ICAT clinical validation

ICAT clinical validation

Clinical validation in patients with bipolar disorder

About the project

Mood disorders such as major depressive disorder and bipolar disorder are among the costliest psychiatric disorders in Europe and constitutes a major health economic challenge. Cognitive impairment across memory, attention and executive function is a core feature in mood disorders and have repeatedly been found to persist after remission and be associated with daily functioning. Consequently, cognitive impairment is directly associated with socio-occupational disability and therefore contributes to poor quality of life for patients. This has led to increased research into the effect of potential treatment strategies that specifically target cognitive impairment in psychiatric illness. However, this research is often challenged by the lack of efficient screening tools that are capable of selecting participants that have clinically relevant cognitive impairments and therefore will benefit of a pro-cognitive treatment. With the Internet-based Cognitive Assessment Tool (ICAT), we seek to develop a tool that can address this challenge and simultaneously enable a faster and more efficient screening of trial candidates.

The ICAT was programmed to resemble the standardized paper-and-pencil neuropsychological test, Screening for Cognitive Impairment in Psychiatry (SCIP), and was tested in a small validation study with healthy participants in 2018 (Hafiz et al., 2019). The preliminary findings indicated that participants’ performance on the ICAT tests correlates moderately to strongly with their performance on the SCIP tests, suggesting that the ICAT is valid (albeit not optimal) for assessment of cognition. The aim of the present study is to conduct a new validation study on a larger (clinical) sample with an optimized version of the ICAT. This study will include both patients with bipolar disorder and healthy controls in order to assess if the ICAT can successfully discriminate between the two groups regarding cognitive impairment.

Both patients and healthy controls will be recruited from the ongoing Bipolar Illness Onset Study (Kessing et al., 2017) and tested with both SCIP and ICAT as part of the neuropsychological assessment included in the BIO-study. The validation study will run from June to October 2019 and the data collection will be conducted by research assistants supervised by Prof. Lars Vedel Kessing and Prof. Kamilla Woznica Miskowiak at the Copenhagen Affective Disorder Research Centre (CADIC).

Inclusion Criteria

Patients with a diagnosis of bipolar disorder and healthy controls with no current or prior psychiatric illness. The study will include participants between age 18-70 that speak Danish as their native language.

Exclusion Criteria

Healthy controls are excluded if they have any first-degree relatives (parents, siblings or children) with a history of psychiatric illness. For both groups, exclusion criteria include severe prior head trauma, dyslexia, neurological disorders, severe somatic illness and current substance or alcohol abuse.

Compensation

All participants will be offered feedback on their results and receive a gift card worth 250 kroner alongside a box of chocolate. 

Time Duration

The assessment will take 40 minutes to complete.

Who Will Have Access to Your Information?

Your name or identity will not be disclosed in reports or publications produced by the project. You can get, if you wish for access to your own data and results. Anonymized results from the project will be used for publications in scientific journals and presented at conferences.

Data Security

All data gathered by the test and recordings of the session are stored locally and no one would get access to it.

Informed Consent

You can read the informed consent form before starting the test and you are required to agree to the terms to continue.

Contact Information

For practical and technical questions, you can reach Pegah Hafiz at pegh@dtu.dk



Contact

Pegah Hafiz
Postdoc
DTU Health Tech
+45 45 25 34 19

Contact

Jakob Eyvind Bardram
Head of Sections, Professor
DTU Health Tech
+45 45 25 53 11
https://www.cachet.dk/research/studies/icat-clinical-validation
11 JULY 2020