Self-Administered Hypnotherapy for Functional Dyspepsia
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 23
- 试验地点
- 2
- 主要终点
- Treatment Satisfaction
研究概览
简要总结
The purpose of this study is to evaluate the efficacy of a hypnotherapy treatment program for functional dyspepsia that can be self-administered using on-line audio recordings. This is a non-randomized study. All patients will receive 7 sessions of hypnotherapy treatment administered over a 12-week period.
The primary objective of the study is to determine the feasibility and acceptability of the self-administered hypnotherapy program. The secondary objective is to evaluate the effect of the treatment on participant reported symptom severity, quality of life, anxiety and depression.
详细描述
Functional dyspepsia (FD) is a very common health problem characterized by epigastric pain and/or postprandial fullness with no evidence of structural disease to explain the symptoms. There are few effective treatment options for FD, with medications having limited efficacy for the condition.
The goal of the current study is to test a 7-session hypnotherapy treatment specifically targeting symptoms of functional dyspepsia. The intervention will be provided via the Internet with pre-recorded audio files. In this trial, 23 adults diagnosed with functional dyspepsia in accordance with the Rome IV criteria will be included. Patients will meet with a licensed health psychologist for an initial study visit to determine their eligibility for hypnotherapy treatment. Following this screening visit, patients will receive an email with information for accessing the password-protected online platform where they will complete pre-treatment assessment forms and access treatment materials. Participants will complete baseline questionnaire data prior to beginning the hypnotherapy sessions and follow-up questionnaires at mid-treatment (6 weeks), post-treatment (12 weeks) and 3 months post-treatment. Participants will complete a new hypnotherapy session every 2 weeks over the course of 3 months and utilize a shorter, practice session 5 times per week.
The primary aim of the study is to assess feasibility and acceptability of the online treatment program by assessing the percentage of patients who log in to the web interface, utilize the materials sufficiently, complete the 12 week program, and report at least average satisfaction with the treatment. The secondary aim is to determine treatment effectiveness by measuring changes in pre- to post- treatment scores on a self-report functional dyspepsia symptom severity index (Patient Assessment of Upper Gastrointestinal Symptom Severity Index; PAGI-SYM). Additional endpoints include changes in pre- to post- treatment scores on a measure of disease-specific quality of life and psychological indices.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Diagnosis of functional dyspepsia by a gastroenterologist
- •Meeting ROME IV diagnostic criteria for functional dyspepsia
- •At least 18 yrs of age (no upper age limit)
- •Able to give informed consent
- •English speaking
- •Have daily personal access to the Internet via laptop or desktop computer, tablet or a smartphone.
排除标准
- •Concomitant organic gastrointestinal disease
- •Diagnosed or presenting with serious mental illness (e.g., eating disorder, schizophrenia, psychosis, obsessive-compulsive disorder, post-traumatic stress disorder, or a dissociative disorder)
- •Cognitive or language barriers that make completion of questionnaires difficult or limit understanding of a verbal intervention (hypnosis)
结局指标
主要结局
Treatment Satisfaction
时间窗: 12 weeks
Treatment satisfaction will be assessed with a single item at the end of treatment asking how satisfied they were overall with their assigned treatment (on a 7-point scale from "Extremely dissatisfied" to "Extremely satisfied")
Percent of Participants That Complete the Hypnotherapy Program
时间窗: 12 weeks
Feasibility will be calculated as the proportion of participants who complete the hypnotherapy treatment program in comparison to those who drop out before treatment is completed.
Satisfaction With Web Platform
时间窗: 12 weeks
At the end of treatment, patients were asked an open-ended question to obtain feedback on their experience using the web-based platform for treatment. They were asked to rate their difficulty using the web platform on a 7-point scale from "Extremely difficult" to "Extremely easy".
次要结局
- The Patient Assessment of Upper Gastrointestinal Symptom Severity Index (PAGI-SYM) Will be Used to Assess Changes in Functional Dyspepsia Symptoms(Baseline, 3-months)
- The Brief Symptom Inventory (BSI) Will be Used to Assess Changes in Psychological Distress.(Baseline, 3 months)
- The Short Form Nepean Dyspepsia Index (NDI-SF) Will be Used to Assess Changes in Quality of Life Related to Functional Dyspepsia.(Baseline, 3 months)
- The Visceral Anxiety Index (VSI) Will be Used to Assess Changes in Gastrointestinal Specific Anxiety.(Baseline, 3 months)
- Changes in Outpatient Physician Consultation Following Hypnotherapy Treatment.(Baseline, 12 weeks)
- Number of Medications Used for Functional Dyspepsia(Baseline, 12 weeks)
研究者
Sarah Kinsinger
Associate Professor of Medicine
Loyola University