Crohn's DiseaseNCT01887548
Personality Traits and Its Impact on Quality of Life and Clinical Outcome Evaluation in Crohn's Patients
A study testing Personality Traits Questionnaires in people with Crohn's Disease, run by Jinling Hospital, China at 1 site in China.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Crohn's Disease
- What is being tested?
- Personality Traits Questionnaires
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 80 participants
- Where
- 1 siteChina
- Study dates
- Mar 2012to Dec 2013
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 18-65 years old
- a definite diagnosis of CD
Who cannot join
- 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 locations and contacts
1 site in 1 country.
About this study
Official title: 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.
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.
- Conditions
- Crohn's Disease
- Being tested
- Personality Traits Questionnaires
- Keywords
- Crohn's disease, inflammatory bowel disease, quality of life, personality, neuroticism
- Medical subject headings
- Crohn Disease, Inflammatory Bowel Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Personality Traits QuestionnairesOther
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.
| Study group | Role | What they receive |
|---|---|---|
| Active CD | Experimental | Patients whose CDAI score >150 points would be enrolled in this group. Receives: Other: Personality Traits Questionnaires |
| Quiescent CD | Active comparator | Patients whose CDAI score ≤150 points would be enrolled in this group. Receives: Other: Personality Traits Questionnaires |
What is being measured
The primary outcome is the main question the study is designed to answer.
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).
Measured: one week
Secondary outcomes (3)
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).
Measured: one week
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.
Measured: one week
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.
Measured: one week
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Jun 2013 (estimated)
- Study startMar 2012
- Primary completionDec 2013 (estimated)
- Study completionDec 2013 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Crohn's DiseaseStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Diagnosis
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 80 participants (actual)
Sponsor and investigators
- Lead sponsor
- Jinling Hospital, China
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Jianan Ren, Jinling Hospital, China
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01887548
- Sponsor's protocol ID
- 20130618
- Status last verified
- Jun 2013
- First submitted
- 19 Jun 2013
- Last updated
- 27 Jun 2013
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 27 Jun 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Personality Traits and Its Impact on Quality of Life and Clinical Outcome Evaluation in Patients With Crohn's Disease
- ClinicalTrials.gov ID
- NCT01887548
- Acronym / sponsor ID
- 20130618
- Conditions
- Crohn's Disease
- Keywords
- Crohn's disease, inflammatory bowel disease, quality of life, personality, neuroticism
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 80 participants (actual)
- Lead sponsor
- Jinling Hospital, ChinaUniversity, hospital or other
- Study start
- Mar 2012
- Primary completion
- Dec 2013 (estimated)
- Study completion
- Dec 2013 (estimated)
- First posted
- 27 Jun 2013 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Primary purpose
- Diagnosis
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Active CD | Experimental | Other: Personality Traits QuestionnairesPatients whose CDAI score >150 points would be enrolled in this group. |
| Quiescent CD | Active comparator | Other: Personality Traits QuestionnairesPatients whose CDAI score ≤150 points would be enrolled in this group. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- 18-65 years old
- a definite diagnosis of CD
Key exclusion criteria (5 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Personality Traits QuestionnairesPatients 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. | Other | Active CD, Quiescent CD |
Primary outcome
IBDQ
Time frame: one week
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).
3 secondary outcomes
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
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Jun 2013.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Personality Traits Questionnaires in people with Crohn's Disease, run by Jinling Hospital, China at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 27 Jun 2013. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
IBDQ (time frame: one week). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 27 Jun 2013.