Personality Traits and Its Impact on Quality of Life and Clinical Outcome Evaluation in Crohn's Patients
- Conditions
- Crohn's Disease
- Interventions
- Other: Personality Traits Questionnaires
- Registration Number
- NCT01887548
- Lead Sponsor
- Jinling Hospital, China
- 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.
Recruitment & Eligibility
- Status
- UNKNOWN
- Sex
- All
- Target Recruitment
- 80
- 18-65 years old
- a definite diagnosis of CD
- 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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Active CD Personality Traits Questionnaires Patients whose CDAI score \>150 points would be enrolled in this group. Quiescent CD Personality Traits Questionnaires Patients whose CDAI score ≤150 points would be enrolled in this group.
- Primary Outcome Measures
Name Time Method IBDQ 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 Outcome Measures
Name Time Method Eysenck Personality Inventory (EPI) one week 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).
Hospital Anxiety and Depression Scale (HADS) one week 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.
Buss Perry Aggregation (BPA) questionnaire one week 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.
Trial Locations
- Locations (1)
Department of Surgery, Jinling Hospital
🇨🇳Nanjing, Jiangsu, China