Beyond RCTs—Better Research Designs and Methods for Psychosocial Efficacy Studies in Mental Health

BackgroundClassic randomized controlled trials (RCTs) are considered the gold standard in mental health research but, given their multiple limitations and threats to external validity, alternative trial designs may be more suitable in many circumstances.ObjectivesThis narrative review explores research designs and methodologies that can be useful to researchers interested in investigating the effects of psychosocial or other non-medical interventions for psychiatric conditions.ResultsNew or better-tailored methods have been developed over the years, including: improved RCTs with adaptive designs (e.g., microRCT, SMART, RAR, target-emulation, adaptive dose-response), randomized baseline single case experimental designs; experience sampling method; E-technology (e.g., sensors for movement, social media monitoring with natural language processing); matched cohort studies and cluster randomized trials; and partially randomized preference trials, as well as mixed-methods and hybrid effectiveness/implementation trials.ConclusionBy expanding the scope of recommended methods, above and beyond classic RCTs, the field can more easily determine the impact of psychosocial treatments in mental health research.