T-RAC: Study Protocol for Assessing the Acceptability and Preliminary Efficacy of Adding an Exergame-Augmented Dynamic Imagery Intervention to the Behavioural Activation Treatment of Depression

Abstract

Background: Improving the existent effective treatments of depression is a promising way to optimise the effects of psychological treatments. Here we examine the effects of adding a rehabilitation type of imagery based on exergames and dynamic simulations to a short behavioural activation treatment of depression. We investigate the acceptability and the efficacy of an exergame-augmented dynamic imagery intervention added to behavioural activation treatment and associated mechanisms of change.Methods and analyses: In a two-arm pilot randomised controlled trial, the acceptability and preliminary efficacy of an exergame-augmented dynamic imagery intervention added to behavioural activation treatment for depressed individuals will be assessed. Participants (age 18–65) meeting criteria for depression will be recruited by media and local announcements. 110 participants will be randomly allocated to behavioural activation plus imagery group or to standard behavioural activation group. The primary outcome is depressive symptom severity (Beck Depression Inventory II) and secondary outcomes are anhedonia, apathy and behavioural activation and avoidance. The outcomes are assessed at baseline, mid treatment, posttreatment and 3-month follow-up. Moderation and mediation analyses will be explored. An intention-to-treat approach with additional per-protocol analysis will be used for data analysis.Ethics and dissemination: This trial is approved by the ethics committee of the Faculty of Socio-Humanistic Sciences of University of Oradea (no.: 2394/18.11.2022). Informed consent is required from participants before enrollment in the study. The results will be submitted for publication in peer-reviewed journals and presented at conferences.Trial registration number: This trial was registered in the Clinical Trials Register: NCT05625230.