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Clinical Trials/NCT01887548
NCT01887548
Unknown
N/A

Personality Traits and Its Impact on Quality of Life and Clinical Outcome Evaluation in Patients With Crohn's Disease

Jinling Hospital, China1 site in 1 country80 target enrollmentMarch 2012
ConditionsCrohn's Disease

Overview

Phase
N/A
Intervention
Not specified
Conditions
Crohn's Disease
Sponsor
Jinling Hospital, China
Enrollment
80
Locations
1
Primary Endpoint
IBDQ
Last Updated
12 years ago

Overview

Brief Summary

Quality of life is recommended as one of essential parameters to evaluate treatment effect and clinical outcome in patients with Crohn's disease (CD). Recent studies reported that several disease-unrelated variables may affect quality of life in CD patients. This study is dedicated to investigate the influence of various personality traits on quality of life, and whether or not they should be taken into account when evaluating clinical outcomes in patients with CD.

Detailed Description

This is a prospective, single-center study. All enrolled patients are divided into 2 groups: * Group 1: quiescent CD group (CDAI≤150 points) * Group 2: active CD group (CDAI\>150 points) All enrolled patients are required to accomplish the following questionnaires at visit: * Inflammatory Bowel Disease Questionnaire (IBDQ) * Neuroticism (N) and Lie (L) subscale of the Eysenck Personality Inventory (EPI) * Hospital Anxiety and Depression Scale (HADS) * Buss-Perry Aggression (BPA) questionnaire All questionnaires are translated and validated in Chinese population.

Registry
clinicaltrials.gov
Start Date
March 2012
End Date
December 2013
Last Updated
12 years ago
Study Type
Interventional
Study Design
Parallel
Sex
All

Investigators

Sponsor
Jinling Hospital, China
Responsible Party
Principal Investigator
Principal Investigator

Jianan Ren

Vice president of department of surgery, Jinling Hospital

Jinling Hospital, China

Eligibility Criteria

Inclusion Criteria

  • 18-65 years old
  • a definite diagnosis of CD

Exclusion Criteria

  • current or previous mental disorders
  • receiving or once received psychotherapy
  • presence of major medical conditions (such as necessity of an operation)
  • chronic disease history other than inflammatory bowel disease
  • unwilling to participate in or cannot accomplish current study

Outcomes

Primary Outcomes

IBDQ

Time Frame: one week

Inflammatory Bowel Disease Questionnaires (IBDQ) is the most widely used and validated disease-specific instrument, which contains 32 items and assesses four aspects (subscales) of quality of life: emotional function (12 items), social function (5 items), bowel function (10 items) and systemic symptom (5 items).

Secondary Outcomes

  • Eysenck Personality Inventory (EPI)(one week)
  • Hospital Anxiety and Depression Scale (HADS)(one week)
  • Buss Perry Aggregation (BPA) questionnaire(one week)

Study Sites (1)

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