Clinical Hypnosis in Pediatric Crohn's Disease

NCT03809195 | Completed

• 1 other identifier: 181436
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 1

Brief Summary

Inflammatory bowel disease (IBD), which includes Crohn's disease (CD) and ulcerative colitis (UC), is a chronic, immune-mediated disease increasingly prevalent in youth. Patients with IBD experience pain, fatigue, altered bowel habits, psychological distress, and reduced quality of life. Regardless of disease activity, persistent pain and psychiatric comorbidities both have a negative impact on quality of life. Alongside standard pharmacologic and nutritional therapies, clinical hypnosis is a complementary therapy that may improve physical and psychosocial outcomes in these patients. Clinical hypnosis consists of guiding the patient into a relaxed and focused state and providing therapeutic suggestions to induce desired physiologic and psychologic change. Children and adolescents are excellent candidates for hypnosis by virtue of their vivid imaginations. Hypnosis is effective in management of functional abdominal pain, irritable bowel syndrome, anxiety, chronic pain, and distress related to medical procedures. To date, there are no clinical trials that evaluate the effects of hypnosis in pediatric patients with IBD, but there is strong conceptual support for its role in improving pain and psychological distress in these patients. In addition to genetic, environmental, and microbial influences, a growing body of evidence supports the role of a dysregulated brain-gut axis and chronic stress in IBD. Animal and human studies demonstrate the effect of stress on the immune system and gastrointestinal tract. Studies show that the benefits of hypnosis may extend to its role in increasing vagal tone and regulating the immune system via the brain-gut axis. Adults with UC receiving a hypnosis intervention demonstrated improved remission and decreased inflammatory markers. Case series suggest that children with inflammatory bowel disease benefit from hypnosis, and it can be safely and easily delivered via audio recordings. Patients with IBD are interested in integrative therapies to reduce symptoms and improve quality of life, and a biopsychosocial approach is essential in their care. The addition of hypnosis may improve outcomes through influence on stress, inflammation, coping, symptom perception, and quality of life. The investigators hypothesize that pediatric patients with CD participating in a clinical hypnosis intervention as an adjunct to standard of care will report improved quality of life compared to a waitlist control group. The specific aims of the study are as follows: (1) To implement hypnosis as an adjunctive therapy in adolescents with CD. (2) To evaluate the impact of hypnosis in CD on measures of quality of life. (3) To evaluate the impact of hypnosis in CD on pain, depression, anxiety, sleep, and coping.

Conditions

Pediatric Crohns Disease

Keywords

hypnosis; inflammatory bowel disease; mind-body; brain-gut; hypnotherapy; quality of life; psychosocial

Outcome Measures

Primary Outcomes (3)

• IMPACT-III

  Pediatric inflammatory bowel disease-specific health-related quality of life measure. "IMPACT" is not an abbreviation, but rather the name of the scale. Minimum score 0 to maximum score 100, with higher signifying better quality of life. Subjects get a total score (0 to 100) and a score for each of six subscales (0 to 100): Bowel Symptoms (7 items), Treatment/Interventions (3 items), Social Functioning (12 items), Emotional Functioning (7 items), Body Image (3 items), Systemic Symptoms (3 items). Each of the 35 total items has five multiple choice options and is given a score of 0, 25, 50, 75, or 100 points. The subscale scores are an average of the scores for each item that corresponds to that subscale. The total score is an average of all item scores.

  Change from baseline to 8 weeks.

• Modified Cantril Ladder

  Single item quality of life measure. From 0 to 10, with 10 representing the best quality of life.

  Change from baseline to 8 weeks.

• PedsQL 4.0 Generic Core Scale, Parent Proxy

  "PedsQL" refers to Pediatric Quality of Life. This is a pediatric 23-item measure of health-related quality of life. Questions fall under one of five domains: Physical Functioning (8 items), Emotional Functioning (5), Social Functioning (5 items), School Functioning (5 items). Yields a total score and two summary scores-Physical Health (comprised of physical functioning domain) and Psychosocial Health (comprised of each item in the 5-item emotional, social, and school functioning domains). Each item is rated on a 5-point Likert scale. Total score and the two summary scores are linearly transformed into a 0 to 100 point scale, with higher scores representing better quality of life.

  Change from baseline to 8 weeks.

Secondary Outcomes (8)

• PROMIS Pediatric Anxiety, short form

  Change from baseline to 8 weeks.

• PROMIS Pediatric Depressive Symptoms, short form

  Change from baseline to 8 weeks.

• PROMIS Pediatric Sleep Disturbance, short form

  Change from baseline to 8 weeks.

• Pain Beliefs Questionnaire, short form

  Change from baseline to 8 weeks.

• Abdominal Pain Intensity

  Change from baseline to 8 weeks.

Other Outcomes (3)

• IMPACT-III

  Change from baseline to secondary time point at 16 weeks.

• PedsQL 4.0 Generic Core Scale, Parent Proxy

  Change from baseline to secondary time point at 16 weeks.

• Modified Cantril Ladder

  change over time monitored weekly for 8 weeks then at secondary time point at 16 weeks

Study Arms (2)

Hypnosis Intervention

EXPERIMENTAL

The intervention is clinical hypnosis--a single in-person session followed by instructions to listen to audio recordings at home. The sessions consist of the provider's voice guiding the participant into a relaxed and focused state and providing therapeutic suggestions--for example, to replace discomfort with a more pleasant sensation, to ease anxiety, and to increase energy.

