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Enrolling by Invitation

NCT Number: NCT06660888

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

* Assessment of the prevalence of chronic fatigue, depression, and anxiety among patients with hypothyroidism in Assuit University Hospital. * Assess the severity of chronic fatigue, depression, and anxiety according to the duration and control of treatment in patients with hypothyroidism.

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Key information

Conditions

Hypothyroidism Primary Anxiety Disorders Behavior Behavioral Symptoms Depression Endocrine System Diseases Fatigue Hypothyroidism Mental Disorders Pathological Conditions, Signs and Symptoms Signs and Symptoms Thyroid Diseases

Age range

18 year–60 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Assuit university hospitals

Asyut, Assuit, Egypt

About this study

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.

Who can participate

Healthy volunteers accepted: No

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

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.

Treatment and study plan

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

Behavioral
  • Fatigue Severity Scale The FSS is one of the most commonly used fatigue questionnaires in chronic diseases. It measures how fatigue affects motivation, exercise, physical functioning, carrying out duties, work, family, or social life.
  • Hamilton Depression Rating Scale The 17-item Hamilton Depression Rating Scale (HRSD-17) is the most popular depression measure in antidepressant clinical trials.
  • Hamilton Anxiety Rating Scale The HAM-A was one of the first rating scales developed to measure the severity of anxiety symptoms.

Primary outcomes

  1. 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.

  2. 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

  3. 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.

Secondary outcomes

  1. 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.

  2. 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.

  3. 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.

Sponsors and collaborators

Lead sponsor

Assiut University

Other

Registry information

Important dates

Study start
2025
Primary completion
2026
Study completion
2026
First posted
Oct 28, 2024
Registry last updated
Feb 4, 2025

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.

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