Telehealth-Delivered Gut-Directed Hypnotherapy for Managing GI Health
NCT ID: NCT06890663
Last Updated: 2025-11-04
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
NA
11 participants
INTERVENTIONAL
2025-03-19
2025-10-30
Brief Summary
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Detailed Description
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The bi-directional communication system between the gut and brain is thought to play a critical role in maintaining gastrointestinal health and homeostasis, and an imbalance in either can have adverse consequences, often seen in conditions like IBS (Vivier et al., 2020). This is termed the gut-brain axis. It involves a complex interaction between the central nervous system (CNS) and the enteric nervous system (ENS), both of which regulate gut function and are affected by psychological states. Reflexes that generate appropriate gut responses to physiological as well as pathological afferent gut signals occur at the level of the ENS (Peters et al., 2015). Given this intricate connection, therapeutic approaches that target both physiological and psychological aspects may be particularly beneficial.
Based on the Rome IV criteria, there are several categories of DGBI including 1.) esophageal (e.g. gastroesophageal reflux disease (GERD, esophageal spasms)), 2.) gastroduodenal (e.g. chronic gastritis, peptic ulcer disease), 3.) bowel (e.g. irritable bowel syndrome (IBS), 4.) functional diarrhea), 5.) centrally mediated disorders of gastrointestinal (GI) pain (e.g. functional heartburn, functional abdominal pain syndrome (FAPS)), 6.) gallbladder and sphincter of oddie (e.g. sphincter of oddi dysfunction (SOD), biliary dyskinesia), 7.) anorectal (e.g. functional constipation, functional fecal incontinence), and 8.) childhood functional GI disorders (e.g. diarrhea, constipation, abdominal pain). A recent global internet survey of 54,127 adults across 26 countries found that 43% of people met the criteria for at least one FGID (Black et al., 2020). To date, there have not emerged highly effective interventions for these disorders, making it essential to explore innovative treatments. One such promising approach has been gut-directed hypnotherapy (GDH). The current study aims to evaluate (a) whether GDH offers symptom relief beyond the shared components of hypnotherapy and (b) the efficacy of GDH when delivered in group-based and telehealth formats. Findings will contribute to understanding GDH's role in DGBI management, in addition to its effectiveness in a group-based, telehealth format.
Conditions
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Study Design
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RANDOMIZED
CROSSOVER
SUPPORTIVE_CARE
NONE
Study Groups
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Group 1
Total enrollment time in the study will be 4 months. Participants will be divided into two groups of ten, and treatment will be provided in two 14-day intervention phases with one 3-month follow-up . One phase will include nonspecific hypnotherapy for relaxation, and one phase will include Gut-Directed Hypnotherapy (GDH) presented in a counterbalanced order depending on random assignment. Treatment conditions will be presented in a counterbalanced order depending on random assignment
Hypnotherapy sessions will take place via Zoom sessions. There will be 4 sessions within each fourteen-day phase. Outcomes will be assessed through pre- and post-phase surveys, along with pre-and post-session surveys and one 3-month follow-up after completion of the two intervention phases.
Nonspecific Hypnotherapy for Relaxation
A therapeutic technique that uses hypnosis for relaxation.
Gut-Directed Hypnotherapy (GDH)
A therapeutic technique that uses hypnosis and relaxation to help with gastrointestinal (GI) disorders.
3-month Follow-Up
A 3-month follow is completed after both intervention phases (general hypnotherapy and Gut Directed Hypnotherapy) are completed for each participant.
Group 2
Total enrollment time in the study will be 4 months. Participants will be divided into two groups of ten, and treatment will be provided in two 14-day intervention phases with one 3-month follow-up . One phase will include nonspecific hypnotherapy for relaxation, and one phase will include Gut-Directed Hypnotherapy (GDH) presented in a counterbalanced order depending on random assignment. Treatment conditions will be presented in a counterbalanced order depending on random assignment
Hypnotherapy sessions will take place via Zoom sessions. There will be 4 sessions within each fourteen-day phase. Outcomes will be assessed through pre- and post-phase surveys, along with pre-and post-session surveys and one 3-month follow-up after completion of the two intervention phases.
Nonspecific Hypnotherapy for Relaxation
A therapeutic technique that uses hypnosis for relaxation.
Gut-Directed Hypnotherapy (GDH)
A therapeutic technique that uses hypnosis and relaxation to help with gastrointestinal (GI) disorders.
3-month Follow-Up
A 3-month follow is completed after both intervention phases (general hypnotherapy and Gut Directed Hypnotherapy) are completed for each participant.
Interventions
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Nonspecific Hypnotherapy for Relaxation
A therapeutic technique that uses hypnosis for relaxation.
Gut-Directed Hypnotherapy (GDH)
A therapeutic technique that uses hypnosis and relaxation to help with gastrointestinal (GI) disorders.
3-month Follow-Up
A 3-month follow is completed after both intervention phases (general hypnotherapy and Gut Directed Hypnotherapy) are completed for each participant.
Eligibility Criteria
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Inclusion Criteria
* Self reported gastrointestinal symptoms consistent with disorders of gut-brain interaction
* English speaking
* Willingness to participate in all hypnotherapy sessions \& complete all pre- and post-session surveys
Exclusion Criteria
* Pregnant women
* Prisoners
* Children
* Individuals with active or a history of severe mental illness (e.g. active psychosis, dissociative disorders)
* A hypnotic susceptibility score in the low range (SHSS; total = 0-3)
18 Years
ALL
No
Sponsors
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University of Central Florida
OTHER
Responsible Party
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Principal Investigators
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Jeffrey Cassisi, PhD
Role: PRINCIPAL_INVESTIGATOR
University of Central Florida
Locations
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University of Central Florida
Orlando, Florida, United States
Countries
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Other Identifiers
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STUDY00007687
Identifier Type: -
Identifier Source: org_study_id
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