UnknownNot Applicable

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

Canada74 participantsStarted 2024-04-01

Plain-language 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. Is gut-directed hypnotherapy an efficacious treatment for IBS symptoms among individuals with EDS or G-HSD? 2. Does gut-directed hypnotherapy improve other gut symptoms, quality of life, visceral sensitivity, and emotional distress? 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? 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.

Who can participate

Age range

18 Years – 80 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

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)

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

IBS Symptom Severity

Timeframe: Immediately post-treatment, 3-months post-treatment

Trial details

NCT IDNCT06325345

SponsorUniversity Health Network, Toronto

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2024-12-29

Contact for this trial

Misbah Salim Salim

4166035800 misbah.salim@uhn.ca

View on ClinicalTrials.gov More Ehlers-Danlos Syndrome trials