Ulcerative Colitis Relapse Prevention Trial, Hypnosis

Study Overview
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Brief Summary
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The UCRPT is a randomized controlled trial to determine if a type of hypnotherapy will maintain remission in patients affected by Ulcerative Colitis.

Detailed Description
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The purpose of the study is to determine whether hypnotherapy can serve as an effective therapy for patients with Ulcerative Colitis (UC), a chronic, relapsing and remitting inflammatory bowel disease (IBD). The goal of this study is to determine if mind-body therapy is an effective complementary therapy for IBD, meaning a therapy to be used in conjunction with your standard treatment provided by your gastroenterologist. Standard treatment for UC often includes a combination approach and may include medications such as mesalamine, corticosteroids or immunomodulators. Mind-body therapy or hypnosis has been used to reduce stress and subsequent disease activity in patients with gastrointestinal diseases including IBD and Irritable Bowel Syndrome. It has also been shown to improve immune function and reduce inflammation in other health conditions such as cancer and arthritis. In this study, patients with inactive UC will be randomized to one of three groups. Two groups will undergo one of two mind-body therapies, which may include relaxation techniques or other techniques aimed at identifying the impact of UC on your psyche along with standard care for their UC. The other group will undergo 8 weeks of standard care without mind-body therapy. Clinical assessment measures will be repeated at 8 weeks, 12 weeks, 24 weeks and 52 weeks.

Official Title
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National Center for Complementary & Alternative Medicine, The Role of Gut-Directed Hypnotherapy in Relapse Prevention for Ulcerative Colitis

Conditions
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Ulcerative Colitis, Inflammatory Bowel Disease

Intervention / Treatment
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* Behavioral: Hypnotherapy
* Behavioral: Standard care
* Behavioral: Mind Body Therapy


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: male and female patients between the ages of 18 and 70 of any ethnicity endoscopy-confirmed (within the past 2 years) mild or moderately severe Ulcerative Colitis (at time of previous flare) inactive disease at the time of recruitment: Mayo score <2 with no subscale >1 no rectal bleeding Physician Global Assessment Score (PGA) = 0 2 weeks of baseline daily symptom diaries that support criteria for inactive disease documented disease flare within the past 1.5 years to enhance the opportunity to observe differences between groups in a 1-year trial . no medication or a stable dose of maintenance medication (i.e. mesalamine or sulfasalazine) for at least one month prior to enrollment. If taking maintenance medication: an increase in dose will be considered a relapse If taking no medication: initiation of any medication will be considered a relapse Exclusion Criteria: active disease daily rectal bleeding for past 7 days Mayo Score > 2, any subscale > 1 PGA score >0 history of severe or fulminant UC most recent flare included > 6 bloody stools a day history of of toxicity including fever, tachycardia, anemia or an elevated Erythrocyte sedimentation rate (ESR) ∙ history of continuous bleeding, blood transfusion requirement, abdominal tenderness and distension, and colonic dilation on abdominal plain films other gastrointestinal conditions Crohn's Disease (CD) short-bowel syndrome celiac sprue irritable bowel syndrome (IBS) renal or hepatic disease positive stool exam (bacteria, ova, parasites) C-difficile history of colon resection steroid-dependent, patients taking oral steroids within the past 30 days, topical steroids within the past week, quit smoking in the past 30 days given the known effects of smoking cessation on UC disease flare 23. contraindications for hypnotherapy unresolved history of physical or sexual abuse a current or past dissociative disorder (i.e. Borderline PD, PTSD) history of psychosis (including mania) history of psychiatric hospitalization, including for self-harm or SI/HI current substance abuse severe psychiatric disorder patients who are resistant to hypnosis as a result of religious or moral beliefs or any other reason

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 70 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Hypnotherapy<br> | Behavioral: Hypnotherapy<br>* 8 weeks of gut-directed hypnotherapy<br>* Other names: HYP;|
| Placebo Comparator: Standard care<br> | Behavioral: Standard care<br>* 8 weeks of standard of care<br>* Other names: SC;|
| Placebo Comparator: Mind Body Therapy<br> | Behavioral: Mind Body Therapy<br>* 8 weeks of mind-body therapy<br>* Other names: MB;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| feasibility |  | 52 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Estimated effect sizes |  | 52 weeks | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Hypnotherapy, Ulcerative Colitis, Inflammatory Bowel Disease, Gastrointestinal Diseases, Digestive System Diseases, Intestinal Diseases, Colonic Diseases