Functional Dyspepsia
Conditions
Keywords
functional dyspepsia, hypnotherapy, functional gastrointestinal disorders
Brief summary
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
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.
Interventions
BEHAVIORALHypnotherapy
7 sessions of self-administered gut-directed hypnotherapy for functional dyspepsia
Sponsors
Sarah Kinsinger
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Intervention model description
This is a non-randomized observational study designed
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
Yes
Inclusion criteria
1. Diagnosis of functional dyspepsia by a gastroenterologist 2. Meeting ROME IV diagnostic criteria for functional dyspepsia 3. At least 18 yrs of age (no upper age limit) 4. Able to give informed consent 5. English speaking 6. Have daily personal access to the Internet via laptop or desktop computer, tablet or a smartphone.
Exclusion criteria
1. Concomitant organic gastrointestinal disease 2. Diagnosed or presenting with serious mental illness (e.g., eating disorder, schizophrenia, psychosis, obsessive-compulsive disorder, post-traumatic stress disorder, or a dissociative disorder) 3. Cognitive or language barriers that make completion of questionnaires difficult or limit understanding of a verbal intervention (hypnosis)
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Percent of Participants That Complete the Hypnotherapy Program | 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 | 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 | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| The Brief Symptom Inventory (BSI) Will be Used to Assess Changes in Psychological Distress. | Baseline, 3 months | 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. |
| 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 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. |
| Number of Medications Used for Functional Dyspepsia | Baseline, 12 weeks | At baseline and end of treatment, patients will be asked to report any medications they are taking related to their functional dyspepsia symptoms. |
| Changes in Outpatient Physician Consultation Following Hypnotherapy Treatment. | Baseline, 12 weeks | 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 |
| 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 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. |
| The Visceral Anxiety Index (VSI) Will be Used to Assess Changes in Gastrointestinal Specific Anxiety. | Baseline, 3 months | 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. |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Hypnotherapy 7 sessions of on-line hypnotherapy treatment over the course of 12 weeks (1 new session every 2 weeks)
Hypnotherapy: 7 sessions of self-administered gut-directed hypnotherapy for functional dyspepsia | 23 |
| Total | 23 |
Baseline characteristics
| Characteristic | Hypnotherapy |
|---|---|
| Age, Continuous | 38 years STANDARD_DEVIATION 17 |
| Education Graduate degree | 6 Participants |
| Education High school | 3 Participants |
| Education Some college | 3 Participants |
| Education Some graduate school | 1 Participants |
| Education Technical school or associates degree | 2 Participants |
| Education Undergraduate degree | 8 Participants |
| Employment Full-time | 15 Participants |
| Employment Not working | 4 Participants |
| Employment Part-time | 2 Participants |
| Employment Retired | 2 Participants |
| Functional dyspepsia Rome Criteria met Epigastric pain syndrome only | 2 Participants |
| Functional dyspepsia Rome Criteria met Postprandial distress syndrome and epigastric pain syndrome | 10 Participants |
| Functional dyspepsia Rome Criteria met Postprandial distress syndrome only | 6 Participants |
| Prior mental health diagnosis No | 12 Participants |
| Prior mental health diagnosis Yes | 11 Participants |
| Race/Ethnicity, Customized Hispanic (any race) | 2 Participants |
| Race/Ethnicity, Customized Non-Hispanic Black/African American | 3 Participants |
| Race/Ethnicity, Customized Non-Hispanic White/Caucasian | 17 Participants |
| Race/Ethnicity, Customized Other | 1 Participants |
| Region of Enrollment United States | 23 participants |
| Relationship status Committed relationship | 6 Participants |
| Relationship status Married | 10 Participants |
| Relationship status Single | 7 Participants |
| Sex: Female, Male Female | 18 Participants |
| Sex: Female, Male Male | 5 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | 0 / 23 |
| other Total, other adverse events | 0 / 23 |
| serious Total, serious adverse events | 0 / 23 |
Outcome results
Primary
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.
Time frame: 12 weeks
Population: Participants enrolled in the study
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Hypnotherapy | Percent of Participants That Complete the Hypnotherapy Program | 22 Participants |
Primary
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.
