- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT06844890
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
Completed
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
Observational
Enrollment (Actual)
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
-
-
-
İstanbul, Turkey, 34116
- Nurten Ozen
-
-
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
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
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
Investigators
- 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
- Wang YY, Zhang WW, Feng L, Gao D, Liu C, Zhong L, Ren JW, Wu YZ, Huang L, Fu LL, He YN. Development and Preliminary Validation of a Depression Assessment Tool for Maintenance Hemodialysis Patients. Ther Apher Dial. 2019 Feb;23(1):49-58. doi: 10.1111/1744-9987.12749. Epub 2018 Sep 21.
- Palmer S, Vecchio M, Craig JC, Tonelli M, Johnson DW, Nicolucci A, Pellegrini F, Saglimbene V, Logroscino G, Fishbane S, Strippoli GF. Prevalence of depression in chronic kidney disease: systematic review and meta-analysis of observational studies. Kidney Int. 2013 Jul;84(1):179-91. doi: 10.1038/ki.2013.77. Epub 2013 Mar 13.
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)
April 1, 2022
Primary Completion (Actual)
August 1, 2022
Study Completion (Actual)
August 1, 2022
Study Registration Dates
First Submitted
February 20, 2025
First Submitted That Met QC Criteria
February 20, 2025
First Posted (Actual)
March 25, 2025
Study Record Updates
Last Update Posted (Actual)
March 25, 2025
Last Update Submitted That Met QC Criteria
February 26, 2025
Last Verified
February 1, 2025
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID 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.
Clinical Trials on Depression
-
Massachusetts General HospitalRecruitingDepression | Depression - Major Depressive Disorder | Depression Chronic | Depression in Adults | Depression Disorders | Depression DisorderUnited States
-
University of California, San FranciscoNational Center for Complementary and Integrative Health (NCCIH)Active, not recruitingDepression Moderate | Depression Mild | Depression, TeenUnited States
-
ProgenaBiomeWithdrawnDepression | Depression, Postpartum | Depression, Anxiety | Depression Moderate | Depression Severe | Clinical Depression | Depression in Remission | Depression, Endogenous | Depression ChronicUnited States
-
Sorlandet Hospital HFUniversity of Oslo; Karolinska Institutet; Australian Catholic University; Helse...RecruitingAnxiety | Anxiety Depression | Depression Anxiety Disorder | Depression - Major Depressive DisorderNorway
-
Washington University School of MedicineCompletedTreatment Resistant Depression | Late Life Depression | Geriatric Depression | Refractory Depression | Therapy-Resistant DepressionUnited States, Canada
-
Lipocine Inc.CompletedDepression, Postpartum | Postnatal Depression | Peripartum Depression | Depression, Post-Partum | Postpartum Depression (PPD) | Post-Natal DepressionUnited States
-
Kintsugi Mindful Wellness, Inc.Sonar Strategies; Vituity PsychiatryActive, not recruitingDepression | Depression Moderate | Depression Severe | Depression MildUnited States
-
Kintsugi Mindful Wellness, Inc.Sonar Strategies; Kolby Walker, DO; Brittany KimbleRecruitingDepression | Depression Moderate | Depression Severe | Depression MildUnited States
-
University of CincinnatiNational Center for Complementary and Integrative Health (NCCIH)RecruitingMild DepressionUnited States
-
University of MinnesotaCompletedDepression SymptomsUnited States