Clinical trial NCT06325345: RCT of Gut-directed Hypnotherapy in Ehlers-Danlos Syndromes and Generalized Hypermobility Spectrum Disorders
Official title: A Randomized Controlled Trial of Gut-directed Hypnotherapy for Treatment of Irritable Bowel Syndrome in Ehlers-Danlos Syndromes and Generalized Hypermobility Spectrum Disorders
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: Ehlers-Danlos Syndrome
Irritable Bowel Syndrome
Hypermobility Syndrome
Gastrointestinal Dysfunction
Lead sponsor: University Health Network, Toronto
Sponsor class: OTHER
First posted: 2024-03-22
Enrollment: 74
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


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)

Primary outcomes:
measure: IBS Symptom Severity
timeFrame: Immediately post-treatment, 3-months post-treatment
Secondary outcomes:
measure: Upper Gastrointestinal Symptoms
timeFrame: Immediately post-treatment, 3-months post-treatment
measure: IBS-related Quality of Life
timeFrame: Immediately post-treatment, 3-months post-treatment
measure: Visceral Sensitivity
timeFrame: Immediately post-treatment, 3-months post-treatment
measure: Emotional Distress
timeFrame: Immediately post-treatment, 3-months post-treatment
Other outcomes:
measure: Weekly Ratings of GI Health and Medication Use
timeFrame: Once a week for 9 weeks hypnotherapy treatment
Locations:
city: Toronto
country: Canada
facility: Toronto General Hospital
state: Ontario
Study officials:
affiliation: University Health Network, Toronto
name: Louis Liu
role: PRINCIPAL_INVESTIGATOR
References: