A Randomized Controlled Trial of Gut-directed Hypnotherapy for Treatment of Irritable Bowel Syndrome in Ehlers-Danlos Syndromes and Generalized Hypermobility Spectrum Disorders
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 入组人数
- 74
- 试验地点
- 2
- 主要终点
- IBS Symptom Severity
研究概览
简要总结
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:
- Is gut-directed hypnotherapy an efficacious treatment for IBS symptoms among individuals with EDS or G-HSD?
- Does gut-directed hypnotherapy improve other gut symptoms, quality of life, visceral sensitivity, and emotional distress?
- 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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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
排除标准
- •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)
研究组 & 干预措施
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.
干预措施: Standard Medical Therapy (Other)
Standard Medical Therapy plus 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.
干预措施: Gut-directed hypnotherapy (Behavioral)
Standard Medical Therapy plus 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.
干预措施: Standard Medical Therapy (Other)
结局指标
主要结局
IBS Symptom Severity
时间窗: 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
次要结局
- Upper Gastrointestinal Symptoms(Immediately post-treatment, 3-months post-treatment)
- Visceral Sensitivity(Immediately post-treatment, 3-months post-treatment)
- Emotional Distress(Immediately post-treatment, 3-months post-treatment)
- IBS-related Quality of Life(Immediately post-treatment, 3-months post-treatment)