NCT01573078

Brief Summary

The purpose of this study is to determine whether emotional processing and somatic dissociation influence IBS-like symptoms in Crohn's Disease patients.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
50

participants targeted

Target at P25-P50 for all trials

Timeline
Completed

Started May 2012

Typical duration for all trials

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

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

April 3, 2012

Completed
3 days until next milestone

First Posted

Study publicly available on registry

April 6, 2012

Completed
25 days until next milestone

Study Start

First participant enrolled

May 1, 2012

Completed
2.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 28, 2015

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

January 28, 2015

Completed
Last Updated

May 30, 2018

Status Verified

May 1, 2018

Enrollment Period

2.7 years

First QC Date

April 3, 2012

Last Update Submit

May 25, 2018

Conditions

Crohn's Disease

Keywords

Crohn's diseaseIBSDissociationEmotional processing

Outcome Measures

Primary Outcomes (1)

  • presence of functional gastrointestinal disorder

    within previous 6 months

Secondary Outcomes (3)

  • difference in ability to process emotions

    within previous 6 months

  • difference in body awareness and degree of bodily-dissociation

    within previous 6 months

  • difference in sensitivity to internal bodily sensations

    within previous 6 months

Study Arms (1)

Crohn's disease patient

Outpatients who carry a diagnosis of Crohn's disease made by a gastroenterologist.

Behavioral: Questionnaire

Interventions

QuestionnaireBEHAVIORAL

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)

Crohn's disease patient

Eligibility Criteria

Age19 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Crohn's Disease Patients

You may qualify if:

  • Age of 19 or greater
  • Outpatient with diagnosis of Crohn's disease

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Pacific Gastroenterology Associates

Vancouver, British Columbia, V6Z2K5, Canada

Location

MeSH Terms

Conditions

Crohn DiseaseDissociative Disorders

Interventions

Surveys and Questionnaires

Condition Hierarchy (Ancestors)

Inflammatory Bowel DiseasesGastroenteritisGastrointestinal DiseasesDigestive System DiseasesIntestinal DiseasesMental Disorders

Intervention Hierarchy (Ancestors)

Data CollectionEpidemiologic MethodsInvestigative TechniquesHealth Care Evaluation MechanismsQuality of Health CareHealth Care Quality, Access, and EvaluationPublic HealthEnvironment and Public Health

Study Officials

  • Robert Enns, MD

    University of British Columbia

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
OTHER
Time Perspective
CROSS SECTIONAL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Dr. Robert Enns

Study Record Dates

First Submitted

April 3, 2012

First Posted

April 6, 2012

Study Start

May 1, 2012

Primary Completion

January 28, 2015

Study Completion

January 28, 2015

Last Updated

May 30, 2018

Record last verified: 2018-05

Locations

CA(1)