Functional Dyspepsia Hypnosis

January 28, 2022 updated by: Sarah Kinsinger

Self-Administered Hypnotherapy for Functional Dyspepsia

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Actual)

23

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Illinois
      • Maywood, Illinois, United States, 60153
        • Loyola University Medical Center

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

14 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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)

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
12 weeks
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")
12 weeks
Satisfaction With Web Platform
Time Frame: 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".
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
Time Frame: 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.
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.
Time Frame: 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.
Baseline, 3 months
The Visceral Anxiety Index (VSI) Will be Used to Assess Changes in Gastrointestinal Specific Anxiety.
Time Frame: 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.
Baseline, 3 months
The Brief Symptom Inventory (BSI) Will be Used to Assess Changes in Psychological Distress.
Time Frame: 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.
Baseline, 3 months
Changes in Outpatient Physician Consultation Following Hypnotherapy Treatment.
Time Frame: 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
Baseline, 12 weeks
Number of Medications Used for Functional Dyspepsia
Time Frame: 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.
Baseline, 12 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sarah Kinsinger

Investigators

  • Principal Investigator: Sarah Kinsinger, PhD, Loyola University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

May 3, 2019

Primary Completion (Actual)

November 3, 2020

Study Completion (Actual)

November 3, 2020

Study Registration Dates

First Submitted

March 19, 2019

First Submitted That Met QC Criteria

March 19, 2019

First Posted (Actual)

March 21, 2019

Study Record Updates

Last Update Posted (Actual)

April 1, 2022

Last Update Submitted That Met QC Criteria

January 28, 2022

Last Verified

January 1, 2022

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 211673

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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