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

Study Overview
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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.

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

Conditions
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Crohn's Disease

Intervention / Treatment
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* Other: Personality Traits Questionnaires


Participation Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 65 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Diagnostic
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Active CD<br>Patients whose CDAI score >150 points would be enrolled in this group. | Other: Personality Traits Questionnaires<br>* 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.<br>|
| Active Comparator: Quiescent CD<br>Patients whose CDAI score ≤150 points would be enrolled in this group. | Other: Personality Traits Questionnaires<br>* 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.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| IBDQ | 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). | one week | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Eysenck Personality Inventory (EPI) | To assess neuroticism and social conformity and desirability, the Neuroticism and Lie subscales from the Eysenck Personality Inventory (EPI) were adopt in current study. Twenty-three items are designed to evaluate neuroticism (Neuroticism subscale) and the other 21 items are assigned for social desirability (Lie subscale). | one week | 
| Hospital Anxiety and Depression Scale (HADS) | The Hospital Anxiety and Depression Scale (HADS) was first developed in 1983 and has been extensively used in subsequent studies to identify the potential anxiety and depression in nonpsychiatric hospitalized patients. This questionnaire includes separated Anxiety and Depression subscales with seven items, respectively. | one week | 
| Buss Perry Aggregation (BPA) questionnaire | BPA is one of the most popular self-report inventories for the measurement of four different dimensions (anger, hostility, physical aggression and verbal aggression). This 29-item questionnaire is scored with a 5-level scale for each question, contributing to a total score and four subscales of each dimension. A higher score suggests a higher level of aggression feelings. | one week | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Crohn's disease, inflammatory bowel disease, quality of life, personality, neuroticism