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Trial record 3 of 41 for:    Recruiting, Not yet recruiting, Available Studies | Dyspepsia

Functional Dyspepsia Hypnosis

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ClinicalTrials.gov Identifier: NCT03884270
Recruitment Status : Recruiting
First Posted : March 21, 2019
Last Update Posted : May 9, 2019
Sponsor:
Information provided by (Responsible Party):
Sarah Kinsinger, Loyola University

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.


Condition or disease Intervention/treatment Phase
Functional Dyspepsia Behavioral: Hypnotherapy Not Applicable

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.


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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)
Primary Purpose: Treatment
Official Title: Self-Administered Hypnotherapy for Functional Dyspepsia
Actual Study Start Date : May 3, 2019
Estimated Primary Completion Date : April 2020
Estimated Study Completion Date : April 2020

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Indigestion

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




Primary Outcome Measures :
  1. 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.

  2. 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")

  3. 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").


Secondary Outcome Measures :
  1. 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.

  2. 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.

  3. 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).

  4. 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.

  5. 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.

  6. 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.



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

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)

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03884270


Contacts
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Contact: Sarah Kinsinger, PhD 7082160464 Sarah.Kinsinger@lumc.edu

Locations
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United States, Illinois
Loyola University Medical Center Recruiting
Maywood, Illinois, United States, 60153
Contact: Sarah Kinsinger, PhD    708-216-0464    sarah.kinsinger@lumc.edu   
Sponsors and Collaborators
Sarah Kinsinger
Investigators
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Principal Investigator: Sarah Kinsinger, PhD Loyola University

Publications:

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Responsible Party: Sarah Kinsinger, Associate Professor of Medicine, Loyola University
ClinicalTrials.gov Identifier: NCT03884270     History of Changes
Other Study ID Numbers: 211673
First Posted: March 21, 2019    Key Record Dates
Last Update Posted: May 9, 2019
Last Verified: May 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Sarah Kinsinger, Loyola University:
functional dyspepsia
hypnotherapy
functional gastrointestinal disorders
Additional relevant MeSH terms:
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Dyspepsia
Signs and Symptoms, Digestive
Signs and Symptoms