Re-evaluating Insomnia Severity Index in Clinical Trials
Key Findings and Practical Solutions
Background: The Insomnia Severity Index (ISI) is commonly used to assess insomnia severity, but different research findings have led to variations in defining meaningful within-individual change (MWIC) for treatment response.
Methods: We analyzed data from two large clinical trials of lemborexant to improve the validation of ISI. By using a two-factor solution based on 6 items, we determined the MWIC through different methods, including anchor-based, distribution-based, and ROC curve approaches.
Results: The 6-item two-factor scale demonstrated better psychometric properties than the 7-item scale, and a 5-point reduction in the ISI total score was identified as the MWIC for individuals with insomnia in our patient sample.
Conclusions: Our findings highlight the potential limitations of the 7-item ISI scale and propose a more effective 6-item scale with a defined MWIC. It’s important to consider the generalizability of these results to similar patient populations.
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