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

Jinling Hospital, China

Status: Unknown

Conditions: Crohn's Disease

Treatments: Other: Personality Traits Questionnaires

Study type: Interventional

Funder types: Other

Identifiers

NCT01887548

20130618

Details and patient eligibility

About

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.

Full 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.

Enrollment: 80 patients

Sex: All

Ages: 18 to 65 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Diagnostic

Allocation: Non-Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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80 participants in 2 patient groups

Active CD

Experimental group

Description:

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

Treatment:

Other: Personality Traits Questionnaires

Quiescent CD

Active Comparator group

Description:

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

Treatment:

Other: Personality Traits Questionnaires