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AzTrials

Gastrointestinal DiseaseNCT06890663

Telehealth-Delivered Gut-Directed Hypnotherapy for Managing GI Health

A study testing Nonspecific Hypnotherapy for Relaxation, Gut-Directed Hypnotherapy (GDH) and 3-month Follow-Up in people with Gastrointestinal Disease and Gastrointestinal Disorders, run by University of Central Florida at 1 site in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

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. Read more about this study

Who is it for?
Ages 18 years and older
What is being tested?
Nonspecific Hypnotherapy for Relaxation, Gut-Directed Hypnotherapy (GDH) and 3-month Follow-Up
Could I receive a placebo?
No, everyone receives an active treatment
How many people
11 participants
Where
1 siteUnited States
Study dates
19 Mar 2025to 30 Oct 2025
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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

Who cannot join

  • 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)

Trial locations and contacts

1 site in 1 country.

United States1 site
  • University of Central Florida

    Orlando, Florida, 32816

Other trials in United States

About this study

Official title: The Use of Telehealth-Delivered Gut-Directed Hypnotherapy for Managing Gastrointestinal 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.

Read the detailed description

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.

Being tested
Nonspecific Hypnotherapy for Relaxation, Gut-Directed Hypnotherapy (GDH), 3-month Follow-Up
Keywords
Irritable Bowel Syndrome, Gastroesophageal Reflux Disease
Medical subject headings
Gastrointestinal Diseases, Neurologic Manifestations, Irritable Bowel Syndrome, Gastroesophageal Reflux

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Nonspecific Hypnotherapy for RelaxationOther

    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-UpOther

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

Study groups in NCT06890663
Study groupRoleWhat they receive
Group 1Active comparatorTotal 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.
Receives: Other: Nonspecific Hypnotherapy for Relaxation; Other: Gut-Directed Hypnotherapy (GDH); Other: 3-month Follow-Up
Group 2Active comparatorTotal 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.
Receives: Other: Nonspecific Hypnotherapy for Relaxation; Other: Gut-Directed Hypnotherapy (GDH); Other: 3-month Follow-Up

What is being measured

The primary outcome is the main question the study is designed to answer.

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

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

    Measured: 4 months

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

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

    Measured: 4 months

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

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

    Measured: 4 months

  4. Patient Reported Outcome (PRO)

    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

    Measured: 4 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted24 Mar 2025
  2. Study start19 Mar 2025
  3. Primary completion30 Oct 2025
  4. Study completion30 Oct 2025

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Supportive care
Allocation
Randomised
Intervention model
Crossover
Masking
None (open label)
Enrolment
11 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06890663
Sponsor's protocol ID
STUDY00007687
Status last verified
Nov 2025
First submitted
20 Mar 2025
Last updated
4 Nov 2025
Results posted
No
FDA-regulated drug
No
FDA-regulated device
No

Questions about this trial

What is this clinical trial studying?

A study testing Nonspecific Hypnotherapy for Relaxation, Gut-Directed Hypnotherapy (GDH) and 3-month Follow-Up in people with Gastrointestinal Disease and Gastrointestinal Disorders, run by University of Central Florida at 1 site in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 4 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 4 Nov 2025. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Patient- Reported Outcome Measurement Information System (PROMIS) (time frame: 4 months). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 4 Nov 2025.

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