Depressive and Anxiety Disorders in Patients With Chronic Liver Diseases

November 23, 2023 updated by: Salma Ashraf Mohamed Badr, Assiut University

Prevalence of Depressive Disorders and Anxiety Disorders Among Sample of Patients With Chronic Liver Disease Attending Assiut University Hospitals.

The aim of this observational study is to learn about the prevalence of depressive and anxiety disorders among patients with chronic liver diseases

Study Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

Detailed Description

Major depressive disorder (MDD), or clinical depression, is a psychiatric disorder characterized by 2 or more weeks of persistently depressed mood accompanied by symptoms such as feelings of worthlessness, guilt, hopelessness, helplessness, loss of self-esteem, sleep disturbance, changes in oral intake, anhedonia, loss of interest, and suicidality. The american psychiatric association, on the definition of anxiety, describes anxiety as the anticipated anticipation of a future danger or negative event, accompanied by feelings of dysphoria or physical symptoms of tension. The elements exposed to risk may belong both to the internal world and to the external world. depression is highly prevalent globally and is a leading cause of disability. The global burden of disease study found depression to be a leading cause of disability among all illnesses. Liver cirrhosis is one of the diseases commonly associated with depression.chronic liver disease is the progressive destruction and regeneration of the liver parenchyma leading to fibrosis and cirrhosis (normally lasts 6 months). The etiologic agents of CLD include hepatotropic viruses (HBV and HCV), fatty liver, alcohol, autoimmune hepatitis, etc. The mortality of CLD patients remains high not only due to irreversible cirrhosis, but also multiple complications such as HCC and mental disease, especially depression. The progressive nature of this disease results in high rates of hospitalization, extensive exposure to medications, increased financial burden, frequent need for invasive procedures, changes in body image, and an increase in morbidity and mortality. All these factors contribute to the physical and psychological stress that mediates the development of depressive symptom high rates of depression have been documented in patients with decompensated liver disease and in those anticipating liver transplantation.

Study Type

Observational

Enrollment (Estimated)

118

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
      • Assiut, Egypt, 71745

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
  • Older Adult

Accepts Healthy Volunteers

Yes

Sampling Method

Probability Sample

Study Population

Patients with chronic liver diseases

Description

Inclusion Criteria:

  1. patients admitted or attending at Rajhi university hospital with chronic liver disease including: viral (hepatitis B and C), autoimmune (primary biliary cirrhosis, primary sclerosing cholangitis and autoimmune hepatitis), non-alcoholic steatohepatitis, Morbus Wilson and cryptogenic CLD.
  2. age group above 18 years old.

Exclusion Criteria:

  1. patients with chronic liver disease with other psychiatric disorders other than depression and anxiety.
  2. patients with acute complication of chronic liver disease.
  3. patients with chronic liver disease who underwent liver transplation.
  4. patients with chronic liver disease under antiviral therapy.

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
Healthy group
Participants not known to have neither chronic liver diseases nor Psychiatric disorders
Diagnostic test: The Hamilton Rating Scale for 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).
Diagnostic test: The Beck Depression inventory
one of the most widely used instruments for measuring the severity of depression
Diagnostic test: Rand SF-36 Questionnaire
The SF-36 measures eight scales: physical functioning (PF), role physical (RP), bodily pain (BP), general health (GH), vitality (VT), social functioning (SF), role emotional (RE), and mental health (MH). Component analyses showed that there are two distinct concepts measured by the SF-36: a physical dimension, represented by the Physical Component Summary (PCS), and a mental dimension, represented by the Mental Component Summary (MCS). All scales do contribute in different proportions to the scoring of both PCS and MCS measures
Diseased group
Participants known to have chronic liver diseases
Diagnostic test: The Hamilton Rating Scale for 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).
Diagnostic test: The Beck Depression inventory
one of the most widely used instruments for measuring the severity of depression
Diagnostic test: Rand SF-36 Questionnaire
The SF-36 measures eight scales: physical functioning (PF), role physical (RP), bodily pain (BP), general health (GH), vitality (VT), social functioning (SF), role emotional (RE), and mental health (MH). Component analyses showed that there are two distinct concepts measured by the SF-36: a physical dimension, represented by the Physical Component Summary (PCS), and a mental dimension, represented by the Mental Component Summary (MCS). All scales do contribute in different proportions to the scoring of both PCS and MCS measures

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Number of participants that experienced depressive or anxiety disorders
Time Frame: Baseline
Each participant will be asked to fill items of questionnaires like The Beck Depression inventor, The Hamilton Rating Scale for Anexity and Rand SF-36 Questionnaire
Baseline

Collaborators and Investigators

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

Sponsor

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 (Estimated)

December 1, 2023

Primary Completion (Estimated)

September 30, 2024

Study Completion (Estimated)

October 1, 2024

Study Registration Dates

First Submitted

October 26, 2023

First Submitted That Met QC Criteria

October 31, 2023

First Posted (Actual)

November 2, 2023

Study Record Updates

Last Update Posted (Actual)

November 27, 2023

Last Update Submitted That Met QC Criteria

November 23, 2023

Last Verified

November 1, 2023

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • Depression and liver

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

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.

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