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

Not Applicable

Not yet recruiting

• Conditions: Ehlers-Danlos Syndrome; Hypermobility Syndrome; Irritable Bowel Syndrome; Gastrointestinal Dysfunction
• Interventions: Other: Standard Medical Therapy; Behavioral: Gut-directed hypnotherapy

• Registration Number: NCT06325345
• Lead Sponsor: University Health Network, Toronto

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. 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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2023-02-08
• Status Verified: 2024-02
• Study First Submitted QC: 2024-03-15
• Last Update Submitted: 2024-03-15
• Study First Posted: 2024-03-22
• Last Update Posted: 2024-03-22
• Study Start: 2024-04-01
• Primary Completion: 2024-12-29
• Study Completion: 2025-04-01

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: All
• Target Recruitment: 74

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

Read More

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)

Read More

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Standard Medical Therapy	Standard Medical Therapy	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.
Standard Medical Therapy plus Gut-Directed Hypnotherapy	Standard Medical Therapy	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.
Standard Medical Therapy plus Gut-Directed Hypnotherapy	Gut-directed hypnotherapy	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.

Primary Outcome Measures

Name	Time	Method
IBS Symptom Severity	Immediately post-treatment, 3-months post-treatment	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

Secondary Outcome Measures

Name	Time	Method
Upper Gastrointestinal Symptoms	Immediately post-treatment, 3-months post-treatment	Upper gastrointestinal symptoms will be measured using the Patient Assessment of Upper Gastrointestinal Symptoms (PAGI-SYM), a commonly used 20-item self-report measure of upper gastrointestinal symptoms with good reliability and construct validity.
Visceral Sensitivity	Immediately post-treatment, 3-months post-treatment	Visceral sensitivity will be evaluated by the Visceral Sensitivity Index (VSI). a 15-item measure developed to assess gastrointestinal specific anxiety. Visceral sensitivity has been identified as an important contributor to IBS symptom severity and a treatment target for IBS treatment. The VSI has excellent psychometric properties.
Emotional Distress	Immediately post-treatment, 3-months post-treatment	Emotional Distress will be measured using the 8-item anxiety symptom and 8-item depressive symptom self-report measures from the Patient Reported Outcome Measurement Information System (PROMIS), which are extensively validated an have previously been used in IBS research.
IBS-related Quality of Life	Immediately post-treatment, 3-months post-treatment	IBS-related Quality of Life will be assessed using The Irritable Bowel Syndrome Quality of Life scale, a 34-item, psychometrically valid self-report measure of IBS-related QOL.

Trial Locations

Locations (1)

Toronto General Hospital; 🇨🇦 Toronto, Ontario, Canada