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

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial explores the effectiveness of hypnotherapy for individuals with ongoing gut issues. It examines two types of hypnotherapy: one focused on relaxation and the other specifically targeting gut health (Gut-Directed Hypnotherapy). Individuals who suspect their gut problems are linked to stress or emotional issues might find this trial beneficial. Sessions are held online, allowing participants to join from home. Those who regularly experience gut discomfort and believe it's tied to stress should consider participating. As an unphased trial, this study offers a unique opportunity to explore innovative hypnotherapy techniques from home.

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 prior data suggests that gut-directed hypnotherapy is safe for managing gastrointestinal health?

Studies have shown that gut-directed hypnotherapy (GDH) is very safe for treating stomach and digestive issues. Research indicates that GDH is not only safe but also effective, even for people whose symptoms haven't improved with other treatments. Various trials have demonstrated GDH's safety, with no reports of serious side effects.

Additionally, GDH is provided through telehealth, allowing sessions to be conducted online, which is both convenient and safe. Participants have experienced improvements in symptoms, such as reduced stomach pain and better overall well-being.

For those considering joining a clinical trial for GDH, evidence suggests it is a well-tolerated approach. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Gut-Directed Hypnotherapy (GDH) is unique because it offers a non-drug approach to managing gastrointestinal disorders, unlike standard treatments like antispasmodics, dietary changes, or medications like probiotics. Researchers are excited about GDH because it uses the mind-body connection to specifically target and alleviate gut symptoms through hypnosis, which can be more personalized and potentially reduce the side effects associated with medications. Additionally, the delivery method via Zoom sessions makes it accessible and convenient, allowing people to receive treatment from the comfort of their homes. This approach not only broadens treatment options but could also lead to a better understanding of the psychological influences on gut health.

What evidence suggests that Gut-Directed Hypnotherapy is effective for gastrointestinal disorders?

Research has shown that gut-directed hypnotherapy (GDH) can effectively treat stomach and digestive problems. In one study with 378 participants, 70% reported significant improvement in their irritable bowel syndrome (IBS) symptoms. Another study found that a digital GDH program reduced stomach pain and improved bowel movements in IBS patients. An app-based GDH proved more effective than educational programs in easing IBS symptoms. This trial will compare GDH with nonspecific hypnotherapy for relaxation, presented in a counterbalanced order. This evidence suggests that GDH is a promising treatment for managing gut health issues. ^{1 2 4 6 7}

Who Is on the Research Team?

Jeffrey Cassisi, PhD

Principal Investigator

University of Central Florida

Are You a Good Fit for This Trial?

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 for a Trial Participant

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)

What Are the Treatments Tested in This Trial?

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.

How Is the Trial Designed?

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+

Published Research Related to This Trial

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]

Citations

1. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC6850508/

Gut‐focused hypnotherapy for Functional Gastrointestinal ... Gut‐focused hypnotherapy, when delivered by trained therapists, has been shown to be highly effective in severe refractory FGIDs.

2. cghjournal.org cghjournal.org/article/S1542-3565(23)00500-1/fulltext

A Randomized Parallel-group Study of Digital Gut-directed ... Treatment with a digital GDH program led to an improvement in abdominal pain and stool symptoms in patients with IBS, supporting a role for this intervention.

3. clinicaltrials.gov clinicaltrials.gov/study/NCT06890663

Telehealth-Delivered Gut-Directed Hypnotherapy for ... 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) ...

4. frontiersin.org frontiersin.org/journals/psychology/articles/10.3389/fpsyg.2024.1389911/full

Gut-directed hypnosis and hypnotherapy for irritable bowel ... In a randomized controlled trial including 378 participants, 70% of the participants reported a clinically relevant reduction of IBS symptoms ...

5. ddw.digitellinc.com ddw.digitellinc.com/p/s/app-delivered-gut-directed-hypnotherapy-is-superior-to-psychoeducation-in-reducing-symptoms-associated-with-irritable-bowel-syndrome-a-randomised-control-trial-7150

APP-DELIVERED GUT-DIRECTED HYPNOTHERAPY IS ... App-delivered GDH program, Nerva, is superior to psychoeducation in terms of improving IBS symptoms to a lower level and in a greater percent of participants.

6. onlinelibrary.wiley.com onlinelibrary.wiley.com/doi/10.1111/nmo.70037

Gut‐Directed Hypnotherapy for Irritable Bowel Syndrome ... Our systematic review and meta-analysis showed that gut-directed hypnotherapy (GDH) may improve global symptoms of IBS.

7. sciencedirect.com sciencedirect.com/science/article/pii/S1542356523007498

Development and Current State of Digital Therapeutics for ... Among 190 users providing outcome data, abdominal pain was reduced by more than 50% from baseline to study completion (P < .001), and 64% of patients were ...