Depression, AnxietyNCT06113029
Depressive and Anxiety Disorders in Patients With Chronic Liver Diseases
An observational study of Depression, Anxiety, run by Assiut University at 1 site in Egypt.
Trial summary
The aim of this observational study is to learn about the prevalence of depressive and anxiety disorders among patients with chronic liver diseases Read more about this study
- Who is it for?
- Ages 18 to 90 yearsHealthy volunteers can take part
- Conditions the study is for
- Depression, Anxiety
- What is being tested?
- The Hamilton Rating Scale for Anxiety, The Beck Depression inventory and Rand SF-36 Questionnaire
- How many people
- 118 participants
- Where
- 1 siteEgypt
- Study dates
- 1 Dec 2023to 1 Oct 2024
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 90 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: Patients with chronic liver diseases
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
Egypt1 site
Salma Ashraf Mohamed Badr
Asyut, 71745
Salma Ashraf Mohamed Badr, MBBCH, 01026134363, salmabestawy1997@gmail.com
About this study
Official title: 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
Read the 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.
- Conditions
- Depression, Anxiety
- Being tested
- The Hamilton Rating Scale for Anxiety, The Beck Depression inventory, Rand SF-36 Questionnaire
- Keywords
- Depression, Anxiety, liver
- Medical subject headings
- Depression, Anxiety Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
The Hamilton Rating Scale for AnxietyDiagnostic test
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).
The Beck Depression inventoryDiagnostic test
one of the most widely used instruments for measuring the severity of depression
Rand SF-36 QuestionnaireDiagnostic test
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
| Study group | Role | What they receive |
|---|---|---|
| Healthy group | Participants not known to have neither chronic liver diseases nor Psychiatric disorders Receives: Diagnostic Test: The Hamilton Rating Scale for Anxiety; Diagnostic Test: The Beck Depression inventory; Diagnostic Test: Rand SF-36 Questionnaire | |
| Diseased group | Participants known to have chronic liver diseases Receives: Diagnostic Test: The Hamilton Rating Scale for Anxiety; Diagnostic Test: The Beck Depression inventory; Diagnostic Test: Rand SF-36 Questionnaire |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: Baseline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Nov 2023
- Study start1 Dec 2023 (estimated)
- Primary completion30 Sep 2024 (estimated)
- Study completion1 Oct 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Depression, AnxietyStudies of the same condition, open and under way.
- More trials run by Assiut UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case-control
- Time perspective
- Retrospective
- Enrolment
- 118 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Assiut University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Salma Ashraf Mohamed Badr, Assiut University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06113029
- Sponsor's protocol ID
- Depression and liver
- Status last verified
- Nov 2023
- First submitted
- 26 Oct 2023
- Last updated
- 27 Nov 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes
Publications
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.
PubMed 24082241Kessler 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.
PubMed 15939837Huang 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.
PubMed 28533742
Study at a glance
From the registry record, last updated by the sponsor on 27 Nov 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prevalence of Depressive Disorders and Anxiety Disorders Among Sample of Patients With Chronic Liver Disease Attending Assiut University Hospitals.
- ClinicalTrials.gov ID
- NCT06113029
- Acronym / sponsor ID
- Depression and liver
- Conditions
- Depression, Anxiety
- Keywords
- Depression, Anxiety, liver
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 118 participants (estimated)
- Lead sponsor
- Assiut UniversityUniversity, hospital or other
- Study start
- 1 Dec 2023 (estimated)
- Primary completion
- 30 Sep 2024 (estimated)
- Study completion
- 1 Oct 2024 (estimated)
- First posted
- 2 Nov 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The aim of this observational study is to learn about the prevalence of depressive and anxiety disorders among patients with chronic liver diseases
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
- Observational model
- Case-control
- Time perspective
- Retrospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Healthy group | – | Diagnostic Test: The Hamilton Rating Scale for Anxiety, Diagnostic Test: The Beck Depression inventory, Diagnostic Test: Rand SF-36 QuestionnaireParticipants not known to have neither chronic liver diseases nor Psychiatric disorders |
| Diseased group | – | Diagnostic Test: The Hamilton Rating Scale for Anxiety, Diagnostic Test: The Beck Depression inventory, Diagnostic Test: Rand SF-36 QuestionnaireParticipants known to have chronic liver diseases |
Who may qualify
- Ages
- 18 to 90 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Patients with chronic liver diseases
Key inclusion criteria (2 listed)
- 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.
Key exclusion criteria (4 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| The Hamilton Rating Scale for AnxietyThe 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 | Diseased group, Healthy group |
| The Beck Depression inventoryone of the most widely used instruments for measuring the severity of depression | Diagnostic test | Diseased group, Healthy group |
| Rand SF-36 QuestionnaireThe 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 | Diagnostic test | Diseased group, Healthy group |
Primary outcome
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
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Nov 2023.
- Background: PubMed 24082241Vahia 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.
- Background: PubMed 15939837Kessler 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.
- Background: PubMed 28533742Huang 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.
- Individual participant dataSharing planned: Yes
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Depression, Anxiety, run by Assiut University at 1 site in Egypt.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 27 Nov 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Egypt. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of participants that experienced depressive or anxiety disorders (time frame: Baseline). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06113029, which also lists 3 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 27 Nov 2023; AzTrials last refreshed its copy on 8 Nov 2026.