Deprexis® Acceptability study in REal life (DARE): study design

Abstract

Introduction Depression is a leading cause of disability, worldwide. Recently, WHO highlighted the negative impact of recent crises (COVID-19 pandemic, war in Ukraine, economic crisis). Although most international guidelines recommend psychotherapies as first-line treatment of depression, access remains scarce in France due to limited availability of trained clinicians (notably those with CBT certification), high cost for patient in a context of non-reimbursement and fear of stigmatization (Coldefy M. HCAA, 2022/04,19). Therefore, online blended psychological treatment such as deprexis® could increase access to care for people with depression. It presents several advantages such as easy access, scalability, and a proven efficacy (Twomey et al. PLoS One. 2020;15(1):e022810). Objectives This study aims to test real-life acceptability of deprexis® for people with depression in France outside a reimbursement pathway. Primary objective of this cross-sectional study is to measure acceptability of deprexis® a new digital therapy in France. Questionnaire includes acceptability of deprexis® assessed with patient willingness to complete deprexis® course, reasons of refusal, when needed, demographics and depression characteristics. The secondary objectives are to study 1/ acceptability according to type of center (Hospital based, Community Based or private practice) and type of practitioners (psychiatrists or psychologists), 2/ differences in acceptability according to severity’s level (evaluated with PHQ 9), 3/ differences in acceptability according to administration or not of a treatment (including psychotherapy), 4/ differences in acceptability according to prescriber’s profile (age, sex, place and type of practice), 5/ identification of reasons for refusal , and 6/ analyze refusal rate over time. Methods DARE is as a cross-sectional study in which deprexis® is suggested to any patient meeting the inclusion criteria over the fixed inclusion period June-December 2022 Inclusion criteria are: 1/ depression, 2/ age between 18 and 65 years, 3/ speak French sufficiently, 4/ access to Internet with a device to connect to deprexis® platform. Exclusion criteria are diagnosis of bipolar disorder, psychotic symptoms and/or suicidal thoughts during the current episode. All investigators received a video-based training on deprexis® before inclusion to make sure they all have same level of information and understanding on the program. Results The study is currently recruiting. Data will be available for EPA congress. Conclusions It is a first time a digital therapy is completing the current therapeutic options for the treatment of depression in France. Acceptability of this innovation by both patients and Healthcare providers is a first step. DARE may allow to have a better understanding of the acceptability of a digital therapy in the treatment of depression in France and identify the different factors influencing it in a natural setting. Disclosure of Interest O. Amiot Consultant of: Ethypharm Digital Therapy, A. H. Clair Consultant of: Ethypharm Digital Therapy, P. Courtet Consultant of: Ethypharm Digital Therapy, E. Fakra Consultant of: Ethypharm Digital Therapy, V. Narboni Employee of: Ethypharm Digital Therapy, F. Gheysen Consultant of: Ethypharm Digital Therapy, E. Haffen Consultant of: Ethypharm Digital Therapy, D. Drapier Consultant of: Ethypharm Digital Therapy, L. Lecardeur Consultant of: Ethypharm Digital Therapy