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

Phase

N/A

Condition

Colic

Connective Tissue Diseases

Gastrointestinal Diseases And Disorders

Treatment

Standard Medical Therapy

Gut-directed hypnotherapy

Clinical Study ID

NCT06325345

22-5277

Ages 18-80
All Genders

Study 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:

Is gut-directed hypnotherapy an efficacious treatment for IBS symptoms among individuals with EDS or G-HSD?
Does gut-directed hypnotherapy improve other gut symptoms, quality of life, visceral sensitivity, and emotional distress?
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?

All participants will be asked to meet with a gastroenterologist three times as part of the standard medical therapy. At each physician visit, they will undergo electrocardiogram recording and complete self-report measures of gastrointestinal symptoms, quality of life, visceral sensitivity, and emotional distress. Participants randomized to receive gut-directed hypnotherapy will also eight weekly remotely-delivered sessions of gut-directed hypnotherapy delivered by a trained behavioral therapist in between the first and second physician visit. At each session of gut-directed hypnotherapy, 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 also include 30 minutes of education on the nature of the gut-brain axis and hypnotherapy prior to hypnosis.

Researchers will compare study groups to see if participants who engaged in gut-directed hypnotherapy had greater improvement in IBS symptoms, other gastrointestinal symptoms, quality of life, visceral sensitivity, and emotional distress. Exploratory analyses will examine the relationships among heart rate variability, an index of parasympathetic nervous system activity, and study outcomes.

Eligibility Criteria

Inclusion

Inclusion Criteria:

Physician diagnosis of Ehlers-Danlos Syndrome or Generalized Hypermobility SpectrumDisorder
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 weeksprior to study enrollment

Exclusion

Exclusion Criteria:

Patients with diagnosed lower bowel disease (e.g. inflammatory bowel disease, celiac'sdisease)
Patients with history of major gastrointestinal surgery (except appendectomy and/orcholecystectomy > 6 months prior to enrollment)
Patients with limited comprehension of English or hearing difficulty who would not beable 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)

Study Design

Standard Medical Therapy

April 01, 2024

April 01, 2025

Connect with a study center

Toronto General Hospital
Toronto, Ontario M5G 2C4
Canada
Site Not Available

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