Crohn's DiseaseNCT01573078
Psychology of Crohn's Disease
An observational study of Crohn's Disease, run by University of British Columbia at 1 site in Canada.
Trial summary
The purpose of this study is to determine whether emotional processing and somatic dissociation influence IBS-like symptoms in Crohn's Disease patients. Read more about this study
- Who is it for?
- Ages 19 years and older
- Conditions the study is for
- Crohn's Disease
- What is being tested?
- Questionnaire
- Type of treatment
- Lifestyle or therapy programme
- How many people
- 50 participants
- Where
- 1 siteCanada
- Study dates
- May 2012to 28 Jan 2015
- Phase
- Observational
- 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 19 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Crohn's Disease Patients
Who may be able to join
- Age of 19 or greater
- Outpatient with diagnosis of Crohn's disease
Who cannot join
None listed.
Trial locations and contacts
1 site in 1 country.
Canada1 site
Pacific Gastroenterology Associates
Vancouver, British Columbia, V6Z2K5
About this study
Official title: Will The Real Psychology Of Crohn's Disease Please Stand Up?
The purpose of this study is to determine whether emotional processing and somatic dissociation influence IBS-like symptoms in Crohn's Disease patients.
- Conditions
- Crohn's Disease
- Being tested
- Questionnaire
- Keywords
- Crohn's disease, IBS, Dissociation, Emotional processing
- Medical subject headings
- Crohn Disease, Dissociative Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
QuestionnaireBehavioural
Questionnaire consisting of the following validated surveys: Rome II criteria - Scale of Body Connection (SBC), Private Body Consciousness Sub-Scale (PBCS), Body Vigilance Scale (BVS), Emotional Processing Scale (EPS25)
| Study group | Role | What they receive |
|---|---|---|
| Crohn's disease patient | Outpatients who carry a diagnosis of Crohn's disease made by a gastroenterologist. Receives: Behavioral: Questionnaire |
What is being measured
The primary outcome is the main question the study is designed to answer.
presence of functional gastrointestinal disorder
Measured: within previous 6 months
Secondary outcomes (3)
difference in ability to process emotions
Measured: within previous 6 months
difference in body awareness and degree of bodily-dissociation
Measured: within previous 6 months
difference in sensitivity to internal bodily sensations
Measured: within previous 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Apr 2012 (estimated)
- Study startMay 2012
- Primary completion28 Jan 2015
- Study completion28 Jan 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Crohn's DiseaseStudies of the same condition, open and under way.
- More trials run by University of British ColumbiaThe 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
- Observational
- Observational model
- Other
- Time perspective
- Cross-sectional
- Enrolment
- 50 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of British Columbia
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Robert Enns, University of British Columbia
- Investigators
- Robert Enns, MD, Principal investigator, University of British Columbia
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01573078
- Sponsor's protocol ID
- H11-02479
- Status last verified
- May 2018
- First submitted
- 3 Apr 2012
- Last updated
- 30 May 2018
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 30 May 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Will The Real Psychology Of Crohn's Disease Please Stand Up?
- ClinicalTrials.gov ID
- NCT01573078
- Acronym / sponsor ID
- H11-02479
- Conditions
- Crohn's Disease
- Keywords
- Crohn's disease, IBS, Dissociation, Emotional processing
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 50 participants (actual)
- Lead sponsor
- University of British ColumbiaUniversity, hospital or other
- Study start
- May 2012
- Primary completion
- 28 Jan 2015 (actual)
- Study completion
- 28 Jan 2015 (actual)
- First posted
- 6 Apr 2012 (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 purpose of this study is to determine whether emotional processing and somatic dissociation influence IBS-like symptoms in Crohn's Disease patients.
Study design
- Observational model
- Other
- Time perspective
- Cross-sectional
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Crohn's disease patient | – | Behavioral: QuestionnaireOutpatients who carry a diagnosis of Crohn's disease made by a gastroenterologist. |
Who may qualify
- Ages
- 19 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Crohn's Disease Patients
Key inclusion criteria (2 listed)
- Age of 19 or greater
- Outpatient with diagnosis of Crohn's disease
Key exclusion criteria (0 listed)
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 |
|---|---|---|
| QuestionnaireQuestionnaire consisting of the following validated surveys: Rome II criteria - Scale of Body Connection (SBC), Private Body Consciousness Sub-Scale (PBCS), Body Vigilance Scale (BVS), Emotional Processing Scale (EPS25) | Behavioural | Crohn's disease patient |
Primary outcome
presence of functional gastrointestinal disorder
Time frame: within previous 6 months
3 secondary outcomes
difference in ability to process emotions
Time frame: within previous 6 months
difference in body awareness and degree of bodily-dissociation
Time frame: within previous 6 months
difference in sensitivity to internal bodily sensations
Time frame: within previous 6 months
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 30 May 2018.
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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.
Robert Enns, MD principal investigator
University of British Columbia
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Crohn's Disease, run by University of British Columbia at 1 site in Canada.
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 2 inclusion and 0 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 30 May 2018. 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 Canada. 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. 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?
presence of functional gastrointestinal disorder (time frame: within previous 6 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 30 May 2018.