- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT07527234
ECCA's Turkish Validity and Reliability Study and Comparison With Other Cognitive Assessment Tests
"Conducting a Turkish Validity and Reliability Study of the Electroconvulsive Therapy Cognitive Assessment (ECCA) and Comparing it With Other Cognitive Function Assessment Tests."
Electroconvulsive therapy (ECT) is one of the oldest biological treatment methods used in psychiatry, based on inducing widespread seizures in the brain with externally applied controlled electrical currents. It was first applied in 1938 by Italian physician Ugo Cerletti and his assistant Lucio Bini. A 1974 report by the American Psychiatric Association stated that ECT was effective in treating depression, mania, and refractory schizophrenia, and it is still used today as an effective and safe method, particularly in the treatment of severe major depression, catatonia, schizophrenia, and mania.
Although the exact mechanism of action of ECT is not fully understood, it is suggested that it increases brain receptor sensitivity, accelerates serotonin and dopamine metabolism, activates monoaminergic systems, regulates the circadian rhythm, and provides synchronization between brain hemispheres. In addition, it has been shown to affect neurotransmitter levels, neuroendocrine responses, and neurogenesis processes.
Anterograde and retrograde amnesia are among the cognitive side effects that can be seen in the subacute phase of ECT. While anterograde amnesia usually resolves within a few months after treatment, retrograde amnesia can be permanent in some cases. Therefore, assessment of cognitive function before, during, and after ECT is recommended.
In clinical practice, the Montreal Cognitive Assessment (MoCA) and the Mini-Mental State Test (MMSE) are frequently used for cognitive assessment. However, these scales were not developed to assess ECT-specific cognitive effects and may be limited in detecting retrograde memory loss, autobiographical memory impairments, and subjective memory complaints. Therefore, there is a need for more sensitive tools that can assess ECT-specific cognitive side effects.
The Electroconvulsive Cognitive Assessment Test (ECCA), developed for this purpose by Adriana P. Hermida and colleagues from the Department of Psychiatry and Behavioral Sciences at Emory University in Atlanta, is a structured assessment tool consisting of 30 items. The test; The ECCA assesses five cognitive domains: subjective memory, caregiver-assessed memory, attention, autobiographical memory, and delayed verbal recall. A study in the UK compared the ECCA with the MoCA and showed that the ECCA may be more sensitive in assessing cognitive function in individuals undergoing ECT. Similarly, a study in China reported that the ECCA was more sensitive than the MMSE and MoCA in assessing cognitive changes in patients with major depressive disorder after ECT.
In conclusion, the limitations of current tools in assessing cognitive function during ECT necessitate the development of ECT-specific measurement tools. In this context, the ECCA is considered an important tool for clinical decision-making and post-treatment cognitive monitoring.
Scales are measurement tools used to classify and rate the characteristics to be measured. Scale adaptation studies save time compared to developing a new scale and allow the use of common data collection tools in different cultures. Therefore, conducting validity and reliability studies of tests is of great scientific importance.
To conduct a validity and reliability study of the ECCA test in Turkey, the necessary permission was obtained from the test developer, Adriana Hermida. During the translation process, the test was translated from English to Turkish by five independent individuals, and then back-translated by five different individuals. The translations were compared to ensure consistency, and the process was also verified by a sworn translator.
