Functional Dyspepsia Hypnosis

• ClinicalTrials.gov Identifier: NCT03884270
• Recruitment Status: Enrolling by invitation
• First Posted: March 21, 2019
• Last Update Posted: August 11, 2020
• Sponsor: Sarah Kinsinger
• Information provided by (Responsible Party): Sarah Kinsinger, Loyola University

Study Description

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.

Study Design

• Study Type: Interventional (Clinical Trial)
• Actual Enrollment: 23 participants
• Allocation: N/A
• 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: December 2020
• Estimated Study Completion Date: December 2020

Arms and Interventions

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

Outcome Measures

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.

Eligibility Criteria

• 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)

Contacts and Locations

Locations

United States, Illinois

Loyola University Medical Center

Maywood, Illinois, United States, 60153

Sponsors and Collaborators

Sarah Kinsinger

Investigators

• Principal Investigator: Sarah Kinsinger, PhD; Loyola University

More Information

Publications:

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Stanghellini V, Chan FK, Hasler WL, Malagelada JR, Suzuki H, Tack J, Talley NJ. Gastroduodenal Disorders. Gastroenterology. 2016 May;150(6):1380-92. doi: 10.1053/j.gastro.2016.02.011. Review.

Ford AC, Forman D, Bailey AG, Axon AT, Moayyedi P. Initial poor quality of life and new onset of dyspepsia: results from a longitudinal 10-year follow-up study. Gut. 2007 Mar;56(3):321-7. Epub 2006 Aug 14.

Camilleri M, Stanghellini V. Current management strategies and emerging treatments for functional dyspepsia. Nat Rev Gastroenterol Hepatol. 2013 Mar;10(3):187-94. doi: 10.1038/nrgastro.2013.11. Epub 2013 Feb 5. Review. Erratum in: Nat Rev Gastroenterol Hepatol. 2013 Jun;10(6):320.

Palsson OS. Hypnosis Treatment of Gastrointestinal Disorders: A Comprehensive Review of the Empirical Evidence. Am J Clin Hypn. 2015 Oct;58(2):134-58. doi: 10.1080/00029157.2015.1039114. Review.

Chiarioni G, Vantini I, De Iorio F, Benini L. Prokinetic effect of gut-oriented hypnosis on gastric emptying. Aliment Pharmacol Ther. 2006 Apr 15;23(8):1241-9.

Calvert EL, Houghton LA, Cooper P, Morris J, Whorwell PJ. Long-term improvement in functional dyspepsia using hypnotherapy. Gastroenterology. 2002 Dec;123(6):1778-85.

Orive M, Barrio I, Orive VM, Matellanes B, Padierna JA, Cabriada J, Orive A, Escobar A, Quintana JM. A randomized controlled trial of a 10 week group psychotherapeutic treatment added to standard medical treatment in patients with functional dyspepsia. J Psychosom Res. 2015 Jun;78(6):563-8. doi: 10.1016/j.jpsychores.2015.03.003. Epub 2015 Mar 11.

Faramarzi M, Azadfallah P, Book HE, Rasolzadeh Tabatabai K, Taherim H, Kashifard M. The effect of psychotherapy in improving physical and psychiatric symptoms in patients with functional dyspepsia. Iran J Psychiatry. 2015;10(1):43-9.

Kawata H, Oka T. [The use of psychotropic drugs for functional gastrointestinal disorders: are they beneficial?]. Nihon Rinsho. 2012 Jan;70(1):84-8. Review. Japanese.

Faramarzi M, Azadfallah P, Book HE, Tabatabaei KR, Taheri H, Shokri-shirvani J. A randomized controlled trial of brief psychoanalytic psychotherapy in patients with functional dyspepsia. Asian J Psychiatr. 2013 Jun;6(3):228-34. doi: 10.1016/j.ajp.2012.12.012. Epub 2013 Feb 15.

Jee SR, Jung HK, Min BH, Choi KD, Rhee PL, Kang YW, Lee SI; Korean Society of Neurogastroenterology and Motility. [Guidelines for the treatment of functional dyspepsia]. Korean J Gastroenterol. 2011 Feb;57(2):67-81. Korean.

Hjelland IE, Svebak S, Berstad A, Flatabø G, Hausken T. Breathing exercises with vagal biofeedback may benefit patients with functional dyspepsia. Scand J Gastroenterol. 2007 Sep;42(9):1054-62.

Haag S, Senf W, Tagay S, Langkafel M, Braun-Lang U, Pietsch A, Heuft G, Talley NJ, Holtmann G. Is there a benefit from intensified medical and psychological interventions in patients with functional dyspepsia not responding to conventional therapy? Aliment Pharmacol Ther. 2007 Apr 15;25(8):973-86.

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Palsson OS, Turner MJ, Whitehead WE. Hypnosis home treatment for irritable bowel syndrome: a pilot study. Int J Clin Exp Hypn. 2006 Jan;54(1):85-99.

van Tilburg MA, Chitkara DK, Palsson OS, Turner M, Blois-Martin N, Ulshen M, Whitehead WE. Audio-recorded guided imagery treatment reduces functional abdominal pain in children: a pilot study. Pediatrics. 2009 Nov;124(5):e890-7. doi: 10.1542/peds.2009-0028. Epub 2009 Oct 12.

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Rentz AM, Kahrilas P, Stanghellini V, Tack J, Talley NJ, de la Loge C, Trudeau E, Dubois D, Revicki DA. Development and psychometric evaluation of the patient assessment of upper gastrointestinal symptom severity index (PAGI-SYM) in patients with upper gastrointestinal disorders. Qual Life Res. 2004 Dec;13(10):1737-49.

Talley NJ, Verlinden M, Jones M. Validity of a new quality of life scale for functional dyspepsia: a United States multicenter trial of the Nepean Dyspepsia Index. Am J Gastroenterol. 1999 Sep;94(9):2390-7.

Talley NJ, Tack J, Ptak T, Gupta R, Giguère M. Itopride in functional dyspepsia: results of two phase III multicentre, randomised, double-blind, placebo-controlled trials. Gut. 2008 Jun;57(6):740-6. Epub 2007 Oct 26.

Talley NJ, Verlinden M, Jones M. Quality of life in functional dyspepsia: responsiveness of the Nepean Dyspepsia Index and development of a new 10-item short form. Aliment Pharmacol Ther. 2001 Feb;15(2):207-16.

Labus JS, Mayer EA, Chang L, Bolus R, Naliboff BD. The central role of gastrointestinal-specific anxiety in irritable bowel syndrome: further validation of the visceral sensitivity index. Psychosom Med. 2007 Jan;69(1):89-98.

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• Responsible Party: Sarah Kinsinger, Associate Professor of Medicine, Loyola University
• ClinicalTrials.gov Identifier: NCT03884270
• Other Study ID Numbers: 211673
• First Posted: March 21, 2019
• Last Update Posted: August 11, 2020
• Last Verified: August 2020

Individual Participant Data (IPD) Sharing Statement:

• Plan to Share IPD: No

• 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:

Dyspepsia; Signs and Symptoms, Digestive