Change in DSM-5 Alcohol Use Disorder Criteria Count and Severity Level as a Treatment Outcome Indicator: Results from a Randomized Trial.

Abstract

Most clinical trials evaluating treatments for alcohol use target individuals meeting diagnostic criteria for alcohol use disorder (AUD), but few address change in diagnostic status following treatment or as a potential outcome indicator. This study evaluated whether DSM-5 AUD total criteria count or severity category was sensitive to change over time and treatment effects. Data were drawn from a randomized clinical trial that evaluated the efficacy of computer-based cognitive behavioral therapy program (CBT4CBT) for AUD. Sixty-eight individuals were randomized to 1 of the 3 weekly outpatient treatments for an 8-week period: (i) treatment as usual (TAU), (ii) TAU+CBT4CBT, and (iii) CBT4CBT+brief monitoring. Structured clinical interviews were used to determine current (past 30days) AUD diagnosis at baseline, end-of-treatment, and 6months following end-of-treatment. Change in the total number of DSM criteria endorsed, as well as severity categories (mild, moderate, severe), was evaluated across time and by treatment condition. Generalized Poisson's linear mixed models revealed a significant reduction in the number of DSM criteria from baseline to treatment end point [time effect χ2 (1)=35.54, p<0.01], but no significant interactions between time and treatment condition. Fewer total criteria endorsed, as well as achieving at least a 2-level reduction in AUD severity category at end-of-treatment, were associated with better outcomes during follow-up. Chi-square results indicated a greater proportion of individuals assigned to TAU+CBT4CBT had at least a 2-level reduction in severity category compared to TAU, at trend-level significance [χ2 (2, 54)=5.13, p=0.07], consistent with primary alcohol use outcomes in the main trial. This is the first study to demonstrate change in DSM-5 AUD total criteria count, as well as severity category, in a randomized clinical trial. These findings offer support for their use as a potential clinically meaningful outcome indicator.