Intent-to-Treat vs. Non-Intent-to-Treat Analyses under Treatment Non-Adherence in Mental Health Randomized Trials

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A review of different approaches to the intention-to-treat principle in research design, with particular emphasis on mental health.

  • Format Texts
  • Language/s English
  • Target Audience Further education, Researchers
  • Duration >15 mins

Key Concepts addressed



The intent-to-treat (ITT) principle has long been mandated by the Food and Drug Administration (FDA) as the primary design and analysis strategy for industry clinical trials and also has been adopted widely in government-funded randomized clinical trials. Intent-to-treat analysis aims to estimate the effect of treatment as offered, or as assigned.

This analysis entails comparisons of randomized groups and outcome data for all randomized participants regardless of their status regarding non-adherence to assigned treatment protocols and missed assessment encounters.

“The first to be addressed is the analytic approach under the ITT principle. Next, we discuss various Non-ITT analyses, including the as-treated, per-protocol, and instrumental variable analyses. Finally, we present four examples in the mental health literature that highlight the differences among these approaches.”



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