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

J

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)

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

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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