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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:
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Standard Medical Therapy | Other | 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 | Experimental | 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. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Gut-directed hypnotherapy | Behavioral | Eight session gut-directed hypnotherapy for IBS symptoms adapted from the evidence-based Manchester protocol for treatment of IBS. |
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| Measure | Description | Time Frame |
|---|---|---|
| IBS Symptom Severity | 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 | Immediately post-treatment, 3-months post-treatment |
| Measure | Description | Time Frame |
|---|---|---|
| Upper Gastrointestinal Symptoms | 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. | Immediately post-treatment, 3-months post-treatment |
| Measure | Description | Time Frame |
|---|---|---|
| Weekly Ratings of GI Health and Medication Use | Participants will rate upper abdominal pain, lower abdominal pain, abdominal distension, excess wind, disturbance in bowel movement, nausea, and vomiting on a scale from 0, no symptoms, to 10, severe symptoms. Participants will also rate their well-being over the past week on a scale from 0, no well-being, to 10, the most well-being possible. Participants will also be asked to report their opioid and cannabis use over the past week. |
Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Misbah Salim Salim | Contact | 4166035800 | 7887 | misbah.salim@uhn.ca |
| Name | Affiliation | Role |
|---|---|---|
| Louis Liu | University Health Network, Toronto | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Toronto General Hospital | Toronto | Ontario | M5G 2C4 | Canada |
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| Standard Medical Therapy | Other | Standard medical treatment will be administered by board certified gastroenterologists |
|
| IBS-related Quality of Life |
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. |
| Immediately post-treatment, 3-months post-treatment |
| Visceral Sensitivity | 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. | Immediately post-treatment, 3-months post-treatment |
| Emotional Distress | 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. | Immediately post-treatment, 3-months post-treatment |
| Once a week for 9 weeks hypnotherapy treatment |
| ID | Term |
|---|---|
| D004535 | Ehlers-Danlos Syndrome |
| D043183 | Irritable Bowel Syndrome |
| ID | Term |
|---|---|
| D020141 | Hemostatic Disorders |
| D014652 | Vascular Diseases |
| D002318 | Cardiovascular Diseases |
| D006474 | Hemorrhagic Disorders |
| D006402 | Hematologic Diseases |
| D006425 | Hemic and Lymphatic Diseases |
| D012868 | Skin Abnormalities |
| D000013 | Congenital Abnormalities |
| D009358 | Congenital, Hereditary, and Neonatal Diseases and Abnormalities |
| D012873 | Skin Diseases, Genetic |
| D030342 | Genetic Diseases, Inborn |
| D003095 | Collagen Diseases |
| D003240 | Connective Tissue Diseases |
| D017437 | Skin and Connective Tissue Diseases |
| D012871 | Skin Diseases |
| D003109 | Colonic Diseases, Functional |
| D003108 | Colonic Diseases |
| D007410 | Intestinal Diseases |
| D005767 | Gastrointestinal Diseases |
| D004066 | Digestive System Diseases |
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