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Beyond RCTs—Better Research Designs and Methods for Psychosocial Efficacy Studies in Mental Health
Tania Lecomte, Ian Raugh, Meryl Caiada, Mahesh Menon
Background
Classic 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.
Objectives
This 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.
Results
New 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.
Conclusion
By 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.
Better Ways to Study Psychosocial Treatments for Mental Health
Psychosocial interventions play an important role in supporting people living with various mental health conditions, yet it can be difficult to study their effects using traditional research methods. Randomized controlled trials are often seen as the best way to test treatments, but they are not always well suited to psychosocial approaches, which depend on individual preferences, engagement, real-world settings, and flexible delivery. This review describes a range of alternative research designs that can help better evaluate non-medical treatments and programs for people with mental health conditions who can be difficult to recruit for large studies, such as those with schizophrenia or psychosis. These include studies that closely track changes within individuals over time, methods that capture experiences in daily life using smartphones or digital sensors, approaches that compare groups receiving different services in real-world settings, and newer trial designs that adapt to participants’ needs or preferences as the study progresses. By using research methods that are better aligned with how psychosocial treatments are delivered and experienced, researchers can generate more meaningful and applicable evidence. Expanding the range of study designs may ultimately improve the development, evaluation, and implementation of psychosocial interventions, leading to more effective and person-centred care for people affected by mental health conditions.