Functional Dyspepsia Hypnosis
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|ClinicalTrials.gov Identifier: NCT03884270|
Recruitment Status : Recruiting
First Posted : March 21, 2019
Last Update Posted : June 16, 2020
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.
|Condition or disease||Intervention/treatment||Phase|
|Functional Dyspepsia||Behavioral: Hypnotherapy||Not Applicable|
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.
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||23 participants|
|Intervention Model:||Single Group Assignment|
|Intervention Model Description:||This is a non-randomized observational study designed|
|Masking:||None (Open Label)|
|Official Title:||Self-Administered Hypnotherapy for Functional Dyspepsia|
|Actual Study Start Date :||May 3, 2019|
|Estimated Primary Completion Date :||December 2020|
|Estimated Study Completion Date :||December 2020|
7 sessions of on-line hypnotherapy treatment over the course of 12 weeks (1 new session every 2 weeks)
7 sessions of self-administered gut-directed hypnotherapy for functional dyspepsia
- Percent of Participants that Complete the Hypnotherapy Program [ Time Frame: 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.
- Treatment Satisfaction [ Time Frame: 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")
- Satisfaction with Web Platform [ Time Frame: 12 weeks ]At the end of treatment, patients will be asked an open-ended question to obtain feedback on their experience using the web-based platform for treatment ("Please describe any difficulties you had using the web interface and/or suggestions on ways we could improve the website").
- The Patient Assessment of Upper Gastrointestinal Symptom Severity Index (PAGI-SYM) will be used to assess changes in Functional Dyspepsia Symptoms [ Time Frame: Baseline, 6 weeks, 12 weeks, and 24 weeks ]The PAGI-SYM is a 20-item self-report measure of functional dyspepsia symptom severity. The scale consists of 6 subscales (heartburn/regurgitation, nausea/vomiting, postprandial fullness/early satiety, bloating, upper abdominal pain, and lower abdominal pain). Each item is measured by a 6-point Likert scale ranging from 0 (none or absent) to 5 (very severe). Subscale scores are calculated by averaging across items comprising the subscale with higher score representing more severe symptoms.
- The Short Form Nepean Dyspepsia Index (NDI-SF) will be used to assess changes in quality of life related to functional dyspepsia. [ Time Frame: Baseline, 6 weeks, 12 weeks, and 24 weeks ]The NDI-SF is a 10-item self-report disease specific quality of life questionnaire. The scale consists of 5 sub-scales (tension/anxiety, interference with daily activities, disruption to regular eating/drinking, knowledge towards/control over disease, interference with work/study). Each item is measured by a 5-point Likert scale ranging from 0 (not applicable) to 4 (extremely). Individual items are aggregated to obtain a total score ranging from 0 to 100 with higher scores indicating greater impairment in quality of life.
- The Visceral Anxiety Index (VSI) will be used to assess changes in gastrointestinal specific anxiety. [ Time Frame: Baseline, 6 weeks, 12 weeks, and 24 weeks ]The VSI is a 15-item self-report questionnaire with responses ranging from 1 (strongly agree) to 6 (strongly disagree). The VSI is reverse scored (i.e., 1-6 becomes 5- 0) and totaled to yield a range of scores from 0 (no anxiety) to 75 (severe anxiety).
- The Brief Symptom Inventory (BSI) will be used to assess changes in psychological distress. [ Time Frame: Baseline, 6 weeks, 12 weeks, and 24 weeks ]The BSI is an 18-item self-report questionnaire with responses on a 5-point Likert scale, ranging from 0 (not bothered by a symptom at all) to 4 (extremely bothered). Three subscales are calculated (somatization, depression, and anxiety) and the subscales can be aggregated to calculate an overall global psychological distress score. The overall score and subscale scores are converted to T-scores with higher T-scores indicating more psychological distress and T-scores ≥63 indicating clinically significant psychological distress.
- Changes in outpatient physician consultation following hypnotherapy treatment. [ Time Frame: Baseline, 12 weeks, 24 weeks ]Patients will be asked to report the number of outpatient visits and procedures they have had within the last 3 months related to their functional dyspepsia symptoms.
- Percent of patients using medications for functional dyspepsia following hypnotherapy treatment. [ Time Frame: Baseline, 12 weeks, 24 weeks ]Patients will be asked to report any medications they are taking related to their functional dyspepsia symptoms.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03884270
|Contact: Sarah Kinsinger, PhD||7082160464||Sarah.Kinsinger@lumc.edu|
|United States, Illinois|
|Loyola University Medical Center||Recruiting|
|Maywood, Illinois, United States, 60153|
|Contact: Sarah Kinsinger, PhD 708-216-0464 firstname.lastname@example.org|
|Principal Investigator:||Sarah Kinsinger, PhD||Loyola University|