Functional Dyspepsia Hypnosis

NCT03884270 | Completed Results

• 1 other identifier: 211673
• Study Type: interventional
• Target: 23
• Locations: 1 country
• Sites: 1

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.

Conditions

Functional Dyspepsia

Keywords

functional dyspepsia; hypnotherapy; functional gastrointestinal disorders

Outcome Measures

Primary Outcomes (3)

• 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 Outcomes (6)

• 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 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 Visceral Anxiety Index (VSI) Will be Used to Assess Changes in Gastrointestinal Specific Anxiety.

  Baseline, 3 months

• The Brief Symptom Inventory (BSI) Will be Used to Assess Changes in Psychological Distress.

  Baseline, 3 months

• Changes in Outpatient Physician Consultation Following Hypnotherapy Treatment.

  Baseline, 12 weeks

Study Arms (1)

Hypnotherapy

EXPERIMENTAL

7 sessions of on-line hypnotherapy treatment over the course of 12 weeks (1 new session every 2 weeks)

Behavioral: Hypnotherapy

Interventions

Hypnotherapy BEHAVIORAL

7 sessions of self-administered gut-directed hypnotherapy for functional dyspepsia

Hypnotherapy

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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)

Sponsors & Collaborators

• Sarah Kinsinger: lead

Study Sites (1)

Loyola University Medical Center

Maywood, Illinois, 60153, United States

Location

Related Publications (28)

• Ford AC, Marwaha A, Sood R, Moayyedi P. Global prevalence of, and risk factors for, uninvestigated dyspepsia: a meta-analysis. Gut. 2015 Jul;64(7):1049-57. doi: 10.1136/gutjnl-2014-307843. Epub 2014 Aug 21.

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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.

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• 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.

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• 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. doi: 10.1053/gast.2002.37071.

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• 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.

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• 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.

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• 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.

  PMID: 23642981 BACKGROUND

• 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. doi: 10.4166/kjg.2011.57.2.67. Korean.

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• Hamilton J, Guthrie E, Creed F, Thompson D, Tomenson B, Bennett R, Moriarty K, Stephens W, Liston R. A randomized controlled trial of psychotherapy in patients with chronic functional dyspepsia. Gastroenterology. 2000 Sep;119(3):661-9. doi: 10.1053/gast.2000.16493.

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• 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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MeSH Terms

Conditions

Gastrointestinal Diseases

Interventions

Hypnosis

Condition Hierarchy (Ancestors)

Digestive System Diseases

Intervention Hierarchy (Ancestors)

Mind-Body Therapies; Complementary Therapies; Therapeutics; Psychotherapy; Behavioral Disciplines and Activities

Results Point of Contact

• Title: Dr. Sarah Kinsinger
• Organization: Loyola University Chicago

sarah.kinsinger@lumc.edu

708-216-0464

Study Officials

• Sarah Kinsinger, PhD

  Loyola University

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Associate Professor of Medicine

Model Details: This is a non-randomized observational study designed

Study Record Dates

• First Submitted: March 19, 2019
• First Posted: March 21, 2019
• Study Start: May 3, 2019
• Primary Completion: November 3, 2020
• Study Completion: November 3, 2020
• Last Updated: April 1, 2022
• Results First Posted: April 1, 2022

Record last verified: 2022-01

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)