Gut-Directed Hypnotherapy for Gastrointestinal Disorders

Overseen By Dr. Jeffrey Cassisi, PhD

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: University of Central Florida

Disqualifiers: Pregnant, Prisoners, Severe mental illness, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: 9

30 Participants Needed

Trial Summary

Will I have to stop taking my current medications?

The trial information does not specify whether you need to stop taking your current medications.

What data supports the effectiveness of the treatment Gut-Directed Hypnotherapy (GDH) for gastrointestinal disorders?

Research shows that Gut-Directed Hypnotherapy (GDH) is effective for treating irritable bowel syndrome (IBS), with studies highlighting its success in both individual and group settings, as well as through remote and digital formats. ^{1 2 3 4 5}

Is gut-directed hypnotherapy safe for humans?

The research on gut-directed hypnotherapy (GDH) primarily focuses on its effectiveness for irritable bowel syndrome (IBS), but it does not report any significant safety concerns, suggesting it is generally safe for humans. ^{1 2 3 5 6}

How is Gut-Directed Hypnotherapy different from other treatments for gastrointestinal disorders?

Gut-Directed Hypnotherapy (GDH) is unique because it uses hypnosis to help manage the connection between the brain and gut, which can be particularly effective for conditions like irritable bowel syndrome (IBS). Unlike traditional treatments that may focus on medication or diet changes, GDH can be delivered in various formats, including group sessions, remote therapy, and even through smartphone apps, making it more accessible and flexible for patients. ^{1 2 3 5 6}

What is the purpose of this trial?

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.

Research Team

Jeffrey Cassisi, PhD

Principal Investigator

University of Central Florida

Eligibility Criteria

This trial is for adults who speak English and have gastrointestinal symptoms that suggest a gut-brain interaction disorder. They must be willing to attend all hypnotherapy sessions and complete surveys. It's not for children, pregnant women, prisoners, or those with severe mental illness or low hypnotic susceptibility.

Inclusion Criteria

English speaking

I experience stomach or bowel problems that affect my mood or brain.

I am willing to attend all hypnotherapy sessions and fill out all surveys.

Exclusion Criteria

I am under 18 years old.

Pregnant women

Prisoners

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment Phase 1

Participants receive nonspecific hypnotherapy for relaxation via Zoom sessions

2 weeks

4 sessions (virtual)

Treatment Phase 2

Participants receive Gut-Directed Hypnotherapy (GDH) via Zoom sessions

2 weeks

4 sessions (virtual)

Follow-up

Participants are monitored for safety and effectiveness after treatment

3 months

1 follow-up assessment (virtual)

Treatment Details

Interventions

• Gut-Directed Hypnotherapy (GDH)

Trial Overview The study tests the effects of two types of hypnotherapy: one aimed at relaxation and another specifically targeting the gut (GDH). Both are delivered via telehealth. The effectiveness will be measured over three months to see how they manage gastrointestinal health.

Participant Groups

Group I: Group 1 Active Control 3 Interventions

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.

Group II: Group 2 Active Control 3 Interventions

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.

Who Is Running the Clinical Trial?

University of Central Florida

Lead Sponsor

Trials

101

Recruited

1,191,000+

Findings from Research

Gut-directed hypnotherapy has been shown to significantly reduce gastrointestinal symptoms in patients with irritable bowel syndrome (IBS), with response rates ranging from 24% to 73% and long-term efficacy maintained in several studies.

The technique may also help maintain clinical remission in patients with ulcerative colitis, but more research is needed to determine its role as a primary or adjunctive therapy and to address gaps in understanding its application.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Review article: gut-directed hypnotherapy in the management of irritable bowel syndrome and inflammatory bowel disease. Peters, SL., Muir, JG., Gibson, PR.[2022]

References

1. United States pubmed.ncbi.nlm.nih.gov

Long-term success of GUT-directed group hypnosis for patients with refractory irritable bowel syndrome: a randomized controlled trial. [2013]

2. England pubmed.ncbi.nlm.nih.gov

Patient satisfaction after remotely delivered gut-directed hypnotherapy for irritable bowel syndrome during the COVID-19 era: implications for future practice. [2022]

3. United States pubmed.ncbi.nlm.nih.gov

A Randomized Parallel-group Study of Digital Gut-directed Hypnotherapy vs Muscle Relaxation for Irritable Bowel Syndrome. [2023]

4. United States pubmed.ncbi.nlm.nih.gov

Hypnosis and Cognitive Behavioral Therapies for the Management of Gastrointestinal Disorders. [2021]

5. England pubmed.ncbi.nlm.nih.gov

Review article: gut-directed hypnotherapy in the management of irritable bowel syndrome and inflammatory bowel disease. [2022]

6. England pubmed.ncbi.nlm.nih.gov

Improving access to gut-directed hypnotherapy for irritable bowel syndrome in the digital therapeutics' era: Are mobile applications a "smart" solution? [2023]