RCT of Gut-directed Hypnotherapy in Ehlers-Danlos Syndromes and Generalized Hypermobility Spectrum Disorders

NCT06325345 | Not Yet Recruiting

• 1 other identifier: 22-5277
• Study Type: interventional
• Target: 74
• Locations: 1 country
• Sites: 1

Brief Summary

This randomized, controlled trial (RCT) will evaluate the effectiveness of gut-directed hypnotherapy for management of Irritable Bowel Syndrome (IBS) in individuals diagnosed with Ehlers-Danlos Syndromes or Generalized Hypermobility Spectrum Disorders (G-HSD). Consenting patients recruited from the Toronto General Hospital GoodHope Ehlers-Danlos Syndrome Clinic will be randomly assigned to one of two groups: (1) standard medical therapy or (2) standard medical therapy plus eight sessions of gut-directed hypnotherapy. The main questions this study will answer are:

1. 1.Is gut-directed hypnotherapy an efficacious treatment for IBS symptoms among individuals with EDS or G-HSD?
2. 2.Does gut-directed hypnotherapy improve other gut symptoms, quality of life, visceral sensitivity, and emotional distress?
3. 3.Is the activity of the parasympathetic nervous system (i.e. the body's "rest and digest" system) associated with IBS symptoms or treatment outcomes among individuals with EDS or G-HSD?

Conditions

Ehlers-Danlos Syndrome; Irritable Bowel Syndrome; Hypermobility Syndrome; Gastrointestinal Dysfunction

Outcome Measures

Primary Outcomes (1)

• IBS Symptom Severity

  The IBS Symptoms Severity Score (IBS-SSS) is a 5-item measure that asks participants to rate abdominal pain intensity, abdominal distension, dissatisfaction with bowel habits, and IBS life interference on a 0-100 scale. The IBS-SSS is a validated measure of IBS symptom severity and a recommended outcome measure for IBS treatment trials

  Immediately post-treatment, 3-months post-treatment

Secondary Outcomes (4)

• Upper Gastrointestinal Symptoms

  Immediately post-treatment, 3-months post-treatment

• IBS-related Quality of Life

  Immediately post-treatment, 3-months post-treatment

• Visceral Sensitivity

  Immediately post-treatment, 3-months post-treatment

• Emotional Distress

  Immediately post-treatment, 3-months post-treatment

Other Outcomes (1)

• Weekly Ratings of GI Health and Medication Use

  Once a week for 9 weeks hypnotherapy treatment

Study Arms (2)

Standard Medical Therapy

OTHER

Standard Medical Treatment will be administered by board certified gastroenterologists through the EDS Clinic gastroenterology clinical care pathway. Therapies will be individualized to the participants' current symptoms and severity of symptoms as per current clinical guidelines for management of IBS. Potential therapies that may be administered include dietary changes, supplemental fibre, and pharmacotherapy (including neuromodulators) as appropriate.

Other: Standard Medical Therapy

Standard Medical Therapy plus Gut-Directed Hypnotherapy

EXPERIMENTAL

In addition to Standard Medical Therapy, participants randomized to this arm will attend 8 sessions of gut-directed hypnotherapy by a trained behavioral therapist. The treatment protocol developed for the proposed study was adapted from the empirically-supported Manchester Protocol for gut-directed hypnotherapy. At each visit, a voluntary, pleasant, and dream-like state of deep relaxation will be induced and suggestions made for greater relaxation, abdominal comfort, and normalization of gut function. The first session will be 90 minutes in duration and the remaining sessions will be 60 minutes. At the first session, participants will be provided with 30 minutes of education on the nature of the gut-brain axis and hypnotherapy before they undergo hypnotherapy.

Behavioral: Gut-directed hypnotherapy; Other: Standard Medical Therapy

Interventions

Gut-directed hypnotherapy BEHAVIORAL

Eight session gut-directed hypnotherapy for IBS symptoms adapted from the evidence-based Manchester protocol for treatment of IBS.

Standard Medical Therapy plus Gut-Directed Hypnotherapy

Standard Medical Therapy OTHER

Standard medical treatment will be administered by board certified gastroenterologists

Standard Medical Therapy; Standard Medical Therapy plus Gut-Directed Hypnotherapy

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Physician diagnosis of Ehlers-Danlos Syndrome or Generalized Hypermobility Spectrum Disorder
• Physician diagnosis of Irritable Bowel Syndrome according to the Rome IV criteria.
• If receiving pharmacologic therapy for IBS, they must be on a stable dose for 4 weeks prior to study enrollment

You may not qualify if:

• Patients with diagnosed lower bowel disease (e.g. inflammatory bowel disease, celiac's disease)
• Patients with history of major gastrointestinal surgery (except appendectomy and/or cholecystectomy \> 6 months prior to enrollment)
• Patients with limited comprehension of English or hearing difficulty who would not be able to understand the verbal instructions for clinical hypnosis
• Patients with a known history of serious mental illness (e.g., schizophrenia, dissociative identity disorder)
• Patients with cognitive deficits whose comprehension may limit benefit
• Patients with heavy alcohol use (\> 15 drinks/week for men, \> 10 drinks/week for women)

Sponsors & Collaborators

• University Health Network, Toronto: lead

Study Sites (1)

Toronto General Hospital

Toronto, Ontario, M5G 2C4, Canada

Location

MeSH Terms

Conditions

Ehlers-Danlos Syndrome; Irritable Bowel Syndrome

Condition Hierarchy (Ancestors)

Hemostatic Disorders; Vascular Diseases; Cardiovascular Diseases; Hemorrhagic Disorders; Hematologic Diseases; Hemic and Lymphatic Diseases; Skin Abnormalities; Congenital Abnormalities; Congenital, Hereditary, and Neonatal Diseases and Abnormalities; Skin Diseases, Genetic; Genetic Diseases, Inborn; Collagen Diseases; Connective Tissue Diseases; Skin and Connective Tissue Diseases; Skin Diseases; Colonic Diseases, Functional; Colonic Diseases; Intestinal Diseases; Gastrointestinal Diseases; Digestive System Diseases

Study Officials

• Louis Liu

  University Health Network, Toronto

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Misbah Salim Salim

CONTACT

4166035800; misbah.salim@uhn.ca

Study Design

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

Study Record Dates

• First Submitted: February 8, 2023
• First Posted: March 22, 2024
• Study Start: April 1, 2024
• Primary Completion: December 29, 2024
• Study Completion: April 1, 2025
• Last Updated: March 22, 2024

Record last verified: 2024-02

Data Sharing

• IPD Sharing: Will not share

Locations

CA (1)