Interrelations between participant and intervention characteristics, process variables and outcomes in online interventions: A protocol for overarching analyses within and across seven clinical trials in ICare

Abstract

Background: It is well known that web-based interventions can be effective treatments for various conditions. Less is known about predictors, moderators, and mediators of outcome and especially interrelations between participant and interventions characteristics, process variables and outcomes in online interventions. Clinical trials often lack statistical power to detect variables that affect intervention effects and their interrelations. Within ICare, we can investigate the interrelation of potential predictor and process variables in a large sample. Method: The ICare consortium postulated a model of interrelations between participant and intervention characteristics, process variables and outcomes in online interventions. We will assess general and disorderspecific interrelations between characteristics of the intervention, characteristics of the participants, adherence, working alliance, early response, and intervention outcomes in a sample of over 7500 participants from seven clinical trials evaluating 15 online interventions addressing a range of mental health conditions and disorders, using an individual participant data meta-analyses approach. Discussion/conclusion: Existing research tends to support the efficacy of online mental health interventions, but the knowledge base regarding factors that affect intervention effects needs to be expanded. The overarching analyses using data from the ICare intervention trials will add considerably to the evidence.