Randomized Controlled Trials of Psychological Interventions

URL study guide

https://studiegids.vu.nl/en/courses/2024-2025/P_MRANCON

Course Objective

The aim of this course is to have an understanding of the major methodological issues in designing a randomized controlled trial (RCT) of a psychological intervention in mental health care. Students should be able to identify strengths and weaknesses of the designs of published trials and be able to design a trial themselves.

Course Content

The course focuses on: the research questions which can be answered by a RCT, types of RCTs, design of a RCT according to the CONSORT statement (e.g. phrasing of the research question, choice of control group, blinding, randomization, power analysis, in
- and exclusion criteria, measuring outcomes, treatment integrity),analyzing and presenting data (including how to deal with missing data), and economical analyses. Furthermore, we discuss medical ethical issues in performing a trial as well as practical aspects of carrying out a RCT.

Teaching Methods

There are lectures twice a week. The lectures consists of theory but there are also assignments as well as presentations by other researchers running a RCT.

Method of Assessment

There is an exam with open-end questions. Students also have to write a research proposal of a RCT (pre-specified format). The final grade is the average of the exam grade and the grade for the paper. Both the exam and the paper have to be sufficient (5.5 or higher).

Literature

Everitt B.S. & Wessely S. (2008; 2nd edition) Clinical trials in psychiatry. New York Oxford University press; journal papers (handed out in class).