NCT00798642

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
55

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Jul 2007

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

July 1, 2007

Completed
1.4 years until next milestone

First Submitted

Initial submission to the registry

November 25, 2008

Completed
1 day until next milestone

First Posted

Study publicly available on registry

November 26, 2008

Completed
2.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 1, 2011

Completed
7 months until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2012

Completed
Last Updated

April 2, 2014

Status Verified

April 1, 2014

Enrollment Period

4.3 years

First QC Date

November 25, 2008

Last Update Submit

April 1, 2014

Conditions

Ulcerative ColitisInflammatory Bowel Disease

Keywords

HypnotherapyUlcerative ColitisInflammatory Bowel DiseaseGastrointestinal DiseasesDigestive System DiseasesIntestinal DiseasesColonic Diseases

Outcome Measures

Primary Outcomes (1)

  • feasibility

    52 weeks

Secondary Outcomes (1)

  • Estimated effect sizes

    52 weeks

Study Arms (3)

Hypnotherapy

ACTIVE COMPARATOR
Behavioral: Hypnotherapy

Standard care

PLACEBO COMPARATOR
Behavioral: Standard care

Mind Body Therapy

PLACEBO COMPARATOR
Behavioral: Mind Body Therapy

Interventions

HypnotherapyBEHAVIORAL

8 weeks of gut-directed hypnotherapy

Also known as: HYP
Hypnotherapy
Standard careBEHAVIORAL

8 weeks of standard of care

Also known as: SC
Standard care
Mind Body TherapyBEHAVIORAL

8 weeks of mind-body therapy

Also known as: MB
Mind Body Therapy

Eligibility Criteria

Age18 Years - 70 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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
  • 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

You may not qualify if:

  • 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
  • +10 more criteria

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Northwestern University, Feinberg School of Medicine

Chicago, Illinois, 60611, United States

Location

Related Publications (2)

  • Tiles-Sar N, Neuser J, de Sordi D, Baltes A, Preiss JC, Moser G, Timmer A. Psychological interventions for treatment of inflammatory bowel disease. Cochrane Database Syst Rev. 2025 Apr 17;4(4):CD006913. doi: 10.1002/14651858.CD006913.pub3.

    PMID: 40243391DERIVED

  • 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.

    PMID: 23957526DERIVED

MeSH Terms

Conditions

Colitis, UlcerativeInflammatory Bowel DiseasesGastrointestinal DiseasesDigestive System DiseasesIntestinal DiseasesColonic Diseases

Interventions

HypnosisStandard of CareMind-Body Therapies

Condition Hierarchy (Ancestors)

ColitisGastroenteritis

Intervention Hierarchy (Ancestors)

Complementary TherapiesTherapeuticsPsychotherapyBehavioral Disciplines and ActivitiesQuality Indicators, Health CareQuality of Health CareHealth Services AdministrationHealth Care Quality, Access, and Evaluation

Study Officials

  • Laurie Keefer, PhD

    Northwestern University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Associate Professor

Study Record Dates

First Submitted

November 25, 2008

First Posted

November 26, 2008

Study Start

July 1, 2007

Primary Completion

November 1, 2011

Study Completion

June 1, 2012

Last Updated

April 2, 2014

Record last verified: 2014-04

Locations

US(1)