Psychology of Crohn's Disease | NCT01573078

Studies
Psychology of Crohn's Disease

NCT01573078

Sponsor

University of British Columbia

Status

Completed

Last Update Posted

May 30, 2018Actual

Enrollment

50Actual

Phase

Not provided

Conditions

Crohn's Disease

Interventions

Questionnaire

Countries

Canada

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

May 2018

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

May 2012

Primary Completion Date

Jan 28, 2015Actual

Completion Date

Jan 28, 2015Actual

First Submitted Date

Apr 3, 2012

First Submission Date that Met QC Criteria

Apr 4, 2012

First Posted Date

Apr 6, 2012Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

May 25, 2018

Last Update Posted Date

May 30, 2018Actual

Description Module

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.

Detailed Description

Not provided

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

50Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Crohn's disease patient		Outpatients who carry a diagnosis of Crohn's disease made by a gastroenterologist.	Behavioral: Questionnaire

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Questionnaire	Behavioral	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)

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
presence of functional gastrointestinal disorder		within previous 6 months

Secondary Outcomes

Measure	Description	Time Frame
difference in ability to process emotions		within previous 6 months
difference in body awareness and degree of bodily-dissociation		within previous 6 months

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

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

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

19 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

Crohn's Disease Patients

Sampling Method

Non-Probability Sample

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Robert Enns, MD	University of British Columbia	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Pacific Gastroenterology Associates		Vancouver	British Columbia	V6Z2K5	Canada

Condition Browse Module

MeSH Terms

ID	Term
D003424	Crohn Disease
D004213	Dissociative Disorders

Ancestor Terms

ID	Term
D015212	Inflammatory Bowel Diseases
D005759	Gastroenteritis
D005767	Gastrointestinal Diseases
D004066	Digestive System Diseases

Browse Leaves

Not provided

Browse Branches

Not provided

Intervention Browse Module

MeSH Terms

ID	Term
D011795	Surveys and Questionnaires

Ancestor Terms

ID	Term
D003625	Data Collection
D004812	Epidemiologic Methods
D008919	Investigative Techniques
D017531	Health Care Evaluation Mechanisms

Browse Leaves

Not provided

Browse Branches

Not provided