Treatment of Symptomatic Bloating Using a Novel Hypnotherapy Protocol

Bloating Clinical Trial

Official title:

Development and Delivery of a Novel Hypnotherapy Protocol for Treatment of Symptomatic Bloating

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT05572606
• Other study ID #: 22-005844
• Status: Active, not recruiting
• Phase: N/A
• Start date: November 30, 2022
• Est. completion date: September 2024

Study information

• Verified date: April 2024
• Source: Mayo Clinic
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

The purpose of this research is to evaluate if hypnotherapy delivered electronically will help with bloating symptoms.

Description:

This study 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. The whole study will last for 24 weeks: the initial 12-week treatment period and then an additional 12-week follow-up period.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 25
• Est. completion date: September 2024
• Est. primary completion date: September 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion criteria:

• Patients who meet Rome IV criteria for functional abdominal bloating/distension.

• Patients who meet criteria for other Rome IV Disorder of Gut Brain Interaction diagnoses (including but not limited to irritable bowel syndrome, functional constipation, or functional dyspepsia) may be included if bloating is their predominant symptom.

• 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 prior 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 known disaccharide intolerances may be included if dietary restrictions are maintained during the duration of the study.

• 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.

Related Conditions & MeSH terms

• Bloating

Intervention

Behavioral:
• Hypnotherapy
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.

Locations

Country	Name	City	State
United States	Mayo Clinic Rochester	Rochester	Minnesota

Sponsors (1)

Lead Sponsor	Collaborator
Mayo Clinic

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change in abdominal bloating severity	Measured on a 0-100 scale using the bloating severity question of the the validated Irritable Bowel Syndrome Symptom Severity Scale (IBS-SSS)	Baseline, 6 weeks, 12 weeks, and 3 months
Secondary	Bloating symptoms	Assessed using the well validated upper GI symptom Severity Index (PAGI-SYM)	Baseline, 6 weeks, 12 weeks, and 3 months
Secondary	Change in perception of GI symptoms	Measured using the self-reported Visceral Sensitivity Index (VSI)	Baseline, 6 weeks, 12 weeks, and 3 months
Secondary	Change in quality of life	Assessed via the self-reported EuroQol-5D-5L (EQ-5D-5L) to evaluate mobility, self-care, usual activity, pain/discomfort, and anxiety/depression	Baseline, 6 weeks, 12 weeks, and 3 months
Secondary	Health care utilization	Assessing the number of outpatient visits, portal messages, and procedures generated in three months	Baseline, 12 weeks, and 3 months