DepressionDepressionNCT06844890
Depression Inventory for Maintenance Hemodialysis Patients
An observational study of Depression and Hemodialysis Complication, run by Istanbul University at 1 site in Turkey (Türkiye).
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Depression, Hemodialysis Complication, Management
- How many people
- 283 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 1 Apr 2022to 1 Aug 2022
- How long will I take part?
- 15 Days
- 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 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Taking hemodialysis therapy in dialysis unit
Who may be able to join
- 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.
Who cannot join
- Patients who suffered from psychiatric disorders such as chronic psychosis and were previously diagnosed with depression were excluded from the study
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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.
Read the 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)
- Conditions
- Depression, Hemodialysis Complication, Management, Risk Behavior
- Keywords
- depression, dialysis, management
- Medical subject headings
- Depression, Risk-Taking
What is being measured
The primary outcome is the main question the study is designed to answer.
Predict of depression risk with questionnare
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.
Measured: Up to 15 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Feb 2025
- Study start1 Apr 2022
- Primary completion1 Aug 2022
- Study completion1 Aug 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for DepressionStudies of the same condition, open and under way.
- More trials run by Istanbul 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
- Other
- Time perspective
- Prospective
- Enrolment
- 283 participants (actual)
- Target duration
- 15 Days
Sponsor and investigators
- Lead sponsor
- Istanbul University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Nurten Ozen, Istanbul University
- Investigators
- Nurten Ozen, Assoc. Prof., Principal investigator, Istanbul University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06844890
- Sponsor's protocol ID
- ATADEK-2022/06
- Acronym
- Depression
- Status last verified
- Feb 2025
- First submitted
- 20 Feb 2025
- Last updated
- 28 Feb 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
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.
PubMed 30239119Palmer 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.
PubMed 23486521
Study at a glance
From the registry record, last updated by the sponsor on 28 Feb 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Depression Inventory for Maintenance Hemodialysis Patients: A Cross-Cultural Adaptation and Psychometric Evaluation in Turkey
- ClinicalTrials.gov ID
- NCT06844890
- Acronym / sponsor ID
- Depression / ATADEK-2022/06
- Conditions
- Depression, Hemodialysis Complication, Management, Risk Behavior
- Keywords
- depression, dialysis, management
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 283 participants (actual)
- Lead sponsor
- Istanbul UniversityUniversity, hospital or other
- Study start
- 1 Apr 2022 (actual)
- Primary completion
- 1 Aug 2022 (actual)
- Study completion
- 1 Aug 2022 (actual)
- First posted
- 25 Feb 2025 (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.
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.
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 design
- Observational model
- Other
- Time perspective
- Prospective
- Target follow-up
- 15 Days
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Taking hemodialysis therapy in dialysis unit
Key inclusion criteria (4 listed)
- 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.
Key exclusion criteria (1 listed)
- Patients who suffered from psychiatric disorders such as chronic psychosis and were previously diagnosed with depression were excluded from the study
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
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.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Feb 2025.
- Background: PubMed 30239119Wang 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.
- Results publication: PubMed 23486521Palmer 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.
- Individual participant dataSharing planned: No
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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.
Nurten Ozen, Assoc. Prof. principal investigator
Istanbul University
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 and Hemodialysis Complication, run by Istanbul University at 1 site in Turkey (Türkiye).
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 4 inclusion and 1 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: finished, as of the sponsor's last update on 28 Feb 2025. 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 Turkey (Türkiye). 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Predict of depression risk with questionnare (time frame: Up to 15 days). 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 NCT06844890, which also lists 2 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 28 Feb 2025.