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

Primary Purpose

Crohn's Disease

Status
Unknown status
Phase
Not Applicable
Locations
China
Study Type
Interventional
Intervention
Personality Traits Questionnaires
Sponsored by
Jinling Hospital, China
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional diagnostic trial for Crohn's Disease focused on measuring Crohn's disease, inflammatory bowel disease, quality of life, personality, neuroticism

Eligibility Criteria

18 Years - 65 Years (Adult, Older Adult)All SexesDoes not accept 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

Sites / Locations

  • Department of Surgery, Jinling Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Active CD

Quiescent CD

Arm Description

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

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

Outcomes

Primary Outcome Measures

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).

Secondary Outcome Measures

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).
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.
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.

Full Information

First Posted
June 19, 2013
Last Updated
June 24, 2013
Sponsor
Jinling Hospital, China
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1. Study Identification

Unique Protocol Identification Number
NCT01887548
Brief Title
Personality Traits and Its Impact on Quality of Life and Clinical Outcome Evaluation in Crohn's Patients
Official Title
Personality Traits and Its Impact on Quality of Life and Clinical Outcome Evaluation in Patients With Crohn's Disease
Study Type
Interventional

2. Study Status

Record Verification Date
June 2013
Overall Recruitment Status
Unknown status
Study Start Date
March 2012 (undefined)
Primary Completion Date
December 2013 (Anticipated)
Study Completion Date
December 2013 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Jinling Hospital, China

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Crohn's Disease
Keywords
Crohn's disease, inflammatory bowel disease, quality of life, personality, neuroticism

7. Study Design

Primary Purpose
Diagnostic
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
80 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Active CD
Arm Type
Experimental
Arm Description
Patients whose CDAI score >150 points would be enrolled in this group.
Arm Title
Quiescent CD
Arm Type
Active Comparator
Arm Description
Patients whose CDAI score ≤150 points would be enrolled in this group.
Intervention Type
Other
Intervention Name(s)
Personality Traits Questionnaires
Intervention Description
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.
Primary Outcome Measure Information:
Title
IBDQ
Description
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).
Time Frame
one week
Secondary Outcome Measure Information:
Title
Eysenck Personality Inventory (EPI)
Description
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).
Time Frame
one week
Title
Hospital Anxiety and Depression Scale (HADS)
Description
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.
Time Frame
one week
Title
Buss Perry Aggregation (BPA) questionnaire
Description
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.
Time Frame
one week

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Facility Information:
Facility Name
Department of Surgery, Jinling Hospital
City
Nanjing
State/Province
Jiangsu
ZIP/Postal Code
210002
Country
China

12. IPD Sharing Statement

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

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