Telehealth-Delivered Gut-Directed Hypnotherapy for Managing GI Health

NCT06890663 | Completed

• 1 other identifier: STUDY00007687
• Study Type: interventional
• Target: 11
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Gastrointestinal Disease; Gastrointestinal Disorders; Nervous System

Keywords

Irritable Bowel Syndrome; Gastroesophageal Reflux Disease

Outcome Measures

Primary Outcomes (4)

• 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.

  4 months

• General Anxiety Disorder-7 (GAD-7)

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

  4 months

• Patient Health Questionnaire-9 (PHQ-9)

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

  4 months

• 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

  4 months

Study Arms (2)

Group 1

ACTIVE COMPARATOR

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.

Other: Nonspecific Hypnotherapy for Relaxation; Other: Gut-Directed Hypnotherapy (GDH); Other: 3-month Follow-Up

Group 2

ACTIVE COMPARATOR

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.

Other: Nonspecific Hypnotherapy for Relaxation; Other: Gut-Directed Hypnotherapy (GDH); Other: 3-month Follow-Up

Interventions

Nonspecific Hypnotherapy for Relaxation OTHER

A therapeutic technique that uses hypnosis for relaxation.

Group 1; Group 2

Gut-Directed Hypnotherapy (GDH) OTHER

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

Group 1; Group 2

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.

Group 1; Group 2

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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)

Sponsors & Collaborators

• University of Central Florida: lead

Study Sites (1)

University of Central Florida

Orlando, Florida, 32816, United States

Location

MeSH Terms

Conditions

Gastrointestinal Diseases; Neurologic Manifestations; Irritable Bowel Syndrome; Gastroesophageal Reflux

Condition Hierarchy (Ancestors)

Digestive System Diseases; Nervous System Diseases; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Colonic Diseases, Functional; Colonic Diseases; Intestinal Diseases; Esophageal Motility Disorders; Deglutition Disorders; Esophageal Diseases

Study Officials

• Jeffrey Cassisi, PhD

  University of Central Florida

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 20, 2025
• First Posted: March 24, 2025
• Study Start: March 19, 2025
• Primary Completion: October 30, 2025
• Study Completion: October 30, 2025
• Last Updated: November 4, 2025

Record last verified: 2025-11

Locations

US (1)