Depression Inventory for Maintenance Hemodialysis Patients (Depression)

February 26, 2025 updated by: Nurten Ozen, Istanbul University

Depression Inventory for Maintenance Hemodialysis Patients: A Cross-Cultural Adaptation and Psychometric Evaluation in Turkey

Depression is frequently seen among hemodialysis patients; however, it causes an impaired quality of life, a decrease in adherence to treatment, and an increase in hospitalization and mortality rate. It has been stated in the literature that the prevalence rate of depression in hemodialysis patients varies between 25-73%. Despite its high prevalence rate and adverse effects, it has been revealed that only a low rate of patients with depressive symptoms are diagnosed and treated. This is primarily associated with the fact that depressive symptoms in patients are not adequately recognized and examined.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Detailed Description

Depression is assessed through structured clinical interviews or diagnostic scales. Structured clinical interviews are often regarded as the "gold standard" for the diagnosis of depressive disorders, since they are based on specific diagnostic criteria. However, since it is not always possible for patients to be evaluated by a psychiatrist, some scales are used instead. Even though these scales are not a diagnostic criterion, they are helpful in identifying patients at risk . However, screening may also result in false negatives, where cases of depression are not detected and, consequently, go untreated. Patients with kidney failure differ from the general population because they experience higher rates of comorbid depression. Indeed, there is a clear need for more effective screening tools for patients undergoing hemodialysis, given the wide variation in depression screening methods and the absence of a gold-standard assessment tool tailored to this specific population. Developing an easily administered, disease-specific self-report measure for depression could prove to be highly beneficial. There is only one study that has examined a depression tool specifically designed for patients on maintenance dialysis, known as the Depression Inventory-Maintenance Hemodialysis (DI-MHD)

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Observational

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
283

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

  • Turkey
      • İstanbul, Turkey, 34116
        • Nurten Özen

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

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Sampling Method

Non-Probability Sample

Study Population

Taking hemodialysis therapy in dialysis unit

Description

Inclusion Criteria:

  • Patients aged 18 years and older
  • Patients who were receiving hemodialysis treatment for at least three months
  • Patients could communicate in Turkish
  • Patients who agreed to participate in the study were included in the study.

Exclusion Criteria:

  • Patients who suffered from psychiatric disorders such as chronic psychosis and were previously diagnosed with depression were excluded from the study

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

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Predict of depression risk with questionnare
Time Frame: Up to 15 days
Depression Inventory for Maintenance Hemodialysis Patients The inventory, developed by the researchers consists of 17 items. In this four-point likert type scale; items are rated as never: 1 point, sometimes: 2 points, often: 3 points, and almost always: 4 points. Minimum and maximum scores of the inventory are 17 points and 68 points, respectively. Higher scores indicate that severity of fatigue increases. A score of 25 or more from the inventory indicates the presence of depression. At this cut-off point, the sensitivity and specificity of the inventory are 97% and 86%. The Cronbach's alpha value of the inventory is 0.893. The inventory has four subscales; low mood subscale: 7 items (7-28 points), inhibition of movement and thought subscale: 4 items (4-16 points), change in cognition subscale: 4 items (4-16 points), low self-evaluation subscale: 2 items (2-8 points). Higher scores mean that the situation reflected by the subscale worsens.
Up to 15 days

Collaborators and Investigators

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

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Istanbul University

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Nurten Ozen, Assoc. Prof., Istanbul 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 (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
April 1, 2022

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
August 1, 2022

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
August 1, 2022

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
February 20, 2025

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
February 20, 2025

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
March 25, 2025

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
March 25, 2025

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
February 26, 2025

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
February 1, 2025

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • ATADEK-2022/06

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

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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