Ulcerative ColitisUCRPTNCT00798642
Ulcerative Colitis Relapse Prevention Trial, Hypnosis
A study testing Hypnotherapy and Mind Body Therapy in people with Ulcerative Colitis and Inflammatory Bowel Disease, run by Northwestern University at 1 site in United States.
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. Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Ulcerative Colitis, Inflammatory Bowel Disease
- What is being tested?
- Hypnotherapy and Mind Body Therapy
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 55 participants
- Where
- 1 siteUnited States
- Study dates
- Jul 2007to Jun 2012
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
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- 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
Who cannot join
- 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
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- 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
Trial locations and contacts
1 site in 1 country.
United States1 site
Northwestern University, Feinberg School of Medicine
Chicago, Illinois, 60611
About this study
Official title: National Center for Complementary & Alternative Medicine, The Role of Gut-Directed Hypnotherapy in Relapse Prevention for Ulcerative Colitis
The UCRPT is a randomized controlled trial to determine if a type of hypnotherapy will maintain remission in patients affected by Ulcerative Colitis.
Read the 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.
- Conditions
- Ulcerative Colitis, Inflammatory Bowel Disease
- Being tested
- Hypnotherapy, Standard care, Mind Body Therapy
- Keywords
- Hypnotherapy, Ulcerative Colitis, Inflammatory Bowel Disease, Gastrointestinal Diseases, Digestive System Diseases, Intestinal Diseases, Colonic Diseases
- Medical subject headings
- Colitis, Ulcerative, Inflammatory Bowel Diseases, Gastrointestinal Diseases, Digestive System Diseases, Intestinal Diseases, Colonic Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
HypnotherapyBehavioural
Also called HYP
8 weeks of gut-directed hypnotherapy
Standard careBehavioural
Also called SC
8 weeks of standard of care
Mind Body TherapyBehavioural
Also called MB
8 weeks of mind-body therapy
| Study group | Role | What they receive |
|---|---|---|
| Hypnotherapy | Active comparator | Not described Receives: Behavioral: Hypnotherapy |
| Standard care | Placebo comparator | Not described Receives: Behavioral: Standard care |
| Mind Body Therapy | Placebo comparator | Not described Receives: Behavioral: Mind Body Therapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
feasibility
Measured: 52 weeks
Secondary outcomes (1)
Estimated effect sizes
Measured: 52 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Nov 2008 (estimated)
- Study startJul 2007
- Primary completionNov 2011
- Study completionJun 2012
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Ulcerative ColitisStudies of the same condition, open and under way.
- More trials run by Northwestern UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 55 participants (actual)
Sponsor and investigators
- Lead sponsor
- Northwestern University
- Sponsor type
- University, hospital or other
- Collaborators
- National Center for Complementary and Integrative Health (NCCIH)
- Responsible party
- Principal investigator, Laurie Keefer, Northwestern University
- Investigators
- Laurie Keefer, PhD, Principal investigator, Northwestern University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00798642
- Sponsor's protocol ID
- R21AT003204
- Other IDs
- R21AT003204
- Acronym
- UCRPT
- Status last verified
- Apr 2014
- First submitted
- 25 Nov 2008
- Last updated
- 2 Apr 2014
- Results posted
- No
- Data monitoring committee
- Yes
Publications
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.
PubMed 40243391Keefer 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.
PubMed 23957526
Study at a glance
From the registry record, last updated by the sponsor on 2 Apr 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- National Center for Complementary & Alternative Medicine, The Role of Gut-Directed Hypnotherapy in Relapse Prevention for Ulcerative Colitis
- ClinicalTrials.gov ID
- NCT00798642
- Acronym / sponsor ID
- UCRPT / R21AT003204
- Conditions
- Ulcerative Colitis, Inflammatory Bowel Disease
- Keywords
- Hypnotherapy, Ulcerative Colitis, Inflammatory Bowel Disease, Gastrointestinal Diseases, Digestive System Diseases, Intestinal Diseases, Colonic Diseases
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 55 participants (actual)
- Lead sponsor
- Northwestern UniversityUniversity, hospital or other
- Collaborators
- National Center for Complementary and Integrative Health (NCCIH)
- Study start
- Jul 2007
- Primary completion
- Nov 2011 (actual)
- Study completion
- Jun 2012 (actual)
- First posted
- 26 Nov 2008 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Hypnotherapy | Active comparator | Behavioral: Hypnotherapy |
| Standard care | Placebo comparator | Behavioral: Standard care |
| Mind Body Therapy | Placebo comparator | Behavioral: Mind Body Therapy |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (11 listed)
- 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
Key exclusion criteria (25 listed)
- active disease
- daily rectal bleeding for past 7 days
- Mayo Score > 2, any subscale > 1
- PGA score >0
- history of severe or fulminant UC
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| HypnotherapyAlso: HYP8 weeks of gut-directed hypnotherapy | Behavioural | Hypnotherapy |
| Standard careAlso: SC8 weeks of standard of care | Behavioural | Standard care |
| Mind Body TherapyAlso: MB8 weeks of mind-body therapy | Behavioural | Mind Body Therapy |
Primary outcome
feasibility
Time frame: 52 weeks
1 secondary outcome
Estimated effect sizes
Time frame: 52 weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Apr 2014.
- Derived from this study: PubMed 40243391Tiles-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.
- Derived from this study: PubMed 23957526Keefer 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Laurie Keefer, PhD principal investigator
Northwestern University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Hypnotherapy and Mind Body Therapy in people with Ulcerative Colitis and Inflammatory Bowel Disease, run by Northwestern University at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 11 inclusion and 25 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 2 Apr 2014. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
feasibility (time frame: 52 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00798642, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 2 Apr 2014.