo Clinic

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Taylor Hines

CONTACT

507-538-9959; Hines.taylor@mayo.edu

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: February 12, 2025
• First Posted: February 26, 2025
• Study Start: February 20, 2025
• Primary Completion (Estimated): January 1, 2027
• Study Completion (Estimated): February 1, 2027
• Last Updated: March 4, 2026

Record last verified: 2026-02

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)