Clinical trial NCT03809195: Clinical Hypnosis in Pediatric Crohn's Disease
Official title: Clinical Hypnosis in Pediatric Crohn's Disease
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Pediatric Crohns Disease
Keywords: hypnosis
inflammatory bowel disease
mind-body
brain-gut
hypnotherapy
quality of life
psychosocial
Lead sponsor: Vanderbilt University Medical Center
Sponsor class: OTHER
First posted: 2019-01-18
Enrollment: 40
Sex: ALL
Minimum age (years): 12
Maximum age (years): 18
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: intervention group versus control group
Primary purpose: TREATMENT

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.


Eligibility 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.

Primary outcomes:
measure: IMPACT-III
timeFrame: Change from baseline to 8 weeks.
measure: Modified Cantril Ladder
timeFrame: Change from baseline to 8 weeks.
measure: PedsQL 4.0 Generic Core Scale, Parent Proxy
timeFrame: Change from baseline to 8 weeks.
Secondary outcomes:
measure: PROMIS Pediatric Anxiety, short form
timeFrame: Change from baseline to 8 weeks.
measure: PROMIS Pediatric Depressive Symptoms, short form
timeFrame: Change from baseline to 8 weeks.
measure: PROMIS Pediatric Sleep Disturbance, short form
timeFrame: Change from baseline to 8 weeks.
measure: Pain Beliefs Questionnaire, short form
timeFrame: Change from baseline to 8 weeks.
measure: Abdominal Pain Intensity
timeFrame: Change from baseline to 8 weeks.
measure: Healthcare utilization
timeFrame: Change from baseline to 8 weeks.
measure: School absences
timeFrame: Change from baseline to 8 weeks.
measure: Abdominal Pain Frequency
timeFrame: Change from baseline to 8 weeks.
Other outcomes:
measure: IMPACT-III
timeFrame: Change from baseline to secondary time point at 16 weeks.
measure: PedsQL 4.0 Generic Core Scale, Parent Proxy
timeFrame: Change from baseline to secondary time point at 16 weeks.
measure: Modified Cantril Ladder
timeFrame: change over time monitored weekly for 8 weeks then at secondary time point at 16 weeks
Locations:
city: Nashville
country: United States
facility: Vanderbilt University Medical Center
state: Tennessee
Study officials:
affiliation: Vanderbilt University Medical Center
name: Amanda D Lee, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.
citation: 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.
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