Personalized exposure and ESM feedback versus exposure as usual for OCD: a study protocol for a randomized controlled trial

Abstract

Background This study aims to compare personalized exposure with response prevention (ERP) using experience sampling methodology-based feedback to ERP as usual in patients with obsessive-compulsive disorder (OCD). Personalized exposure will be provided screen-to-screen in an ecologically valid (real time and real place) context by means of a smartphone application. This app will also be used to collect both objective and subjective data by means of experience sampling methodology (ESM). This ESM-data will be used to identify triggers and protective factors for symptom severity, provide personalized feedback and optimize the effect of ERP. The primary goal of this RCT is to compare the effectiveness of personalized ERP to ERP as usual in the traditional context of a therapist’s room in patients with OCD in OCD symptom severity. Since both self-efficacy and experiential avoidance are known to influence symptom-severity in OCS, a secondary goal is to examine if a possible treatment effect is mediated by self-efficacy or experiential avoidance. Methods This study involves a randomized controlled trial with 20 weekly sessions by 2 groups (ERP as usual versus personalized ERP), repeated measurements at baseline (T0), 5 weeks of treatment (T1), 10 weeks of treatment (T2), 15 weeks of treatment (T3), posttest at 20 weeks (T4), 6 weeks follow-up (T5), 3 months follow-up (T6), 6 months follow-up (T7) and a year follow-up (T8). A hundred and sixty patients with an OCD diagnosis according to DSM-5 criteria will participate. Half of the group will receive exposure with response prevention as usual, the other half will receive personalized exposure with response prevention with a smartphone application and personalized feedback sessions based on experience sampling data. Discussion This randomized controlled trial is the first to assess the influence of delivering ERP through video calling and the use of an ESM intervention on the symptom severity of OCD. Since the global pandemic COVID-19, the use of video calling to deliver psychological treatments has become more common, increasing the relevance of this study. Trial registration: ICTRP Trial NL8254 registered on 2019-12-24 url: https://trialsearch.who.int/Trial2.aspx?TrialID=NL8254