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
Electroconvulsive therapy (ECT) is considered one of the first biological treatment methods used in psychiatry and is based on the induction of generalized seizures in the brain through the application of controlled external electrical current.(1)
The first use of electroconvulsive therapy (ECT) as a psychiatric treatment method was carried out in 1938 by the Italian physician Ugo Cerletti.(2) The application of electrical current to induce convulsions by Cerletti and his assistant Lucio Bini marked an important turning point in the field of psychiatry.(3)
In 1974, a task force of the American Psychiatric Association reported that ECT was beneficial in the treatment of depression, mania, and treatment-resistant schizophrenia. Since 1938, it has been applied as one of the most effective treatment options in the management of mental illnesses.(1)
Electroconvulsive therapy (ECT) is used as an effective and safe intervention in the treatment of various psychiatric disorders, particularly severe major depression, as well as catatonia, schizophrenia, and mania.(4,5)
Various theoretical explanations have been proposed regarding the mechanism of action of electroconvulsive therapy (ECT).(6) In this context, it has been suggested that ECT increases the sensitivity of brain receptors, accelerates serotonin and dopamine metabolism, activates monoaminergic systems, regulates circadian rhythm, and provides synchronization between the two brain hemispheres.(6) In addition to its antidepressant, antipsychotic, anticonvulsant, and anticatatonic effects, ECT has also been shown to have significant effects on neurotransmitter levels, neuroendocrine responses, and neurogenesis processes.(6) However, the neurobiological mechanisms through which ECT exerts its therapeutic effects have not yet been fully clarified.(6)
Among the cognitive side effects that may occur during the subacute period of electroconvulsive therapy (ECT) are anterograde amnesia, which affects the learning of new information, and retrograde amnesia, which causes difficulty in recalling previously acquired information. It has been reported that anterograde amnesia generally resolves within two months after the completion of ECT treatment. However, there is evidence suggesting that retrograde amnesia may be permanent in some cases. These cognitive effects may not be immediately noticeable during ECT sessions and may persist after the treatment. Therefore, it is recommended that cognitive functions be carefully evaluated before, during, and after ECT administration.(5)
In clinical practice, the Montreal Cognitive Assessment (MoCA) and the Mini-Mental State Examination (MMSE) are frequently used to evaluate the cognitive side effects of electroconvulsive therapy (ECT).(5,7) These scales have been shown to be effective screening tools, particularly in the early diagnosis of mild cognitive impairment and Alzheimer's disease.(5,7) However, MoCA and MMSE were not specifically developed to evaluate ECT-related cognitive effects such as retrograde memory loss, autobiographical memory impairment, and subjective memory complaints.(5,7) Therefore, it is considered that existing cognitive assessment tools may be insufficiently sensitive in detecting cognitive side effects specific to ECT, and there is a need for a new cognitive assessment instrument specifically designed for ECT with higher sensitivity.(5,7)
The Electroconvulsive Cognitive Assessment (ECCA) Test, developed to evaluate ECT-related cognitive side effects, is a structured assessment tool consisting of 30 items and was designed in Atlanta.(8) The test aims to evaluate five main cognitive domains: subjective memory, informant-rated memory, attention, autobiographical memory, and delayed verbal recall. The ECCA was developed by Dr. Adriana P. Hermida and her colleagues from the Department of Psychiatry and Behavioral Sciences at Emory University.(8)
In a study conducted in the United Kingdom in 2020, the Electroconvulsive Cognitive Assessment (ECCA) Test and the Montreal Cognitive Assessment (MoCA) were compared in a sample of 131 participants.(8) The findings indicated that ECCA may have higher sensitivity than MoCA in evaluating cognitive functions in individuals undergoing ECT. Considering the difficulties encountered in monitoring and assessing cognitive side effects caused by ECT, ECCA is considered to have the potential to fill an important clinical gap due to its rapid applicability, ECT-specific structure, and multidimensional evaluation capacity.(8)
The fact that ECCA particularly focuses on autobiographical memory and subjective cognitive difficulties makes it more than a classical neuropsychological assessment tool and allows it to reflect early cognitive effects of ECT in a more comprehensive and holistic manner. Previous studies have also shown that memory impairments occurring during and after the ECT process have significant effects on individuals' overall cognitive functioning.(8)
In a study conducted in China, ECCA initially demonstrated greater sensitivity than MMSE or MoCA in evaluating changes in general cognitive levels in patients with major depressive disorder after ECT.(7)
In conclusion, the limitations of existing assessment tools used to monitor cognitive functions during the ECT process make it necessary to develop assessment instruments specific to ECT. In this context, ECCA stands out as a functional and valuable reference tool both in clinical decision-making processes and in cognitive monitoring after treatment.(8)
Scales are measurement tools that define the rules and constraints required to classify, rank, or determine the quantity and degree of the characteristics to be measured.(9)
Scale adaptation provides time savings compared to developing a new scale and enables the use of common data collection tools across different cultures. This allows for more generalizable data and facilitates research on similarities and differences between societies.(10)
The validity and reliability of Turkish versions of tests are critical for ensuring their scientific accuracy and consistency.(11) Validity refers to the degree to which a test accurately measures the characteristic it is intended to measure, whereas reliability indicates the consistency and stability of the test.(12) High reliability shows that the test produces consistent results, while validity determines whether the test actually measures what it is intended to measure.(13) The relationship between these two concepts indicates that a valid test must also be reliable, although a reliable test may not always be valid.(14) For example, high reliability does not necessarily mean that a test is valid; the appropriateness of the test for its intended purpose must also be evaluated.(15) In this context, validity and reliability analyses of Turkish tests are important for determining their psychometric properties and ensuring their effective use in educational processes.(11)
In order to conduct the validity and reliability study of the ECCA test in Türkiye, the developer of the test, Adriana Hermida, was contacted via e-mail. During the translation process, the ECCA test was translated from English into Turkish by five individuals independently of each other; subsequently, the Turkish version was back-translated into English by five different individuals who were also unaware of each other's translations. In order to evaluate the translations and ensure consistency, approval was also obtained from a sworn translator. In addition, official permission for the Turkish validity and reliability study was obtained from Adriana Hermida.
