NCT06113029

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

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
118

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Dec 2023

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

October 26, 2023

Completed
7 days until next milestone

First Posted

Study publicly available on registry

November 2, 2023

Completed
29 days until next milestone

Study Start

First participant enrolled

December 1, 2023

Completed
10 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 30, 2024

Completed
1 day until next milestone

Study Completion

Last participant's last visit for all outcomes

October 1, 2024

Completed
Last Updated

November 27, 2023

Status Verified

November 1, 2023

Enrollment Period

10 months

First QC Date

October 26, 2023

Last Update Submit

November 23, 2023

Conditions

Keywords

DepressionAnxietyliver

Outcome Measures

Primary Outcomes (1)

  • Number of participants that experienced depressive or anxiety disorders

    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

Study Arms (2)

Healthy group

Participants not known to have neither chronic liver diseases nor Psychiatric disorders

Diagnostic Test: The Hamilton Rating Scale for AnxietyDiagnostic Test: The Beck Depression inventoryDiagnostic Test: Rand SF-36 Questionnaire

Diseased group

Participants known to have chronic liver diseases

Diagnostic Test: The Hamilton Rating Scale for AnxietyDiagnostic Test: The Beck Depression inventoryDiagnostic Test: Rand SF-36 Questionnaire

Interventions

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).

Diseased groupHealthy group

one of the most widely used instruments for measuring the severity of depression

Diseased groupHealthy group

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 groupHealthy group

Eligibility Criteria

Age18 Years - 90 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
Study Population

Patients with chronic liver diseases

You may qualify if:

  • 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.
  • age group above 18 years old.

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Salma Ashraf Mohamed Badr

Asyut, 71745, Egypt

Location

Related Publications (3)

  • Vahia VN. Diagnostic and statistical manual of mental disorders 5: A quick glance. Indian J Psychiatry. 2013 Jul;55(3):220-3. doi: 10.4103/0019-5545.117131. No abstract available.

    PMID: 24082241BACKGROUND
  • Kessler RC, Berglund P, Demler O, Jin R, Merikangas KR, Walters EE. Lifetime prevalence and age-of-onset distributions of DSM-IV disorders in the National Comorbidity Survey Replication. Arch Gen Psychiatry. 2005 Jun;62(6):593-602. doi: 10.1001/archpsyc.62.6.593.

    PMID: 15939837BACKGROUND
  • Huang X, Liu X, Yu Y. Depression and Chronic Liver Diseases: Are There Shared Underlying Mechanisms? Front Mol Neurosci. 2017 May 8;10:134. doi: 10.3389/fnmol.2017.00134. eCollection 2017.

    PMID: 28533742BACKGROUND

MeSH Terms

Conditions

DepressionAnxiety Disorders

Condition Hierarchy (Ancestors)

Behavioral SymptomsBehaviorMental Disorders

Study Design

Study Type
observational
Observational Model
CASE CONTROL
Time Perspective
RETROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal investigator

Study Record Dates

First Submitted

October 26, 2023

First Posted

November 2, 2023

Study Start

December 1, 2023

Primary Completion

September 30, 2024

Study Completion

October 1, 2024

Last Updated

November 27, 2023

Record last verified: 2023-11

Data Sharing

IPD Sharing
Will share

Locations