Ulcerative Colitis Relapse Prevention Trial, Hypnosis

Ulcerative Colitis Clinical Trial

— UCRPT  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00798642
• Other study ID #: R21AT003204
• Secondary ID: R21AT003204
• Status: Completed
• Phase: N/A
• First received: November 25, 2008
• Last updated: April 1, 2014
• Start date: July 2007
• Est. completion date: June 2012

Study information

• Verified date: April 2014
• Source: Northwestern University
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Federal GovernmentUnited States: Institutional Review Board
• Study type: Interventional

Clinical Trial Summary

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

Description:

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 55
• Est. completion date: June 2012
• Est. primary completion date: November 2011
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 70 Years

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Prevention

Related Conditions & MeSH terms

• Colitis
• Colitis, Ulcerative
• Inflammatory Bowel Disease
• Inflammatory Bowel Diseases
• Intestinal Diseases
• Ulcer
• Ulcerative Colitis

Intervention

Behavioral:
• Hypnotherapy
8 weeks of gut-directed hypnotherapy
• Standard care
8 weeks of standard of care
• Mind Body Therapy
8 weeks of mind-body therapy

Locations

Country	Name	City	State
United States	Northwestern University, Feinberg School of Medicine	Chicago	Illinois

Sponsors (2)

Lead Sponsor	Collaborator
Northwestern University	National Center for Complementary and Integrative Health (NCCIH)

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	feasibility		52 weeks	No
Secondary	Estimated effect sizes		52 weeks	No

External Links

•   Northwestern University, Center for Psychosocial Research in GI