Time frame: 12 weeks
Population: Participants enrolled in the study and completed 3-month follow-up surveys.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Hypnotherapy | Satisfaction With Web Platform | Extremely difficult | 0 Participants |
| Hypnotherapy | Satisfaction With Web Platform | Extremely easy | 17 Participants |
| Hypnotherapy | Satisfaction With Web Platform | Moderately easy | 3 Participants |
| Hypnotherapy | Satisfaction With Web Platform | Somewhat easy | 1 Participants |
| Hypnotherapy | Satisfaction With Web Platform | Neutral | 1 Participants |
| Hypnotherapy | Satisfaction With Web Platform | Somewhat difficult | 0 Participants |
| Hypnotherapy | Satisfaction With Web Platform | Moderately difficult | 0 Participants |
Primary
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)
Time frame: 12 weeks
Population: Participants enrolled in the study and completed 3-month follow-up surveys.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Hypnotherapy | Treatment Satisfaction | Extremely dissatisfied | 1 Participants |
| Hypnotherapy | Treatment Satisfaction | Very dissatisfied | 0 Participants |
| Hypnotherapy | Treatment Satisfaction | Somewhat dissatisfied | 0 Participants |
| Hypnotherapy | Treatment Satisfaction | Neutral | 2 Participants |
| Hypnotherapy | Treatment Satisfaction | Somewhat satisfied | 12 Participants |
| Hypnotherapy | Treatment Satisfaction | Very satisfied | 4 Participants |
| Hypnotherapy | Treatment Satisfaction | Extremely satisfied | 3 Participants |
Secondary
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
Time frame: Baseline, 12 weeks
Population: Participants enrolled in the study
| Arm | Measure | Group | Value (MEDIAN) |
|---|---|---|---|
| Hypnotherapy | Changes in Outpatient Physician Consultation Following Hypnotherapy Treatment. | Number of outpatient visits at baseline | 2 number of events |
| Hypnotherapy | Changes in Outpatient Physician Consultation Following Hypnotherapy Treatment. | Number of outpatient visits at end of treatment | 1 number of events |
| Hypnotherapy | Changes in Outpatient Physician Consultation Following Hypnotherapy Treatment. | Number of procedures at baseline | 2 number of events |
| Hypnotherapy | Changes in Outpatient Physician Consultation Following Hypnotherapy Treatment. | Number of procedures at end of treatment | 1 number of events |
Secondary
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.
Time frame: Baseline, 12 weeks
Population: Participants enrolled in the study
| Arm | Measure | Group | Value (MEDIAN) |
|---|---|---|---|
| Hypnotherapy | Number of Medications Used for Functional Dyspepsia | Medications taking at baseline | 1 number of medications |
| Hypnotherapy | Number of Medications Used for Functional Dyspepsia | Medications taking at end of treatment | 1 number of medications |
Secondary
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.
Time frame: Baseline, 3 months
Population: Participants enrolled in the study
| Arm | Measure | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|
| Hypnotherapy | The Brief Symptom Inventory (BSI) Will be Used to Assess Changes in Psychological Distress. | -9.22 score on a scale | Standard Error 1.34 |
Secondary
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.
Time frame: Baseline, 3-months
Population: Participants enrolled in the study.
| Arm | Measure | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|
| Hypnotherapy | The Patient Assessment of Upper Gastrointestinal Symptom Severity Index (PAGI-SYM) Will be Used to Assess Changes in Functional Dyspepsia Symptoms | -0.82 score on a scale | Standard Error 0.12 |
Secondary
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.
Time frame: Baseline, 3 months
Population: Participants enrolled in the study.
| Arm | Measure | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|
| Hypnotherapy | The Short Form Nepean Dyspepsia Index (NDI-SF) Will be Used to Assess Changes in Quality of Life Related to Functional Dyspepsia. | -9.65 score on a scale | Standard Error 1.75 |
Secondary
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.
Time frame: Baseline, 3 months
Population: Participants enrolled in the study.
| Arm | Measure | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|
| Hypnotherapy | The Visceral Anxiety Index (VSI) Will be Used to Assess Changes in Gastrointestinal Specific Anxiety. | 10.39 score on a scale | Standard Error 2.73 |