Strategies to improve the quality and usefulness of mental health trials in humanitarian settings.

A striking rise in the number of people affected by humanitarian crises has led to an increase in mental health and psychosocial support interventions to reduce the psychological effects of such crises. In a parallel trend, researchers have brought increased methodological rigour to their evaluation of these interventions. However, several methodological issues still constrain the quality and real-world relevance of the existing evidence base. We examine five core challenges in randomised controlled trials of mental health and psychosocial support interventions with conflict-affected and disaster-affected populations. These challenges are: translating intervention effects into metrics of real-world significance; giving adequate consideration to the selection and monitoring of control conditions; following rigorous processes to ensure outcome measures are culturally appropriate and psychometrically sound; ensuring and monitoring implementation variables, including fidelity, exposure, participant engagement, and the competence of implementation staff; and assessing mechanisms of change.