CClinicalTrials.gg
Status unknownNCT01887548Updated Jun 27, 2013

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

An interventional study of Personality Traits Questionnaires in Crohn's Disease, sponsored by Jinling Hospital, China. Status unknown at 1 site in China. Open to participants aged 18 Years to 65 Years. Per ClinicalTrials.gov, last updated 2013-06-27.

Sponsored by Jinling Hospital, China · Not applicable, Interventional, and Diagnostic

The sponsor has not verified this record recently (last verified Jun 2013), so the status shown — last known as Active, not recruiting — may be out of date.
Phase
Not applicable
Study type
Interventional
Enrollment
80
Allocation
Non-randomized
Ages
18 Years to 65 Years
Sex
All
01

Study 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.

Read the 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.

02

Conditions studied

  • Crohn's Disease

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Keywords

  • Crohn's disease
  • inflammatory bowel disease
  • quality of life
  • personality
  • neuroticism
03

In context

Crohn Disease

1,880 studies on the registry are indexed under Crohn Disease; 462 are open to participants now.

This study's enrollment of 80 is above the median of 66 across 1,188 interventional studies indexed under Crohn Disease.

Browse Crohn Disease studies →

Lead sponsor

Jinling Hospital, China is the lead sponsor of 126 studies on the registry; 34 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 65 Years
Sexes eligible
All
Accepts healthy volunteers
No

Inclusion criteria

  • 18-65 years old
  • a definite diagnosis of CD

Exclusion criteria

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
05

Study design

Phase
Not applicable
Primary purpose
Diagnostic
Allocation
Non-randomized
Intervention model
Parallel assignment
Masking
None (open label)
Enrollment
80 participants (actual)

Study arms

  • Experimental
    Active CD

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

    Other: Personality Traits Questionnaires

  • Active comparator
    Quiescent CD

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

    Other: Personality Traits Questionnaires

Interventions

  • OtherPersonality 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.

06

What researchers measure

Primary outcomes

  1. 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).

    Time frame: one week

Secondary outcomes

  1. 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).

    Time frame: one week

  2. 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.

    Time frame: one week

  3. 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.

    Time frame: one week

07

Study locations

1 site
  • Department of Surgery, Jinling Hospital
    Nanjing, Jiangsu 210002, China
08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Jun 27, 2013, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT01887548
Lead sponsor
Jinling Hospital, China
Responsible party
Jianan Ren (Vice president of department of surgery, Jinling Hospital, Jinling Hospital, China) — Principal investigator
First posted
Jun 27, 2013
Start date
Mar 2012
Primary completion
Dec 2013 (estimated)
Completion
Dec 2013 (estimated)
Last update
Jun 27, 2013

Oversight

Data monitoring committee
Yes
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is status unknown, as verified in Jun 2013. You cannot join it, but the record below documents what was studied.

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