Study Type
Enrollment (Estimated)
Contacts and Locations
Study Locations
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Denizli, Turkey (Türkiye)
- Pamukkale Univercity
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
Sampling Method
Study Population
Description
Inclusion Criteria:A sample of 90 patients, aged 18-65, had an indication for ECT according to DSM-5 diagnostic criteria.
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Exclusion Criteria:Intellectual disability, cognitive impairments, history of neurological disease, substance abuse, illiteracy, diagnosis of dementia.
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Study Plan
How is the study designed?
Design Details
Cohorts and Interventions
Group / Cohort |
Intervention / Treatment |
|---|---|
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ect patients
patients who have received ECT indication
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The ElectroConvulsive Therapy Cognitive Assessment (ECCA) is a brief cognitive assessment tool specifically developed to evaluate cognitive functions in patients undergoing electroconvulsive therapy (ECT).
In this study, the Turkish version of the ECCA will be administered to assess its validity and reliability and to compare its performance with other neuropsychological assessment tools.
The intervention in this study refers to the administration of the ECCA as an assessment instrument rather than a therapeutic procedure.
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
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ecca test
Time Frame: periprocedural
|
The Electroconvulsive Cognitive Assessment (ECCA) is a brief cognitive assessment tool developed to evaluate cognitive functions in patients receiving electroconvulsive therapy (ECT).
It is designed to assess cognitive domains that may be affected by ECT, including memory, attention, and subjective cognitive complaints.
The test is used to monitor cognitive changes during the course of ECT treatment.
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periprocedural
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
ace-r test
Time Frame: periprocedural
|
ACE-R (Addenbrooke's Cognitive Examination-Revised) is a brief cognitive assessment tool used to evaluate multiple cognitive domains.
It assesses attention and orientation, memory, verbal fluency, language, and visuospatial abilities.
It is commonly used in clinical practice to screen for cognitive impairment and to help differentiate between various types of dementia.
The test provides a broader evaluation than shorter screening tools and usually takes around 15-20 minutes to administer.
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periprocedural
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moca test
Time Frame: periprocedural
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The Montreal Cognitive Assessment (MoCA) is a brief screening test used to evaluate cognitive functions.
It assesses several domains including attention, memory, language, visuospatial skills, executive functions, abstraction, calculation, and orientation.
It is commonly used to detect mild cognitive impairment and other cognitive disorders.
The test usually takes about 10-15 minutes to complete
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periprocedural
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Other Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Mini-Mental State Examination (MMSE)
Time Frame: periprocedural
|
The Mini-Mental State Examination (MMSE), also known as the Mini-Mental Test, is a brief cognitive screening tool used to assess cognitive functioning.
It evaluates orientation, attention, memory, language, and basic visuospatial skills.
It is commonly used in clinical settings to screen for cognitive impairment and to monitor changes in cognitive status over time.
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periprocedural
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Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: Melike C Balcı Şengül, Pamukkale Üniversitesi Psikiyatri HASTANESİ
Publications and helpful links
General Publications
- McCall WV, Andrade C, Sienaert P. Searching for the mechanism(s) of ECT's therapeutic effect. J ECT. 2014 Jun;30(2):87-9. doi: 10.1097/YCT.0000000000000121.
- Hebbrecht K, Giltay EJ, Birkenhager TK, Sabbe B, Verwijk E, Obbels J, Roelant E, Schrijvers D, Van Diermen L. Cognitive change after electroconvulsive therapy in mood disorders measured with the Montreal Cognitive Assessment. Acta Psychiatr Scand. 2020 Nov;142(5):413-422. doi: 10.1111/acps.13231. Epub 2020 Sep 21.
- Hermida AP, Goldstein FC, Loring DW, McClintock SM, Weiner RD, Reti IM, Janjua AU, Ye Z, Peng L, Tang YL, Galendez GC, Husain MM, Maixner DF, Riva-Posse P, McDonald WM; National Network of Depression Centers ECT Task Group. ElectroConvulsive therapy Cognitive Assessment (ECCA) tool: A new instrument to monitor cognitive function in patients undergoing ECT. J Affect Disord. 2020 May 15;269:36-42. doi: 10.1016/j.jad.2020.03.010. Epub 2020 Mar 4.
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Estimated)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Other Study ID Numbers
- E-60116787-020-719863
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
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