Psychological Status and Related Factors of Thyroid Related Eye Disease

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

Study Overview

• Status: Completed
• Conditions: Thyroid Related Eye Disease
• Intervention / Treatment: 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.

• Study Type: Observational
• Enrollment (Actual): 300

Contacts and Locations

Study Locations

• China
  • Guangdong
    • Guangzhou, Guangdong, China, 510000
      • Sun Yat-sen University

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 16 years and older (Child, Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Probability Sample

Study Population

patients in Sun Yat-sen University that diagnosed as Thyroid Related Eye Disease

Description

Inclusion Criteria:

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

Exclusion Criteria:

• any uncontrolled clinical problems

Study Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

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)

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Quality of life questionnaire of patients of Thyroid Related Eye Disease	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).	immediately

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Symptom checklist 90(SLC-90)	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.	immediately
Hamilton anxiety scale(HAMA)	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.	immediately
Somatic self-rating scale(SSS)	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.	immediately
Hamilton depression scale(HAMD)	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.	immediately
Young manic rating scale(YMRS)	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.	immediately

Collaborators and Investigators

• Sponsor: Huijing Ye
• Investigators: Principal Investigator: Huijing Ye, Master, Sun Yat-sen University

Study record dates

Study Major Dates

• Study Start (Actual): December 1, 2017
• Primary Completion (Actual): December 1, 2018
• Study Completion (Actual): December 31, 2018

Study Registration Dates

• First Submitted: February 1, 2018
• First Submitted That Met QC Criteria: February 7, 2018
• First Posted (Actual): February 8, 2018

Study Record Updates

• Last Update Posted (Actual): May 21, 2020
• Last Update Submitted That Met QC Criteria: May 21, 2020
• Last Verified: May 1, 2020

More Information

Terms related to this study

• Keywords: psychological status; Related Factors; Thyroid Related Eye Disease
• Additional Relevant MeSH Terms: Endocrine System Diseases; Eye Diseases; Thyroid Diseases
• Other Study ID Numbers: 201701

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No