G.T. MSRS On-Line Calculator Targeting the Early Diagnosis of Mixed Affective States: the Multicenter Study Project Design on the Approbation and Validity of the Three Language Versions of the Rating Scale.

Background: Mixed affective states (MS) are often misdiagnosed by the clinicians and lead to the inappropriate treatment strategies contributing to the severe forms, poor outcome with higher rates of comorbid conditions and worse remission quality in affective and bipolar disorders, as well as to a decreased psychosocial functioning of these patients. The development of reliable tools for the MS assessments or so called the phenomenon of mixity in affective disorders, is still an unmet need of psychiatric research and clinical practice. In this paper, we present PC program "Multilingual IBM-PC on-line calculator for early diagnosis of the mixed affective states" based on the Giuseppe Tavormina Mixed States Rating Scale (G.T. MSRS) (Russian, English, Italian language versions) created by the ICERN group using programming language JavaScript, working for such operation systems (OS) as Windows, Linux, MacOs, Android, iOS, and aims to contribute to the accurate assessment of the presence and severity of the mixed states among affective disorders.

Subjects And Methods: The G.T. Mixed States Rating Scale on-line calculator consists of 11 items which evaluate various aspects of MS in patients with major depression, bipolar or recurrent depressive disorder. A total score is automatically calculated, considering the type of affective temperament according to the Akiskal's and Tavormina's schemas, thus, the specific sub-groups of MS are differentiated based on the ranges: Medium-light (2-6), Medium (7-12), and High (13-19) Mixity level. The study will enroll 330 participants during two (three months follow-up) visits (110 native speakers in each of the three languages) of both genders aged from 18 till 55 y.o. with the diagnoses of depressive episodes, major depression, bipolar or recurrent depressive disorder according to the DSM-5 criteria. Assessments will be provided by the two investigators (second one will be blinded to the G.T. MSRS results obtained by the first researcher), based on the use of DSM-5 clinical interview, Young Mania Rating Scale, Montgomery-Åsberg Depression Rating Scale, Clinical Global Impression - Severity scale (CGI-S), Clinical Global Impression - Improvement scale (CGI-I), Patient Global Impression of Change (PGIC).

Results: The study will assess the agreement between the diagnostic category/clinical impression and the on-line G.T. MSRS calculator use results, its test-retest reliability, and diagnosis stability for further assessment of the on-line G.T. MSRS calculator validity and clinical utility. Secondary variables will evaluate internal reliability and such statistical analyses as Cronbach's alpha, Cohen's Kappa, biserial correction, and agreement between initial and follow-up diagnoses.

Conclusions: Current multicenter validation study of the on-line G.T. MSRS calculator will enhance the understanding of the mixity phenomenon and its clinical implication, aiming to improve the treatment strategies to manage the course of mental disorder, quality of life and psychosocial functioning in patients with affective (bipolar) disorders, accompanied by MS, and a clinical recommendation for the routine administration of the user-friendly on-line G.T. MSRS version in clinical practice.