Home Hypnotherapy for Refractory Functional Chest Pain: A Pilot Study
试验速览
- 阶段
- 不适用
- 状态
- 终止
- 入组人数
- 8
- 试验地点
- 2
- 主要终点
- Global change in chest pain at the 12 weeks
研究概览
简要总结
The primary aim is to develop and test the feasibility of a standardized digital audio home-hypnotherapy (HHT) program for patients with refractory functional chest pain (FCP).
The secondary aims of this study are:
- To obtain pilot data to assess the magnitude of the treatment effect of self-hypnosis in refractory FCP for an anticipated future, larger treatment trial;
- To determine the stability of the treatment effect of HHT in refractory FCP;
- To assess the relationship between response to HHT and psychological factors; and
- To assess the relationship between response to HHT and symptomatic dimensions of chest pain (severity, frequency, and duration).
- To assess the difference
详细描述
Eligible patients with refractory FCP will be randomized to one of 2 arms: the active treatment group, who will receive the HHT program; or a control group. Patients in the active treatment group will receive the 12-week digital audio HHT program. This protocol consists of 7 sessions, each approximately 30-40 minutes, administered every 2 weeks, for a cumulative 12 weeks of treatment, along with a shorter (approximately 12 minute) session administered daily. Patients in the control group will receive a digital audio educational program. Subjects in both groups will be assessed at baseline, 4-6 weeks into treatment, at the end of the treatment, and 3 months after conclusion of the program. Global change in symptoms will be assessed with a 7-point Likert scale. Patients will be considered to respond if they have significant improvement on the Likert scale at the post-treatment visit. Patients will complete a chest pain symptom diary, the SCL-90 and the Coping Strategies Questionnaire-Catastrophizing subscale to assess psychological features, and the SF-36 as a measure of Health Related Quality of Life (HRQOL).
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
- •Age 18 to 80, male or female.
- •Patients must fulfill the Rome III criteria for Functional Chest Pain of Presumed Esophageal Origin for the previous 3 months (with symptom onset at least 6 months before diagnosis), including all of the following:
- •Midline chest pain or discomfort that is not of burning quality
- •Absence of evidence that gastroesophageal reflux is the cause of the symptom
- •Absence of histopathology-based esophageal motility disorders
- •Persistent symptoms despite a trial of antidepressant therapy, as defined by either:
- •chest pain despite at least a continuous 4-week trial of at least one antidepressant within the last 6 months; or
- •intolerance of at least one antidepressant within the last 6 months.
- •Negative cardiac evaluation (negative cardiac stress test or negative coronary angiogram)
- •Negative gastrointestinal evaluation for cause of the pain, defined by absence of Los Angeles grade C or D erosive esophagitis on endoscopy, persistent chest pain on PPI therapy, and no association of chest pain with reflux episodes on an ambulatory pH or pH-impedance study, defined as a symptom index <50% or symptom association probability <95% for chest pain .
排除标准
- •Severe co-morbid illness (cardiac, pulmonary, renal, hematologic, hepatic)
- •Prior treatment with hypnosis/hypnotherapy for a medical condition
- •Prior major thoracic surgery
- •Prior diagnosis of or treatment for dissociative disorders, post-traumatic stress disorder, borderline personality disorder, or other psychiatric disorders that include psychotic features
- •Pregnancy or planned pregnancy within the upcoming 3 months
- •Inability or unwillingness to give informed consent
结局指标
主要结局
Global change in chest pain at the 12 weeks
时间窗: 12 Weeks Post Treatment Start
To fulfill Rome III recommendations for the design of treatment trials for Functional Gastrointestinal Disorders (FGIDS),47 we will use a 7-point Likert scale to assess for global change in chest pain. At times V2, V3, and V4, patients will be asked the following question: "Compared to before starting this therapy, how would you rate your chest pain?" The following answers will be given as options: "much better" (+3), "somewhat better" (+2), "minimally better" (+1), "no change" (0), "minimally worse" (-1), "somewhat worse" (-2), "much worse" (-3).
次要结局
- Global change in chest pain at 4 weeks(4 Weeks Post Treatment Start)
- Global change in chest pain at 6 weeks(6 Weeks Post Treatment Start)
- Change in symptom score at 3 months(12 Weeks Post Treatment Start)
- Change in psychometric score at 3 months(12 Weeks Post Treatment Start)
- Change in HRQOL scores at 3 months(12 Weeks Post Treatment Start)
研究者
Ryan Madanick, MD
Assistant Professor of Medicine Director, UNC Gastroenterology & Hepatology Fellowship Program
University of North Carolina, Chapel Hill