Functional Dyspepsia Hypnosis

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

Official Title
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Self-Administered Hypnotherapy for Functional Dyspepsia

Conditions
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Functional Dyspepsia

Intervention / Treatment
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* Behavioral: Hypnotherapy


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: 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. Exclusion Criteria: 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)

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Interventional Model Description: This is a non-randomized observational study designed
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Hypnotherapy<br>7 sessions of on-line hypnotherapy treatment over the course of 12 weeks (1 new session every 2 weeks) | Behavioral: Hypnotherapy<br>* 7 sessions of self-administered gut-directed hypnotherapy for functional dyspepsia<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Percent of Participants That Complete the Hypnotherapy Program | 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. | 12 weeks | 
| Treatment Satisfaction | 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) | 12 weeks | 
| Satisfaction With Web Platform | 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. | 12 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The Patient Assessment of Upper Gastrointestinal Symptom Severity Index (PAGI-SYM) Will be Used to Assess Changes in Functional Dyspepsia Symptoms | 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 (no complaints) to 5 (severe complaints). Subscale scores are calculated by taking the mean of the items in each subscale. The total score is calculated by taking the mean of the subscale scores. Total scores range from 0 to 5, with higher scores indicating worse symptoms. The PAGI-SYM total score was regressed on the fixed effect of time period in a linear mixed effects regression model that included random intercepts to account for within-participant correlation. Least square mean differences were calculated as 3-month follow-up minus baseline. | 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. | 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 NDI-SF score was regressed on the fixed effect of time period in a linear mixed effects regression model that included random intercepts to account for within-participant correlation. Least square mean differences were calculated as 3-month follow-up minus baseline. | Baseline, 3 months | 
| The Visceral Anxiety Index (VSI) Will be Used to Assess Changes in Gastrointestinal Specific Anxiety. | The VSI is a 15-item self-report questionnaire with responses ranging from 1 (strongly agree) to 6 (strongly disagree). The raw VSI score ranges from 0 (severe anxiety) to 75 (no anxiety). The VSI score was regressed on the fixed effect of time period in a linear mixed effects regression model that included random intercepts to account for within-participant correlation. Least square mean differences were calculated as 3-month follow-up minus baseline. | Baseline, 3 months | 
| The Brief Symptom Inventory (BSI) Will be Used to Assess Changes in Psychological Distress. | 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 a population mean of 50 and a standard deviation of 10). Higher T-scores indicate more psychological distress and T-scores ≥63 indicate clinically significant psychological distress. The BSI score was regressed on the fixed effect of time period in a linear mixed effects regression model that included random intercepts to account for within-participant correlation. Least square mean differences were calculated as 3-month follow-up minus baseline. | Baseline, 3 months | 
| Changes in Outpatient Physician Consultation Following Hypnotherapy Treatment. | At both baseline and end of treatment, 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 | Baseline, 12 weeks | 
| Number of Medications Used for Functional Dyspepsia | At baseline and end of treatment, patients will be asked to report any medications they are taking related to their functional dyspepsia symptoms. | Baseline, 12 weeks | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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functional dyspepsia, hypnotherapy, functional gastrointestinal disorders