Depressive and Anxiety Disorders in Patients With Chronic Liver Diseases

Sponsor
Assiut University (Other)
Overall Status
Not yet recruiting
CT.gov ID
NCT06113029
Collaborator
(none)
118
1
11
10.7

Study Details

Study Description

Brief Summary

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

Condition or Disease Intervention/Treatment Phase
  • Diagnostic Test: The Hamilton Rating Scale for Anxiety
  • Diagnostic Test: The Beck Depression inventory
  • Diagnostic Test: Rand SF-36 Questionnaire

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 Design

Study Type:
Observational
Anticipated Enrollment :
118 participants
Observational Model:
Case-Control
Time Perspective:
Retrospective
Official Title:
Prevalence of Depressive Disorders and Anxiety Disorders Among Sample of Patients With Chronic Liver Disease Attending Assiut University Hospitals.
Anticipated Study Start Date :
Nov 1, 2023
Anticipated Primary Completion Date :
Sep 30, 2024
Anticipated Study Completion Date :
Oct 1, 2024

Arms and Interventions

Arm 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

Outcome Measures

Primary Outcome Measures

  1. Number of participants that experienced depressive or anxiety disorders [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

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years to 90 Years
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
Yes
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.

Contacts and Locations

Locations

Site City State Country Postal Code
1 Salma Ashraf Mohamed Badr Assiut Egypt 71745

Sponsors and Collaborators

  • Assiut University

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

Responsible Party:
Salma Ashraf Mohamed Badr, Principal investigator, Assiut University
ClinicalTrials.gov Identifier:
NCT06113029
Other Study ID Numbers:
  • Depression and liver
First Posted:
Nov 2, 2023
Last Update Posted:
Nov 2, 2023
Last Verified:
Oct 1, 2023
Individual Participant Data (IPD) Sharing Statement:
Yes
Plan to Share IPD:
Yes
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Keywords provided by Salma Ashraf Mohamed Badr, Principal investigator, Assiut University
Additional relevant MeSH terms:

Study Results

No Results Posted as of Nov 2, 2023