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Clinical Hypnosis in Pediatric Crohn's Disease (HypnoCrohns)

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ClinicalTrials.gov Identifier: NCT03809195
Recruitment Status : Recruiting
First Posted : January 18, 2019
Last Update Posted : February 22, 2019
Sponsor:
Information provided by (Responsible Party):
Amanda Lee, Vanderbilt University Medical Center

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.


Condition or disease Intervention/treatment Phase
Pediatric Crohns Disease Behavioral: Clinical Hypnosis Not Applicable

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 40 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description: intervention group versus control group
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Clinical Hypnosis in Pediatric Crohn's Disease
Actual Study Start Date : February 14, 2019
Estimated Primary Completion Date : January 2020
Estimated Study Completion Date : May 2020

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Crohn's Disease

Arm Intervention/treatment
Experimental: Hypnosis Intervention
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
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.

No Intervention: Waitlist Control
This group will serve as a control comparison and be offered the intervention after control data collection is complete.



Primary Outcome Measures :
  1. IMPACT-III [ Time Frame: Change from baseline to 8 weeks. ]
    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.

  2. Modified Cantril Ladder [ Time Frame: Change from baseline to 8 weeks. ]
    Single item quality of life measure. From 0 to 10, with 10 representing the best quality of life.

  3. PedsQL 4.0 Generic Core Scale, Parent Proxy [ Time Frame: Change from baseline to 8 weeks. ]
    "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.


Secondary Outcome Measures :
  1. PROMIS Pediatric Anxiety, short form [ Time Frame: Change from baseline to 8 weeks. ]
    PROMIS stands for Patient-Reported Outcomes Measurement Information System. This measure is 8 items each scored from 1 to 5 points, with the lowest possible raw score being 8 and the highest possible raw score being 40. Higher scores indicate greater anxiety, i.e. worse. The raw score is translated into a T-score. The T-score rescales the raw score into a standardized T-score with a mean of 50 and a standard deviation (SD) of 10. Therefore, a person with a T-score of 40 is one SD below the mean.

  2. PROMIS Pediatric Depressive Symptoms, short form [ Time Frame: Change from baseline to 8 weeks. ]
    PROMIS stands for Patient-Reported Outcomes Measurement Information System. This measure is 8 items each scored from 1 to 5 points, with the lowest possible raw score being 8 and the highest possible raw score being 40. Higher scores indicate greater depressive symptoms, i.e. worse. The raw score is translated into a T-score. The T-score rescales the raw score into a standardized T-score with a mean of 50 and a standard deviation (SD) of 10. Therefore, a person with a T-score of 40 is one SD below the mean.

  3. PROMIS Pediatric Sleep Disturbance, short form [ Time Frame: Change from baseline to 8 weeks. ]
    PROMIS stands for Patient-Reported Outcomes Measurement Information System. This measure is 8 items each scored from 1 to 5 points, with the lowest possible raw score being 8 and the highest possible raw score being 40. Higher scores indicate greater sleep disturbance, i.e. worse sleep. The raw score is translated into a T-score. The T-score rescales the raw score into a standardized T-score with a mean of 50 and a standard deviation (SD) of 10. Therefore, a person with a T-score of 40 is one SD below the mean.

  4. Pain Beliefs Questionnaire, short form [ Time Frame: Change from baseline to 8 weeks. ]
    This is an 18-item measure designed assess youth's beliefs about their abdominal pain. It is comprised of three subscales each with 6 items—Pain Threat, Problem-Focused Coping Efficacy (PFCE), and Emotion-Focused Coping Efficacy (EFCE). The respondent rates each item on how true the statement is for them on a 5-point scale ranging from 0 ("not at all true") to 4 ("very true"). Subscale scores are computed by averaging the items pertaining to each subscale. For Pain Threat, higher score indicates stronger beliefs that one's pain represents a personal threat. For the PFCE and EFCE subscales, higher scores indicate a stronger belief in one's ability to cope with pain.

  5. Abdominal Pain Intensity [ Time Frame: Change from baseline to 8 weeks. ]
    Two items combined for a total score, range from 0 to 20, with higher scores representing greater pain intensity. Each item rated on a scale from 0 (no pain) to 10 (most possible pain). The first item assesses the respondent's worst pain in the past week, and the second item assesses the usual intensity of the pain experienced during the past week. Adapted from the Abdominal Pain Index, with permission.

  6. Healthcare utilization [ Time Frame: Change from baseline to 8 weeks. ]
    By parent report, total number of contacts health care provider for their child in the past 8 weeks, other than previously scheduled check-ups, including emergency department visits, urgent care visits, and phone calls or messages to the doctor's office

  7. School absences [ Time Frame: Change from baseline to 8 weeks. ]
    By parent report, number of days of school the child has missed in the past 8 weeks (choices: 0, 1-3, 4-6, 7-10, more than 10 days). If on school break, parent asked to estimate as if school was in session--for example, how many days the child had to miss usual activities.

  8. Abdominal Pain Frequency [ Time Frame: Change from baseline to 8 weeks. ]
    How many days did the respondent experience pain in the past week, with options being never, 1-2 days, 3-4 days, 5-6 days, or daily, with greater frequency of pain being worse. Adapted from the Abdominal Pain Index, with permission.


Other Outcome Measures:
  1. IMPACT-III [ Time Frame: Change from baseline to secondary time point at 16 weeks. ]
    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.

  2. PedsQL 4.0 Generic Core Scale, Parent Proxy [ Time Frame: Change from baseline to secondary time point at 16 weeks. ]
    "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.

  3. Modified Cantril Ladder [ Time Frame: change over time monitored weekly for 8 weeks then at secondary time point at 16 weeks ]
    Single item quality of life measure. From 0 to 10, with 10 representing the best quality of life.



Information from the National Library of Medicine

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Ages Eligible for Study:   12 Years to 18 Years   (Child, Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • 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.

Exclusion Criteria:

  • 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.

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): NCT03809195


Contacts
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Contact: Amanda D Lee, MD 954-612-5896 amanda.d.lee@vumc.org
Contact: Lynn Walker, PhD lynn.walker@vumc.org

Locations
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United States, Tennessee
Vanderbilt University Medical Center Recruiting
Nashville, Tennessee, United States, 37232
Contact: Amanda D Lee, MD    954-612-5896    amanda.d.lee@vumc.org   
Contact: Lynn Walker, PhD       lynn.walker@vumc.org   
Sub-Investigator: Alexandra Russell, MD         
Sub-Investigator: Sari Acra, MD MPH         
Sub-Investigator: Dedrick Moulton, MD         
Sub-Investigator: Lindsey Mckernan, PhD         
Sponsors and Collaborators
Vanderbilt University Medical Center
Investigators
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Principal Investigator: Amanda D Lee, MD Vanderbilt University Medical Center

Publications:

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Responsible Party: Amanda Lee, Clinical Fellow, Vanderbilt University Medical Center
ClinicalTrials.gov Identifier: NCT03809195    
Other Study ID Numbers: 181436
First Posted: January 18, 2019    Key Record Dates
Last Update Posted: February 22, 2019
Last Verified: February 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 Amanda Lee, Vanderbilt University Medical Center:
hypnosis
inflammatory bowel disease
mind-body
brain-gut
hypnotherapy
quality of life
psychosocial
Additional relevant MeSH terms:
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Crohn Disease
Inflammatory Bowel Diseases
Gastroenteritis
Gastrointestinal Diseases
Digestive System Diseases
Intestinal Diseases