Clinical trial NCT05572606: Treatment of Symptomatic Bloating Using a Novel Hypnotherapy Protocol
Official title: Development and Delivery of a Novel Hypnotherapy Protocol for Treatment of Symptomatic Bloating
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: NA
Conditions: Bloating
Keywords: Hypnotherapy
Lead sponsor: Mayo Clinic
Sponsor class: OTHER
First posted: 2022-10-07
Enrollment: 25
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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

Detailed 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.

Eligibility criteria: 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.

Primary outcomes:
measure: Change in abdominal bloating severity
timeFrame: Baseline, 6 weeks, 12 weeks, and 3 months
Secondary outcomes:
measure: Bloating symptoms
timeFrame: Baseline, 6 weeks, 12 weeks, and 3 months
measure: Change in perception of GI symptoms
timeFrame: Baseline, 6 weeks, 12 weeks, and 3 months
measure: Change in quality of life
timeFrame: Baseline, 6 weeks, 12 weeks, and 3 months
measure: Health care utilization
timeFrame: Baseline, 12 weeks, and 3 months
Other outcomes:
Locations:
city: Rochester
country: United States
facility: Mayo Clinic Rochester
state: Minnesota
Study officials:
affiliation: Mayo Clinic
name: Xiao Jing (Iris) Wang, MD
role: PRINCIPAL_INVESTIGATOR
References: