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

NCT06660888 | Enrolling By Invitation

• 1 other identifier: Fatigue in Hypothyroidism
• Study Type: observational
• Target: 406
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Hypothyroidism Primary

Keywords

Fatigue; Depression; Anxiety

Outcome Measures

Primary Outcomes (3)

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

  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.

  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.

  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 Outcomes (3)

• Compare the severity of chronic fatigue according to the duration and control of treatment in patients with hypothyroidism.

  Baseline

• Compare the severity of depression according to the duration and control of treatment in patients with hypothyroidism.

  Baseline

• Compare the severity of anxiety according to the duration and control of treatment in patients with hypothyroidism.

  Baseline

Interventions

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

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.

Eligibility Criteria

• Age: 18 Years - 60 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)
• Sampling Method: Non-Probability Sample

Study Population

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

You may qualify if:

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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Assiut University: lead

Study Sites (1)

Assuit university hospitals

Asyut, Assuit, Egypt

Location

Related Publications (8)

• Udovcic M, Pena RH, Patham B, Tabatabai L, Kansara A. Hypothyroidism and the Heart. Methodist Debakey Cardiovasc J. 2017 Apr-Jun;13(2):55-59. doi: 10.14797/mdcj-13-2-55.

  PMID: 28740582 BACKGROUND

• Sethi B, Barua S, Raghavendra MS, Gotur J, Khandelwal D, Vyas U. The Thyroid Registry: Clinical and Hormonal Characteristics of Adult Indian Patients with Hypothyroidism. Indian J Endocrinol Metab. 2017 Mar-Apr;21(2):302-307. doi: 10.4103/ijem.IJEM_387_16.

  PMID: 28459030 BACKGROUND

• Evans KM, Flanagan DE, Wilkin TJ. Chronic fatigue: is it endocrinology? Clin Med (Lond). 2009 Feb;9(1):34-8. doi: 10.7861/clinmedicine.9-1-34.

  PMID: 19271598 BACKGROUND

• Ruiz-Pacheco MG, Hernandez I, Hernandez-Estrella G, Basurto L, Vargas-Ortega G, Gonzalez-Virla B, Molina-Ayala M, Hernandez-Martinez AF, Luengas-Mondragon R, Hernandez-Allende AA, Mendoza-Zubieta V, Balcazar-Hernandez L. Severity of Fatigue and Its Relationship with TSH before and after Levothyroxine Replacement Therapy in Patients with Primary Hypothyroidism. Biomedicines. 2023 Mar 7;11(3):811. doi: 10.3390/biomedicines11030811.

  PMID: 36979787 BACKGROUND

• Chaker L, Razvi S, Bensenor IM, Azizi F, Pearce EN, Peeters RP. Publisher Correction: Hypothyroidism. Nat Rev Dis Primers. 2022 Jun 10;8(1):39. doi: 10.1038/s41572-022-00373-7. No abstract available.

  PMID: 35688906 BACKGROUND

• Nassar M, Hassan A, Ramadan S, Desouki MT, Hassan MA, Chaudhuri A. Evaluating the effectiveness of combined T4 and T3 therapy or desiccated thyroid versus T4 monotherapy in hypothyroidism: a systematic review and meta-analysis. BMC Endocr Disord. 2024 Jun 14;24(1):90. doi: 10.1186/s12902-024-01612-6.

  PMID: 38877429 BACKGROUND

• Ali ZH, Abdulridha MK, Alzajaji QB. Screening factors affecting proper levothyroxine therapy among patients with primary hypothyroidism: a cross-sectional study. J Med Life. 2024 Feb;17(2):177-187. doi: 10.25122/jml-2023-0387.

  PMID: 38813351 BACKGROUND

• Hage MP, Azar ST. The Link between Thyroid Function and Depression. J Thyroid Res. 2012;2012:590648. doi: 10.1155/2012/590648. Epub 2011 Dec 14.

  PMID: 22220285 BACKGROUND

MeSH Terms

Conditions

Hypothyroidism; Fatigue; Depression; Anxiety Disorders

Condition Hierarchy (Ancestors)

Thyroid Diseases; Endocrine System Diseases; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Behavioral Symptoms; Behavior; Mental Disorders

Study Officials

• Ghada A Elkhateeb, Prof.

  Assiut University

  STUDY DIRECTOR

• Romany H Gabra, A prof.

  Assiut University

  STUDY DIRECTOR

• Dalia G Mohammed, Prof.

  Assiut University

  STUDY DIRECTOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Target Duration: 1 Day
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Resident Doctor at Family Medicine Department

Study Record Dates

• First Submitted: October 10, 2024
• First Posted: October 28, 2024
• Study Start: January 27, 2025
• Primary Completion (Estimated): November 1, 2026
• Study Completion (Estimated): December 1, 2026
• Last Updated: February 4, 2025

Record last verified: 2024-10

Data Sharing

• IPD Sharing: Will not share

Locations

EG (1)