• Fatigue Severity Scale (FFS). • Hamilton Rating Scale for Depression (HRSD-17). • Hamilton Anxiety Rating Scale (HAM-A). in Hypothyroidism Primary - Clinical Trials Registry

Study Overview

Status

Enrolling by invitation

Conditions

Hypothyroidism Primary

Intervention / Treatment

Behavioral: • Fatigue Severity Scale (FFS). • Hamilton Rating Scale for Depression (HRSD-17). • Hamilton Anxiety Rating Scale (HAM-A).

Detailed Description

Hypothyroidism is a prevalent endocrine illness with a global impact, necessitating treatment in extreme instances. Inadequate management of hypothyroidism has been associated with adverse health outcomes, including neurological and musculoskeletal issues,this condition impacting approximately 1-6% of the general population.

Thyroid hormone is essential for the normal development of many human tissues and regulates the metabolism of virtually all cells and organs of the human body throughout life. Overt hypothyroidism is defined by thyroid-stimulating hormone (TSH) levels above the upper limit of the reference range, while levels of free thyroxine (fT4) are below the lower limit of the reference range. The reference range is typically statistically defined by the 2.5th and 97.5th percentiles of the measured circulating thyroid hormone values in populations defined as healthy.

It has been reported that up to one-third of patients presenting with fatigue have thyroid disease, predominantly in women,and fatigue was the most common noted symptom among patients with hypothyroidism.Also patients with thyroid disorders are more prone to developing depressive symptoms.

There are few previous studies that addressed this topic in the Egyptian population.

Study Type

Observational

Enrollment (Estimated)

406

Contacts and Locations

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

Study Locations

Egypt
- - Assuit, Egypt
    - Assuit university hospitals

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

Adult

Accepts Healthy Volunteers

No

Sampling Method

Non-Probability Sample

Study Population

Patients diagnosed with primary hypothyroidism with age from 18 to 60 years.

Description

Inclusion Criteria:

Patients diagnosed with primary hypothyroidism.
Age from 18 to 60 years.

Exclusion Criteria:

Patients who were previously diagnosed with any psychiatric diseases.
Serious and chronic diseases (e.g. anemia, liver, heart or kidney problems).
consumption of medications that may interfere with thyroid function (e.g., chemotherapy), patients who had a history of any type of cancer, due to the confounding effects of cancer on fatigue as the outcome of interest.
Women who were pregnant or had given birth in the last 6 months to exclude postpartum thyroiditis and depression.

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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Prevalence of chronic fatigue in patients with hypothyroidism at Assuit University Hospitals. Time Frame: Baseline	Prevelance of fatigue will be assessd by fatigue severity scale, this scale consists of nine items, each item consists of statements that are scored on a seven-point Likert type scale ranging from 1 ("strongly disagree") to 7 ("strongly agree"). The minimum score is 9 and the maximum score possible is 63. Higher the score = greater fatigue severity. The scores are averaged across the nine statements, and a score ≥36 indicates a clinically significant trait level of fatigue.	Baseline
Prevalence of depression in patients with hypothyroidism at Assuit University Hospitals. Time Frame: Baseline	Prevalence of depression will be assessed by Hamilton Rating Scale for Depression ,it consists of 17 items, each of them is rated on a 0-4 scale, except for items 10 (sleep disorders) and 14 (somatic symptoms), which are rated on a 0-2 scale. The scores are interpreted as follows : HAM-D score 7-17: mild depression; HAM-D score 18-24: moderate depression; and HAM-D score 25 or higher: severe depression	Baseline
Prevalence of anxiety in patients with hypothyroidism at Assuit University Hospitals. Time Frame: Baseline	Prevalence of anxiety will be assessed by Hamilton Rating Scale of Anxiety, The scale consists of 14 items, each defined by a series of symptoms, and measures both psychic anxiety (mental agitation and psychological distress) and somatic anxiety (physical complaints related to anxiety). Each item is scored on a scale of 0 (not present) to 4 (very severe), with a total score range of 0-56, where <17 indicates mild severity, 18-24 mild to moderate severity and 25-30 moderate to severe.	Baseline

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Compare the severity of chronic fatigue according to the duration and control of treatment in patients with hypothyroidism. Time Frame: Baseline	By using the Fatigue Severity Scale with the minimum score is 9 and the maximum score possible is 63. The higher the score the greater fatigue severity. We will compare the severity of fatigue to the duration of levothyroxine treatment and if there is improvement of fatigue severity in hypothyroidism patients with good control of treatment or not.	Baseline
Compare the severity of depression according to the duration and control of treatment in patients with hypothyroidism. Time Frame: Baseline	By using the Hamilton Depression Rating Scale with the following scores; HAM-D score 7-17: mild depression; HAM-D score 18-24: moderate depression; and HAM-D score 25 or higher: severe depression. We will compare the relationship between the severity of depression and the duration and control of levothyroxine treatment in hypothyroid patients. We will compare if there is improvement of the severity of depression with good control of treatment or not.	Baseline
Compare the severity of anxiety according to the duration and control of treatment in patients with hypothyroidism. Time Frame: Baseline	By using the Hamilton Anxiety Rating Scale with a total score range of 0-56, where <17 indicates mild severity, 18-24 mild to moderate severity and 25-30 moderate to severe. We will compare the relationship between the severity of anxiety and the duration of levothyroxine treatment in hypothyroid patients and if there is improvement of anxiety with good control of treatment or not.	Baseline

Collaborators and Investigators

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

Sponsor

Assiut University

Investigators

Study Director: Ghada A Elkhateeb, Prof., Assiut University
Study Director: Romany H Gabra, A prof., Assiut University
Study Director: Dalia G Mohammed, Prof., Assiut University

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 (Actual)

January 27, 2025

Primary Completion (Estimated)

November 1, 2026

Study Completion (Estimated)

December 1, 2026

Study Registration Dates

First Submitted

October 10, 2024

First Submitted That Met QC Criteria

October 24, 2024

First Posted (Actual)

October 28, 2024

Study Record Updates

Last Update Posted (Actual)

March 25, 2025

Last Update Submitted That Met QC Criteria

January 31, 2025

Last Verified

October 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Fatigue in Hypothyroidism

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

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.

Study of Chronic Fatigue, Depression, and Anxiety Among Hypothyroid Patients Attending Assuit University Hospitals