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Completed

NCT Number: NCT03426696

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.

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Key information

Age range

16 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Sun Yat-sen University

Guangzhou, Guangdong, 510000, China

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

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

Exclusion criteria

  • any uncontrolled clinical problems

Treatment and study plan

psychological condition

Behavioral

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 outcomes

  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 outcomes

  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.

Sponsors and collaborators

Lead sponsor

Huijing Ye

Other

Registry information

Important dates

Study start
2017
Primary completion
2018
Study completion
2018
First posted
Feb 8, 2018
Registry last updated
May 21, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.