Cognitive ImpairmentNCT06678412
Turkish Version of the Cognitive Functioning Self-Assessment Scale
An observational study of Cognitive Impairment, run by Kutahya Health Sciences University at 1 site in Turkey (Türkiye).
Trial summary
Self-report scales used in the assessment of cognitive functions can serve as an initial screening tool for the general population, aside from specific neuropsychiatric tests, which are more costly and time-consuming. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Cognitive Impairment
- How many people
- 180 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 20 Nov 2024to 3 Mar 2025
- 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 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: Healthy individuals over 18 years old
Who may be able to join
- Individuals over 18 years old
Who cannot join
- Taking antidepressants
- Having a neurological or psychiatric disease
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site
Kutahya Health Sciences University
Kütahya, 43100
About this study
Official title: The Validity and Reliability of the Turkish Version of the Cognitive Functioning Self-Assessment Scale
Self-report scales used in the assessment of cognitive functions can serve as an initial screening tool for the general population, aside from specific neuropsychiatric tests, which are more costly and time-consuming. This study is designed to examine the validity and reliability of the Turkish version of the Cognitive Functioning Self-Assessment Scale (CFSS). Permission for the study has been obtained from the developer of the scale, Dr. Maria Antonietta Annunziata. The Turkish translation of the scale will be made, and approval will be obtained from the original author for the final version. Subsequently, the Turkish version of the CFSS, the Hospital Anxiety and Depression Scale, and the Cognitive Failures Questionnaire will be administered to participants. Surveys will be completed either online via Google Forms or in written form. To assess the reliability of the scale, the Turkish version of the CFSS will be re-administered to the same participants 7-14 days later.
- Conditions
- Cognitive Impairment
- Keywords
- cognitive function, self-assessment, psychometrics
- Medical subject headings
- Cognitive Dysfunction
What is being measured
The primary outcome is the main question the study is designed to answer.
Cognitive Functioning Self-Assessment Scale (Turkish Vesion)
The "Cognitive Functioning Self-Assessment Scale" developed by Annunziata et al. in 2016, consists of 18 questions aimed at assessing cognitive function areas such as attention, memory, problem-solving, temporal-spatial orientation, and dual-task performance. Scoring is done on a 5-point Likert scale, ranging from 1 to 5. Higher scores on the scale indicate an increase in subjective cognitive complaints.
Measured: Baseline and 7-14 days after
Hospital Anxiety and Depression Scale (HADS)
The HADS was developed by Zigmond and Snaith in 1983. The HADS consists of a total of 14 items, including 7 items for anxiety and 7 items for depression. The items are scored between 0-3 points on a 4-point Likert-type scale according to how the individual felt in the previous week. The scores that can be obtained from anxiety and depression subscales vary between 0-21. The Turkish validity and reliability study of the scale was conducted by Aydemir et al. in 1997. High scores obtained from the scale indicate increased mood disorder.
Measured: Baseline
Cognitive Failures Questionnaire (CFQ)
The BDI is a self-report scale developed by Broadbent et al. in 1982 to assess cognitive failures that occur in daily life. Errors in perception, memory and motor functions are assessed with 25 questions. Each question is scored from 0 (never) to 4 (very often). The total score that can be obtained from the scale ranges from 0-100. Higher scores indicate an increased level of cognitive failure and worse cognitive status. The Turkish validity and reliability study of the scale was conducted by Ekici et al. in 2016.
Measured: Baseline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Nov 2024
- Study start20 Nov 2024
- Primary completion20 Feb 2025
- Study completion3 Mar 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Cognitive ImpairmentStudies of the same condition, open and under way.
- 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
- Cohort
- Time perspective
- Cross-sectional
- Enrolment
- 180 participants (actual)
Sponsor and investigators
- Lead sponsor
- Kutahya Health Sciences University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Ismail Okur, Kutahya Health Sciences University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06678412
- Sponsor's protocol ID
- KSBU 2024/11-09
- Status last verified
- Mar 2025
- First submitted
- 5 Nov 2024
- Last updated
- 10 Mar 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 10 Mar 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Validity and Reliability of the Turkish Version of the Cognitive Functioning Self-Assessment Scale
- ClinicalTrials.gov ID
- NCT06678412
- Acronym / sponsor ID
- KSBU 2024/11-09
- Conditions
- Cognitive Impairment
- Keywords
- cognitive function, self-assessment, psychometrics
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 180 participants (actual)
- Lead sponsor
- Kutahya Health Sciences UniversityUniversity, hospital or other
- Study start
- 20 Nov 2024 (actual)
- Primary completion
- 20 Feb 2025 (actual)
- Study completion
- 3 Mar 2025 (actual)
- First posted
- 7 Nov 2024 (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.
Self-report scales used in the assessment of cognitive functions can serve as an initial screening tool for the general population, aside from specific neuropsychiatric tests, which are more costly and time-consuming. This study is designed to examine the validity and reliability of the Turkish version of the Cognitive Functioning Self-Assessment Scale (CFSS). Permission for the study has been obtained from the developer of the scale, Dr. Maria Antonietta Annunziata. The Turkish translation of the scale will be made, and approval will be obtained from the original author for the final version. Subsequently, the Turkish version of the CFSS, the Hospital Anxiety and Depression Scale, and the Cognitive Failures Questionnaire will be administered to participants. Surveys will be completed either online via Google Forms or in written form. To assess the reliability of the scale, the Turkish version of the CFSS will be re-administered to the same participants 7-14 days later.
Study design
- Observational model
- Cohort
- Time perspective
- Cross-sectional
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Healthy individuals over 18 years old
Key inclusion criteria (1 listed)
- Individuals over 18 years old
Key exclusion criteria (2 listed)
- Taking antidepressants
- Having a neurological or psychiatric disease
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
Cognitive Functioning Self-Assessment Scale (Turkish Vesion)
Time frame: Baseline and 7-14 days after
The "Cognitive Functioning Self-Assessment Scale" developed by Annunziata et al. in 2016, consists of 18 questions aimed at assessing cognitive function areas such as attention, memory, problem-solving, temporal-spatial orientation, and dual-task performance. Scoring is done on a 5-point Likert scale, ranging from 1 to 5. Higher scores on the scale indicate an increase in subjective cognitive complaints.
Hospital Anxiety and Depression Scale (HADS)
Time frame: Baseline
The HADS was developed by Zigmond and Snaith in 1983. The HADS consists of a total of 14 items, including 7 items for anxiety and 7 items for depression. The items are scored between 0-3 points on a 4-point Likert-type scale according to how the individual felt in the previous week. The scores that can be obtained from anxiety and depression subscales vary between 0-21. The Turkish validity and reliability study of the scale was conducted by Aydemir et al. in 1997. High scores obtained from the scale indicate increased mood disorder.
Cognitive Failures Questionnaire (CFQ)
Time frame: Baseline
The BDI is a self-report scale developed by Broadbent et al. in 1982 to assess cognitive failures that occur in daily life. Errors in perception, memory and motor functions are assessed with 25 questions. Each question is scored from 0 (never) to 4 (very often). The total score that can be obtained from the scale ranges from 0-100. Higher scores indicate an increased level of cognitive failure and worse cognitive status. The Turkish validity and reliability study of the scale was conducted by Ekici et al. in 2016.
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 10 Mar 2025.
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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.
The record lists no contact. Use the official record to reach the sponsor.
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 Cognitive Impairment, run by Kutahya Health Sciences 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 1 inclusion and 2 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 10 Mar 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?
Cognitive Functioning Self-Assessment Scale (Turkish Vesion) (time frame: Baseline and 7-14 days after). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 10 Mar 2025.