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Ulcerative Colitis Relapse Prevention Trial, Hypnosis (UCRPT)

Primary Purpose

Ulcerative Colitis, Inflammatory Bowel Disease

Status

Completed

Phase

Not Applicable

Locations

United States

Study Type

Interventional

Intervention

Hypnotherapy

Standard care

Mind Body Therapy

About this trial

This is an interventional prevention trial for Ulcerative Colitis focused on measuring Hypnotherapy, Ulcerative Colitis, Inflammatory Bowel Disease, Gastrointestinal Diseases, Digestive System Diseases, Intestinal Diseases, Colonic Diseases

Eligibility Criteria

18 Years - 70 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

Northwestern University, Feinberg School of Medicine

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Active Comparator

Placebo Comparator

Arm Label

Hypnotherapy

Standard care

Mind Body Therapy

Arm Description

Outcomes

Primary Outcome Measures

feasibility

Secondary Outcome Measures

Estimated effect sizes

Full Information

NCT ID

NCT00798642

First Posted

November 25, 2008

Last Updated

April 1, 2014

Sponsor

Northwestern University

Collaborators

National Center for Complementary and Integrative Health (NCCIH)

1. Study Identification

Unique Protocol Identification Number

NCT00798642

Brief Title

Ulcerative Colitis Relapse Prevention Trial, Hypnosis

Acronym

UCRPT

Official Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

April 2014

Overall Recruitment Status

Completed

Study Start Date

July 2007 (undefined)

Primary Completion Date

November 2011 (Actual)

Study Completion Date

June 2012 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

Northwestern University

Collaborators

National Center for Complementary and Integrative Health (NCCIH)

4. Oversight

Data Monitoring Committee

Yes

5. Study Description

Brief Summary

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

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Ulcerative Colitis, Inflammatory Bowel Disease

Keywords

Hypnotherapy, Ulcerative Colitis, Inflammatory Bowel Disease, Gastrointestinal Diseases, Digestive System Diseases, Intestinal Diseases, Colonic Diseases

7. Study Design

Primary Purpose

Prevention

Study Phase

Not Applicable

Interventional Study Model

Parallel Assignment

Masking

None (Open Label)

Allocation

Randomized

Enrollment

55 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Hypnotherapy

Arm Type

Active Comparator

Arm Title

Standard care

Arm Type

Placebo Comparator

Arm Title

Mind Body Therapy

Arm Type

Placebo Comparator

Intervention Type

Behavioral

Intervention Name(s)

Hypnotherapy

Other Intervention Name(s)

HYP

Intervention Description

8 weeks of gut-directed hypnotherapy

Intervention Type

Behavioral

Intervention Name(s)

Standard care

Other Intervention Name(s)

Intervention Description

8 weeks of standard of care

Intervention Type

Behavioral

Intervention Name(s)

Mind Body Therapy

Other Intervention Name(s)

Intervention Description

8 weeks of mind-body therapy

Primary Outcome Measure Information:

Title

feasibility

Time Frame

52 weeks

Secondary Outcome Measure Information:

Title

Estimated effect sizes

Time Frame

52 weeks

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Maximum Age & Unit of Time

70 Years

Accepts Healthy Volunteers

Eligibility Criteria

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

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Laurie Keefer, PhD

Organizational Affiliation

Northwestern University

Official's Role

Principal Investigator

Facility Information:

Facility Name

Northwestern University, Feinberg School of Medicine

City

Chicago

State/Province

Illinois

ZIP/Postal Code

60611

Country

United States

12. IPD Sharing Statement

Citations:

PubMed Identifier

23957526

Citation

Keefer L, Taft TH, Kiebles JL, Martinovich Z, Barrett TA, Palsson OS. Gut-directed hypnotherapy significantly augments clinical remission in quiescent ulcerative colitis. Aliment Pharmacol Ther. 2013 Oct;38(7):761-71. doi: 10.1111/apt.12449. Epub 2013 Aug 19.

Results Reference

derived

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Ulcerative Colitis Relapse Prevention Trial, Hypnosis

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