Overview

This trial is active, not recruiting.

Condition crohn's disease
Treatment personality traits questionnaires
Sponsor Jinling Hospital, China
Start date March 2012
End date December 2013
Trial size 80 participants
Trial identifier NCT01887548, 20130618

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.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Allocation non-randomized
Intervention model parallel assignment
Masking open label
Primary purpose diagnostic
Arm
(Experimental)
Patients whose CDAI score >150 points would be enrolled in this group.
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.
(Active Comparator)
Patients whose CDAI score ≤150 points would be enrolled in this group.
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.

Primary Outcomes

Measure
IBDQ
time frame: one week

Secondary Outcomes

Measure
Eysenck Personality Inventory (EPI)
time frame: one week
Hospital Anxiety and Depression Scale (HADS)
time frame: one week
Buss Perry Aggregation (BPA) questionnaire
time frame: one week

Eligibility Criteria

Male or female participants from 18 years up to 65 years old.

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

Additional Information

Official title Personality Traits and Its Impact on Quality of Life and Clinical Outcome Evaluation in Patients With Crohn's Disease
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.
Trial information was received from ClinicalTrials.gov and was last updated in June 2013.
Information provided to ClinicalTrials.gov by Jinling Hospital, China.