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CLINICAL SIGNIFICANCE AND EFFICACY IN MENTAL HEALTH CLINICAL TRIALS

Abstract

To develop and refine mental health interventions, it’s critical that we assess their significance in clinical trials and allow comparisons between various studies and methods. Consistency in reporting clinical significance and efficacy ensures that we can determine if the intervention makes a meaningful impact on participants’ lives and facilitates progress in the field. This study aimed to determine how many clinical trials for psychology evaluate and apply both of these in a quantifiable way, specifically focusing on standardized mean difference (SMD) for standardized units and reliable change index (RCI) for clinical significance. Our systematic review included 4 prominent journals that published clinical trials in 2020-2023 and recorded whether they reported these measures. We found that studies were inconsistent in reporting clinical significance and, when reported, methods varied greatly. Results from 225 published clinical trials in psychology revealed that 55.6% of the studies reported an SMD and just 22.5% included the RCI. There were 8 distinct methods used to compute the SMD and 7 distinct methods used for RCI. This study highlights the need for more consistency in clinical trials to measure and report standardized effect sizes and clinical significance. Standardizing these practices would provide a more accurate and detailed look at how well interventions work in studies and improve comparability between clinical trials.

Acknowledgements

KSU Radow College of Humanities & Social Sciences, KSU First Year & Sophomore Scholars Programs

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