Behavioral: Clinical Hypnosis

Waitlist Control

NO INTERVENTION

This group will serve as a control comparison and be offered the intervention after control data collection is complete.

Interventions

Clinical Hypnosis BEHAVIORAL

See information in arm/group description. Four different audio recordings are provided electronically, each approximately 20 minutes in length. Participants are encouraged to listen to one daily.

Hypnosis Intervention

Eligibility Criteria

• Age: 12 Years - 18 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• Patients diagnosed with Crohn's disease at least 3 months prior to enrollment
• Inactive, mild, or moderate disease activity by Improve Care Now Physician's Global Assessment (ICN PGA) at most recent GI clinic visit
• Ages 12-18 years at time of enrollment
• English-speaking and with the normal cognitive development required to understand the verbal instructions/suggestions provided in the hypnosis session/audio recordings and to understand and complete the written surveys
• Has daily access to an electronic device (ex. smartphone, computer) that can receive text messages or e-mail, on which online surveys can be completed, and on which the participant can access and listen to audio recordings.

You may not qualify if:

• Patients diagnosed with Crohn's disease less than 3 months prior to enrollment
• Severe disease activity per ICN PGA at most recent GI clinic visit
• Age \< 12 years or \> 18 years
• Non-English speaking or having a cognitive disability that precludes understanding the verbal instructions/suggestions provided in the hypnosis session/audio recordings and the completion of written surveys
• Lacks daily access to an electronic device (ex. smartphone, computer) that can receive text messages or e-mail, on which online surveys can be completed, and on which the participant can access and listen to audio recordings.

Sponsors & Collaborators

• Vanderbilt University Medical Center: lead

Study Sites (1)

Vanderbilt University Medical Center

Nashville, Tennessee, 37232, United States

Location

Related Publications (9)

• Stone AL, Walker LS, Laird KT, Shirkey KC, Smith CA. Pediatric Pain Beliefs Questionnaire: Psychometric Properties of the Short Form. J Pain. 2016 Sep;17(9):1036-44. doi: 10.1016/j.jpain.2016.06.006. Epub 2016 Jun 27.

  PMID: 27363626 BACKGROUND

• Forrest CB, Meltzer LJ, Marcus CL, de la Motte A, Kratchman A, Buysse DJ, Pilkonis PA, Becker BD, Bevans KB. Development and validation of the PROMIS Pediatric Sleep Disturbance and Sleep-Related Impairment item banks. Sleep. 2018 Jun 1;41(6). doi: 10.1093/sleep/zsy054.

  PMID: 29546286 BACKGROUND

• Zhang YZ, Li YY. Inflammatory bowel disease: pathogenesis. World J Gastroenterol. 2014 Jan 7;20(1):91-9. doi: 10.3748/wjg.v20.i1.91.

  PMID: 24415861 BACKGROUND

• Mackner LM, Greenley RN, Szigethy E, Herzer M, Deer K, Hommel KA. Psychosocial issues in pediatric inflammatory bowel disease: report of the North American Society for Pediatric Gastroenterology, Hepatology, and Nutrition. J Pediatr Gastroenterol Nutr. 2013 Apr;56(4):449-58. doi: 10.1097/MPG.0b013e3182841263.

  PMID: 23287808 BACKGROUND

• Kunz JH, Hommel KA, Greenley RN. Health-related quality of life of youth with inflammatory bowel disease: a comparison with published data using the PedsQL 4.0 generic core scales. Inflamm Bowel Dis. 2010 Jun;16(6):939-46. doi: 10.1002/ibd.21128.

  PMID: 19998462 BACKGROUND

• Vlieger AM, Menko-Frankenhuis C, Wolfkamp SC, Tromp E, Benninga MA. Hypnotherapy for children with functional abdominal pain or irritable bowel syndrome: a randomized controlled trial. Gastroenterology. 2007 Nov;133(5):1430-6. doi: 10.1053/j.gastro.2007.08.072. Epub 2007 Sep 2.

  PMID: 17919634 BACKGROUND

• 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.

  PMID: 26264539 BACKGROUND

• Bonaz BL, Bernstein CN. Brain-gut interactions in inflammatory bowel disease. Gastroenterology. 2013 Jan;144(1):36-49. doi: 10.1053/j.gastro.2012.10.003. Epub 2012 Oct 12.

  PMID: 23063970 BACKGROUND

• Tiles-Sar N, Neuser J, de Sordi D, Baltes A, Preiss JC, Moser G, Timmer A. Psychological interventions for treatment of inflammatory bowel disease. Cochrane Database Syst Rev. 2025 Apr 17;4(4):CD006913. doi: 10.1002/14651858.CD006913.pub3.

  PMID: 40243391 DERIVED

MeSH Terms

Conditions

Inflammatory Bowel Diseases

Interventions

Hypnosis

Condition Hierarchy (Ancestors)

Gastroenteritis; Gastrointestinal Diseases; Digestive System Diseases; Intestinal Diseases

Intervention Hierarchy (Ancestors)

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

Study Officials

• Amanda D Lee, MD

  Vanderbilt University Medical Center

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Clinical Fellow

Model Details: intervention group versus control group

Study Record Dates

• First Submitted: January 3, 2019
• First Posted: January 18, 2019
• Study Start: February 14, 2019
• Primary Completion: September 30, 2019
• Study Completion: May 1, 2020
• Last Updated: May 28, 2020

Record last verified: 2020-05

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)