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

Launched by UNIVERSITY HEALTH NETWORK, TORONTO · Mar 15, 2024

Keywords

ClinConnect Summary

This clinical trial is studying whether gut-directed hypnotherapy can help manage symptoms of Irritable Bowel Syndrome (IBS) in people with Ehlers-Danlos Syndromes (EDS) or Generalized Hypermobility Spectrum Disorders (G-HSD). Participants will be randomly divided into two groups: one group will receive standard medical treatment, while the other group will receive the same medical care plus eight sessions of gut-directed hypnotherapy. The main goals of the study are to determine if hypnotherapy improves IBS symptoms and overall well-being, as well as to explore how the body’s relaxation system might relate to these improvements.

To be eligible for this trial, participants must have a doctor’s diagnosis of EDS or G-HSD, along with a diagnosis of IBS. They should be on a stable medication dose for IBS if they are receiving treatment. Participants will have three visits with a gastroenterologist to monitor their symptoms and health, and those in the hypnotherapy group will also attend eight weekly online sessions where they will learn relaxation techniques aimed at improving gut function. This study is not yet recruiting participants, and it’s important for potential candidates to know that certain conditions, like serious mental illness or heavy alcohol use, may exclude them from participating.

Gender

ALL

Eligibility criteria

• Inclusion Criteria:
• • 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
• Exclusion Criteria:
• • 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)