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

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

Status
UNKNOWN
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT01887548
Enrollment
80
Registered
2013-06-27
Start date
2012-03-31
Completion date
2013-12-31
Last updated
2013-06-27

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Crohn's Disease

Keywords

Crohn's disease, inflammatory bowel disease, quality of life, personality, neuroticism

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.

Interventions

OTHERPersonality 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.

Sponsors

Jinling Hospital, China
Lead SponsorOTHER

Study design

Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
DIAGNOSTIC
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
18 Years to 65 Years
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frameDescription
IBDQone weekInflammatory 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

MeasureTime frameDescription
Eysenck Personality Inventory (EPI)one weekTo 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 weekThe 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) questionnaireone weekBPA 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.

Countries

China

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026