Thyroid Disease and Personality Study (TPS)

December 1, 2015 updated by: National Taiwan University Hospital

Bio-psycho-social Correlates of Psychological Distress in Patients With Graves' Disease in Euthyroid Status

Observe the relationship between thyroid function and personality traits

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

Detailed Description

Thyrotoxicosis was the biochemical and physiological manifestations of excess thyroid hormone. The clinical manifestation was palpitation, heat intolerance, hand tremor, and weight loss. The clinical manifestation also included nervous system, including anxiety, tension, irritability, hyperactivity, fatigue, and insomnia.

Where tensions features include restless, short attention span, and the impulse to want to move around. Some patients will progress to a non-specific psychiatric disorders. According to the study, about 10% of patients will occur very frank psychosis, 3, 31% to 69% of patients with depressive symptoms, 61% to 62% of patients with symptoms of anxiety.

Some studies using reliable evaluation tool to evaluate behavioral changes in patients with thyrotoxicosis, such as Clyde emotional scale, multi-faceted personality assessment table (Multiphasic Personality Inventory (MMPI)), or observation of a response time to visual or audio stimulation. After treatment of thyrotoxicosis, most of these indicators have improved, but some indicators were still abnormal after treatment of thyrotoxicosis, such as MMPI and voice response time.

The physiological causes of the changes of these nervous system is not clear. The symptoms was improved after the use of sympathetic inhibitors, so presumably this may correlated with autonomic nervous system disorders.

Thyroid hormone receptors are widely distributed in the brain may also be one of the cause. But there still some other reasons for the changes of neurological symptoms because neurological symptoms may not be back to normal even after thyroid function returned to normal. Autoimmune dysfunction affect brain function may be the most possible reason. Graves' disease is the most common cause of thyrotoxicosis and it is related to autoimmune thyroid antibodies.

Clinically, some patients of Graves' disease may combined with other autoimmune disease, such as Sicca syndrome. The patient may still have nervous personality traits despite normalized thyroid function. Some patients even need long-term use of anti-anxiety medication.

In this study, investigators hope to analyze the personality traits of patients with hyperthyroidism,especially patients of Graves' disease, in Taiwan and to observe the changes during treatment. Investigators also hope to observe the statistical change of other non-thyroid-specific autoimmune index in this thyrotoxicosis patient. After obtaining these results, investigators will evaluate whether to continue to study the hypothesis of affection of brain of thyrotoxic patients by the abnormal autoimmune system.

Study Type

Observational

Enrollment (Anticipated)

500

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

  • Name: Shyang-Rong Shih, Doctor
  • Phone Number: 886-972653337
  • Email: srshih@ntu.edu.tw

Study Locations

  • Taiwan
      • Taipei, Taiwan, 100
        • Recruiting
        • Shyang-Rong Shih
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

20 years to 85 years (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

All patients were aged between 20 and 85 years and fulfilled the criteria for euthyroid GD. GD is defined by a history of hyperthyroidism, thyroid eye disease or pretibial myxedema with abnormal high thyroglobulin binding immunoglobulin (TBII) level and autoimmune characteristics on thyroid echography. Euthyroidism is defined by normal free thyroxine (fT4) and thyrotropin (TSH) level.

Description

Inclusion Criteria:

  • aged between 20 and 85 years
  • euthyroid Graves' disease

Exclusion Criteria:

  • Patients who were not capable to complete the questionnaire due to severe cognitive dysfunction or under education were excluded from this study

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
Graves' disease
Patient had been diagnosed of Graves' disease and now under euthyroid status
Procedure: blood sampling
blood sampling

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Psychological distress in scores measured using the Brief Symptom Rating Scale
Time Frame: Within one year after inclusion
Psychological distress is measured by using the Brief Symptom Rating Scale (BSRS). The BSRS is a self-report questionnaire with 30 items rated from 0 to 4 scores on the basis of the degree of distress. BSRS covers nine dimensions of psychopathology: somatization, obsessive-compulsive disorder, interpersonal sensitivity, depression, anxiety, hostility, phobic-anxiety, paranoid ideation, and additional symptoms.
Within one year after inclusion

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

National Taiwan University Hospital

Investigators

  • Study Director: Shyang-Rong Shih, Doctor, National Taiwan University Hospital

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

July 1, 2011

Primary Completion (ANTICIPATED)

July 1, 2021

Study Completion (ANTICIPATED)

July 1, 2021

Study Registration Dates

First Submitted

November 4, 2015

First Submitted That Met QC Criteria

December 1, 2015

First Posted (ESTIMATE)

December 2, 2015

Study Record Updates

Last Update Posted (ESTIMATE)

December 2, 2015

Last Update Submitted That Met QC Criteria

December 1, 2015

Last Verified

November 1, 2015

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 201107013RC

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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