NCT06325345

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

Status unknown NA Last updated 22 March 2024

What this trial tests

NA trial testing Gut-directed hypnotherapy in Ehlers-Danlos Syndrome in 74 participants. Status unknown.

Timeline

1 April 2024

Primary endpoint
29 December 2024

1 April 2025

Quick facts

Lead sponsor	University Health Network, Toronto
Phase	NA
Status	Status unknown
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	none
Primary purpose	treatment
Enrollment	74
Start date	1 April 2024
Primary completion	29 December 2024
Estimated completion	1 April 2025
Sites	1 location across Canada

Drugs / interventions tested

• Gut-directed hypnotherapy
• Standard Medical Therapy — full drug profile →

Conditions studied

• Ehlers-Danlos Syndrome — all drugs for Ehlers-Danlos Syndrome →
• Irritable Bowel Syndrome — all drugs for Irritable Bowel Syndrome →
• Hypermobility Syndrome — all drugs for Hypermobility Syndrome →
• Gastrointestinal Dysfunction — all drugs for Gastrointestinal Dysfunction →

Sponsor

University Health Network, Toronto

Who can join

Adults 18 to 80, any sex, with Ehlers-Danlos Syndrome or Irritable Bowel Syndrome. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

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.

Publications & conference data

No peer-reviewed publications indexed yet for this trial.