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Completed

NCT Number: NCT06890663

Telehealth-Delivered Gut-Directed Hypnotherapy for Managing GI Health

This study aims to evaluate the specific and non-specific effects of hypnotherapy and to evaluate the efficacy of group-format gut-directed hypnotherapy (GDH) delivered via telehealth for managing gastrointestinal health.

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Key information

About this study

Disorders of gut-brain interactions (DGBI) (also known as functional gastrointestinal disorders (FGID)) are defined as distinct combinations of chronic or recurrent gastrointestinal symptoms, with no obvious structural or biochemical abnormalities that explain symptomatology (Fairlieetal.,2023). DGBI symptoms are most likely generated based on a complex interaction among factors such as microbial dysbiosis within the gut, altered mucosal immune function, altered gut signaling (visceral hypersensitivity), and central nervous system dysregulation of the modulation of gut signaling and motor function (Drossman et al., 2016). Additionally, researchers have identified a bi-directional communication pathway between the central nervous system and the gastrointestinal (GI) tract, termed the gut-brain axis. The gut-brain axis suggests that changes in either the central nervous system or gut can disrupt the balance of the other. Therefore, psychosocial factors impacting the gut-brain axis increase GI symptoms and symptom severity and affect treatment outcomes (Vivier et al., 2020), and GI symptoms reduce psychosocial functioning in a reciprocal fashion.

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 18 years or older
  • 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

  • Under 18 years
  • 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)

Treatment and study plan

Nonspecific Hypnotherapy for Relaxation

Other

A therapeutic technique that uses hypnosis for relaxation.

Gut-Directed Hypnotherapy (GDH)

Other

A therapeutic technique that uses hypnosis and relaxation to help with gastrointestinal (GI) disorders.

3-month Follow-Up

Other

A 3-month follow is completed after both intervention phases (general hypnotherapy and Gut Directed Hypnotherapy) are completed for each participant.

Primary outcomes

  1. Patient- Reported Outcome Measurement Information System (PROMIS)

    Time frame: 4 months

    An NIH (National Institutes of Health)-funded initiative to develop and validate patient reported outcomes for clinical research and practice.

  2. General Anxiety Disorder-7 (GAD-7)

    Time frame: 4 months

    A screening tool used to assess the severity of generalized anxiety disorder

  3. Patient Health Questionnaire-9 (PHQ-9)

    Time frame: 4 months

    A self-administered questionnaire used to screen for and assess the severity of depressive symptoms

  4. Patient Reported Outcome (PRO)

    Time frame: 4 months

    An assessment that directly captures a patient's self-reported health status, including their symptoms, quality of life, and functional ability, without interpretation from a healthcare provider

Sponsors and collaborators

Lead sponsor

University of Central Florida

Other

Registry information

Official study title

The Use of Telehealth-Delivered Gut-Directed Hypnotherapy for Managing Gastrointestinal Health

Important dates

Study start
2025
Primary completion
2025
Study completion
2025
First posted
Mar 24, 2025
Registry last updated
Nov 4, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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