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Enrolling by invitation Observational

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

NCT06660888 · tracked via the Priya Life Science Egypt tracker
Phase
Observational
Started
2025-01-27
Last updated
2025-02-04

Condition(s) studied

Hypothyroidism Primary

Investigational drug(s) / intervention(s)

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

• Fatigue Severity Scale (FFS). • Hamilton Rating Scale for Depression (HRSD-17). • Hamilton Anxiety Rating Scale (HAM-A).: 1. 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. 2. Hamilton Depression Rating Scale The 17-item Hamilton Depression Rating Scale (HRSD-17) is the most popular depression measure in antidepressant clinical trials. 3. Hamilton Anxiety Rating Scale The HAM-A was one of the first rating scales developed to measure the severity of anxiety symptoms.

Study summary

* 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.

Eligibility

Sex
ALL
Min age
18 Years
Max age
60 Years
Healthy volunteers
No
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.

Primary outcome measure(s)

  • Prevalence of chronic fatigue in patients with hypothyroidism at Assuit University Hospitals. — 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.
  • Prevalence of depression in patients with hypothyroidism at Assuit University Hospitals. — 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
  • Prevalence of anxiety in patients with hypothyroidism at Assuit University Hospitals. — 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.

Trial sites (1)

FacilityCityRegionStatus
Assuit university hospitals Asyut Assuit
Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT06660888 on ClinicalTrials.gov ↗ ← All trials in Egypt