Gut-directed Hypnotherapy for IBS in Ehlers-Danlos Syndrome

Overseen By Misbah Salim Salim

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: University Health Network, Toronto

Disqualifiers: Lower bowel disease, Major GI surgery, Serious mental illness, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: 3

Duration: 9 weeks

74 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

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 Is on the Research Team?

Louis Liu

Principal Investigator

University Health Network, Toronto

Are You a Good Fit for This Trial?

This trial is for individuals with Ehlers-Danlos Syndromes or Generalized Hypermobility Spectrum Disorders who also have Irritable Bowel Syndrome. They must be on a stable IBS medication dose for 4 weeks before joining and able to understand English well. People with certain bowel diseases, major gut surgery history, serious mental illness, cognitive issues, or heavy alcohol use cannot participate.

Inclusion Criteria

I have been diagnosed with Ehlers-Danlos Syndrome or Generalized Hypermobility Spectrum Disorder.

My doctor diagnosed me with Irritable Bowel Syndrome.

I have been on a stable dose of my IBS medication for at least 4 weeks.

Exclusion Criteria

Patients with a known history of serious mental illness (e.g., schizophrenia, dissociative identity disorder)

I have cognitive issues that affect my understanding.

Patients with limited comprehension of English or hearing difficulty who would not be able to understand the verbal instructions for clinical hypnosis

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive standard medical therapy, with some receiving additional gut-directed hypnotherapy over eight weekly sessions

9 weeks

3 visits (in-person), 8 sessions (virtual)

Follow-up

Participants are monitored for safety and effectiveness after treatment

3 months

What Are the Treatments Tested in This Trial?

Interventions

• Gut-directed hypnotherapy

Trial Overview The study tests if gut-directed hypnotherapy plus standard medical therapy improves IBS symptoms in patients with EDS/G-HSD compared to standard therapy alone. Participants will either receive regular doctor visits or the same visits plus eight sessions of hypnotherapy aimed at relaxing the gut and improving its function.

How Is the Trial Designed?

Group I: Standard Medical Therapy plus Gut-Directed Hypnotherapy Experimental Treatment 2 Interventions

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.

Group II: Standard Medical Therapy Experimental Treatment 1 Intervention

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.

Who Is Running the Clinical Trial?

University Health Network, Toronto

Lead Sponsor

Trials

1,555

Recruited

526,000+