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

NCT ID: NCT01887548

Last Updated: 2013-06-27

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

80 participants

Study Classification

INTERVENTIONAL

Study Start Date

2012-03-31

Study Completion Date

2013-12-31

Brief Summary

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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

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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.

Conditions

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Crohn's Disease

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

DIAGNOSTIC

Blinding Strategy

NONE

Study Groups

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Active CD

Patients whose CDAI score \>150 points would be enrolled in this group.

Group Type EXPERIMENTAL

Personality Traits Questionnaires

Intervention Type OTHER

Patients are required to fill out several personality traits questionnaires. The following personality traits scores would be collected: IBDQ, IBDQ-Emotional function score, IBDQ-Social function score, IBDQ-Bowel function score, IBDQ-Systemic symptom score, Neuroticism score, Lie (social conformity/desirability) score, Hospital anxiety score, Hospital depression score, Buss-Perry score, PA (physical aggression) score, VA (verbal aggression) score, A (anger) score, H (hostility) score.

Quiescent CD

Patients whose CDAI score ≤150 points would be enrolled in this group.

Group Type ACTIVE_COMPARATOR

Personality Traits Questionnaires

Intervention Type OTHER

Patients are required to fill out several personality traits questionnaires. The following personality traits scores would be collected: IBDQ, IBDQ-Emotional function score, IBDQ-Social function score, IBDQ-Bowel function score, IBDQ-Systemic symptom score, Neuroticism score, Lie (social conformity/desirability) score, Hospital anxiety score, Hospital depression score, Buss-Perry score, PA (physical aggression) score, VA (verbal aggression) score, A (anger) score, H (hostility) score.

Interventions

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Personality Traits Questionnaires

Patients are required to fill out several personality traits questionnaires. The following personality traits scores would be collected: IBDQ, IBDQ-Emotional function score, IBDQ-Social function score, IBDQ-Bowel function score, IBDQ-Systemic symptom score, Neuroticism score, Lie (social conformity/desirability) score, Hospital anxiety score, Hospital depression score, Buss-Perry score, PA (physical aggression) score, VA (verbal aggression) score, A (anger) score, H (hostility) score.

Intervention Type OTHER

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Maximum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Jinling Hospital, China

OTHER

Sponsor Role lead

Responsible Party

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Jianan Ren

Vice president of department of surgery, Jinling Hospital

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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Department of Surgery, Jinling Hospital

Nanjing, Jiangsu, China

Site Status

Countries

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China

Other Identifiers

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20130618

Identifier Type: -

Identifier Source: org_study_id

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