- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01887548
Personality Traits and Its Impact on Quality of Life and Clinical Outcome Evaluation in Crohn's Patients
June 24, 2013 updated by: Jianan Ren, Jinling Hospital, China
Personality Traits and Its Impact on Quality of Life and Clinical Outcome Evaluation in Patients With Crohn's Disease
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.
Study Overview
Status
Unknown
Conditions
Intervention / Treatment
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.
Study Type
Interventional
Enrollment (Actual)
80
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
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Jiangsu
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Nanjing, Jiangsu, China, 210002
- Department of Surgery, Jinling Hospital
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Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years to 65 years (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
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 Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Diagnostic
- Allocation: Non-Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Active CD
Patients whose CDAI score >150 points would be enrolled in this group.
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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.
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Active Comparator: Quiescent CD
Patients whose CDAI score ≤150 points would be enrolled in this group.
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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.
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
IBDQ
Time Frame: one week
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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).
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one week
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Eysenck Personality Inventory (EPI)
Time Frame: 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).
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one week
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Hospital Anxiety and Depression Scale (HADS)
Time Frame: one week
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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.
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one week
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Buss Perry Aggregation (BPA) questionnaire
Time Frame: one week
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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.
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one week
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Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
March 1, 2012
Primary Completion (Anticipated)
December 1, 2013
Study Completion (Anticipated)
December 1, 2013
Study Registration Dates
First Submitted
June 19, 2013
First Submitted That Met QC Criteria
June 24, 2013
First Posted (Estimate)
June 27, 2013
Study Record Updates
Last Update Posted (Estimate)
June 27, 2013
Last Update Submitted That Met QC Criteria
June 24, 2013
Last Verified
June 1, 2013
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 20130618
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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