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Psychological Status and Related Factors of Thyroid Related Eye Disease

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ClinicalTrials.gov Identifier: NCT03426696
Recruitment Status : Recruiting
First Posted : February 8, 2018
Last Update Posted : February 8, 2018
Sponsor:
Information provided by (Responsible Party):
Huijing Ye, Sun Yat-sen University

Brief Summary:
The purpose of this study is to evaluate the psychological status of Thyroid Related Eye Disease.

Condition or disease Intervention/treatment
Thyroid Related Eye Disease Behavioral: psychological condition

Detailed Description:
The purpose of this study is to evaluate the psychological status of patients of Thyroid Related Eye Disease over 16 years old, and to analyze the related factors of them.

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Study Type : Observational
Estimated Enrollment : 300 participants
Observational Model: Case-Only
Time Perspective: Prospective
Official Title: Psychological Status and Related Factors of Thyroid Related Eye Disease
Actual Study Start Date : December 1, 2017
Estimated Primary Completion Date : December 1, 2018
Estimated Study Completion Date : December 1, 2018

Resource links provided by the National Library of Medicine

Drug Information available for: Thyroid

Group/Cohort Intervention/treatment
Thyroid Related Eye Disease
Survey about the psychological condition would done with the patients of Thyroid Related Eye Disease
Behavioral: psychological condition
Graves ́ ophthalmopathy quality of life questionnaire, Symptom checklist 90(SLC-90), Hamilton anxiety scale(HAMA), Somatic self-rating scale(SSS), MATRICS Consensus Cognitive Battery (MCCB), Hamilton depression scale(HAMD)




Primary Outcome Measures :
  1. Quality of life questionnaire of patients of Thyroid Related Eye Disease [ Time Frame: immediately ]
    Graves ́ ophthalmopathy quality of life questionnaire (GO-QoL) , The GO-QoL contains 8 questions on visual functioning and 8 questions on appearance; answers on each subscale are transformed to scores ranging from 0 (worst) to 100 (best).


Secondary Outcome Measures :
  1. Symptom checklist 90(SLC-90) [ Time Frame: immediately ]
    It consists of 90 items yielding nine scores along primary symptom dimensions and three scores among global distress indices. The primary symptom dimensions that are assessed are somatization, obsessive-compulsive, interpersonal sensitivity, depression, anxiety, hostility, phobic anxiety, paranoid ideation, psychoticism, and a category of "additional items" which helps clinicians assess other aspect of the clients symptoms. Positive standard includes: total score 160 points or more, or positive items > 43 points, or any item > 2 points.

  2. Hamilton anxiety scale(HAMA) [ Time Frame: immediately ]
    This scale includes 14 items. All projects rated as: asymptomatic, light, medium, heavy, or very heavy. If the total score more than 29 points, there could be severe anxiety; more than 21 points, affirmation have obvious anxiety; more than 14 points, there must be some anxious; more than 7 points might be anxious; if less than 6 points, patients without anxiety symptoms.

  3. Somatic self-rating scale(SSS) [ Time Frame: immediately ]
    Somatic self-rating scale can let the doctor fully understand patients' mood and somatization symptoms. If the selected items scores more than 30 points, the patient may need to clinic treatment.

  4. Hamilton depression scale(HAMD) [ Time Frame: immediately ]
    It is the most common depression clinical application scale. Lower score presents lighter condition, and if the illness is heavier, the higher is the score. There is no depression symptoms for score less than eight points.

  5. Young manic rating scale(YMRS) [ Time Frame: immediately ]
    The Young Mania Rating Scale (YMRS) is a diagnostic questionnaire commonly used to evaluate manic symptoms in patients with bipolar 1 disorder and to assess treatment efficacy in clinical trials. This rating scale comprises eleven items (elevated mood, increased motor activity - energy, sexual interest, sleep, irritability, speech - rate and amount, language-thought disorder, content, disruptive-aggressive behavior, appearance, and insight). The total YMRS score is calculated as the summation of each of the eleven individual item scores.Lower score presents lighter condition, and if the illness is heavier, the higher is the score.There is no manic symptoms for score less than five points.



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Ages Eligible for Study:   16 Years and older   (Child, Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population
patients in Sun Yat-sen University that diagnosed as Thyroid Related Eye Disease
Criteria

Inclusion Criteria:

  • over 16 years old
  • diagnosed as Thyroid Related Eye Disease

Exclusion Criteria:

  • any uncontrolled clinical problems

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03426696


Contacts
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Contact: Huijing Ye, Master +00862087331539 yehuijing@qq.com
Contact: Huasheng Yang, Doctor +00862087331539 yanghs64@126.com

Locations
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China, Guangdong
Sun Yat-sen University Recruiting
Guangzhou, Guangdong, China, 510000
Contact: Huijing Ye, Master    00862087331539    yehuijing@qq.com   
Contact: Huasheng Yang, Doctor    00862087331539    yanghs64@126.com   
Sponsors and Collaborators
Huijing Ye
Investigators
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Principal Investigator: Huijing Ye, Master Sun Yat-sen University

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Responsible Party: Huijing Ye, Principal Investigator, Sun Yat-sen University
ClinicalTrials.gov Identifier: NCT03426696     History of Changes
Other Study ID Numbers: 201701
First Posted: February 8, 2018    Key Record Dates
Last Update Posted: February 8, 2018
Last Verified: February 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Huijing Ye, Sun Yat-sen University:
psychological status
Related Factors
Thyroid Related Eye Disease
Additional relevant MeSH terms:
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Thyroid Diseases
Eye Diseases
Endocrine System Diseases