JMIR Publications

ABSTRACT

Background:

The diagnosis of mental disorders, including depression, requires valid and reliable measures to correctly provide a diagnosis, identify comorbidities, and enable evidence-based treatments. For the evaluation of treatment outcomes, measures are required to be sensitive to change. Klenico is a comprehensive online-based diagnostic tool that combines patients' self-reports and clinical validations by mental health professionals and incorporates all prevalent mental disorders.

Objective:

The aim of this research is to further validate the Klenico system, specifically focusing on the examination of the Klenico Depression Domain, while assessing its reliability, construct validity, and sensitivity to change.

Methods:

Anonymized data from n = 496 patients in a psychotherapeutic inpatient clinic were used. Patients completed the Klenico assessment in addition to standard questionnaires (the PHQ, BDI-II, and SWLS) both at admission and discharge. Reliability was tested using Cronbach’s alpha. Construct validity was assessed through exploratory factor analyses and by Pearson’s correlation analysis with standard questionnaires. Sensitivity to change was determined based on changes in effect sizes and standardized mean responses.

Results:

The Klenico Depression Domain revealed excellent internal consistency (Cronbach’s alpha = 0.91). Factor analysis suggested a seven-factor structure. Its correlations with the PHQ-9 (r = 0.68, p < 0.001) and BDI-II (r = 0.70, p < 0.001) were strong, and its sensitivity to symptom change was high (t = 5.358, p < 0.001, Cohen’s d = 0.79).

Conclusions:

The Klenico Depression Domain emerges as an accurate and valid diagnostic tool, providing valuable real-life evidence for efficient and standardized assessments of depression. Its sensitivity in evaluating treatment outcomes further strengthens its utility in clinical settings.