Course overview: The course provides a comprehensive introduction to trial design features used to mitigate bias, important aspects of trial design, conduct, analysis and reporting, and challenges and solutions for conducting RCTs with some focus on behavioural interventions. This will include some coverage of methods for elucidation of treatment mechanisms (e.g. mediation). Throughout the course the emphasis will be on practical issues faced by researchers in the conduct and analysis of RCTs through the lens of the mental health setting, and participants will be provided with skills to design, conduct and analyse rigorous RCTs in this research area.

Requirements: Some practical sessions will involve analyses and interpretation using practice data sets using the Stata and/or R programs. Stata and R syntax will be provided and explained, but some familiarity with software, especially Stata, is necessary, and individuals should have some knowledge of fitting regression models. Successful participants will need to bring their own laptop computer to the course with working installations of: 1) Stata version 14 or higher, 2) the R program.

Learning outcomes:

• Subject specific: Knowledge, Understanding and Skills
• On successful completion of this course the student should be able to:
• Understand the key sources of bias within study designs
• Understand the fundamental features of a clinical trial within a mental health framework and potential challenges
• Implement suitable clinical trial designs for different settings
• Perform some robust analysis of clinical trial data and disseminate results
• General: Knowledge, Understanding and Skills
• On successful completion of this module the student should be able to:
• Communicate ideas effectively and professionally by written, oral and visual means
• Interact effectively in a group
• To be able to work competently and independently as well as reflect on their practice