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

Crohn's Disease Clinical Trial

Official title:

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

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT01887548
• Other study ID #: 20130618
• Status: Active, not recruiting
• Phase: N/A
• First received: June 19, 2013
• Last updated: June 24, 2013
• Start date: March 2012
• Est. completion date: December 2013

Study information

• Verified date: June 2013
• Source: Jinling Hospital, China
• Contact: n/a
• Is FDA regulated: No
• Health authority: China: Food and Drug Administration
• Study type: Interventional

Clinical Trial 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.

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 information / eligibility

• Status: Active, not recruiting
• Enrollment: 80
• Est. completion date: December 2013
• Est. primary completion date: December 2013
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 65 Years

Eligibility

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

Study Design

Allocation: Non-Randomized, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Diagnostic

Related Conditions & MeSH terms

• Crohn Disease
• Crohn's Disease

Intervention

Other:
• 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.

Locations

Country	Name	City	State
China	Department of Surgery, Jinling Hospital	Nanjing	Jiangsu

Sponsors (1)

Lead Sponsor	Collaborator
Jinling Hospital, China

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	No
Secondary	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	No
Secondary	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	No
Secondary	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	No