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

NCT01887548 | Unknown DMC

• 1 other identifier: 20130618
• Study Type: interventional
• Target: 80
• Locations: 1 country
• Sites: 1

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.

Conditions

Crohn's Disease

Keywords

Crohn's disease; inflammatory bowel disease; quality of life; personality; neuroticism

Outcome Measures

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).

  one week

Secondary Outcomes (3)

• Eysenck Personality Inventory (EPI)

  one week

• Hospital Anxiety and Depression Scale (HADS)

  one week

• Buss Perry Aggregation (BPA) questionnaire

  one week

Study Arms (2)

Active CD

EXPERIMENTAL

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

Other: Personality Traits Questionnaires

Quiescent CD

ACTIVE COMPARATOR

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

Other: Personality Traits Questionnaires

Interventions

Personality Traits Questionnaires OTHER

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 CD; Quiescent CD

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• years old
• a definite diagnosis of CD

You may not qualify if:

• 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

Sponsors & Collaborators

• Jinling Hospital, China: lead

Study Sites (1)

Department of Surgery, Jinling Hospital

Nanjing, Jiangsu, 210002, China

Location

MeSH Terms

Conditions

Crohn Disease; Inflammatory Bowel Diseases

Condition Hierarchy (Ancestors)

Gastroenteritis; Gastrointestinal Diseases; Digestive System Diseases; Intestinal Diseases

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Vice president of department of surgery, Jinling Hospital

Study Record Dates

• First Submitted: June 19, 2013
• First Posted: June 27, 2013
• Study Start: March 1, 2012
• Primary Completion: December 1, 2013
• Study Completion: December 1, 2013
• Last Updated: June 27, 2013

Record last verified: 2013-06

Locations

CN (1)