Blueprint 2: A self-directed mobile adaptive coping skills intervention to improve psychological distress symptoms among cardiorespiratory failure survivors study protocol

INTRODUCTION: Persistent psychological distress including symptoms of depression, anxiety, and posttraumatic stress disorder (PTSD) occur in as many as 70% of intensive care unit (ICU) survivors. However, few therapies exist that target this population's unique symptoms and needs. To address this, we developed the Blueprint adaptive coping skills mobile app, which was found to be feasible and reduce psychological distress symptoms in a recent single-center pilot randomized control trial (RCT). OBJECTIVE: To describe the methods of the Blueprint 2 multi-center RCT (clinicaltrials.gov ID NCT06538246) being conducted to test the efficacy of the Blueprint app in reducing psychological distress among ICU survivors compared to an education control in a geographically and sociodemographically diverse population, including Spanish-language speakers. METHODS AND ANALYSIS: In this RCT, 400 participants with a baseline Hospital Anxiety and Depression Scale (HADS) total score ≥ 8 will be randomized in a 1:1 ratio to intervention or control. The HADS total score at one month post-randomization is the primary outcome. Secondary outcomes include HADS anxiety and depression subscales, posttraumatic stress scale (PTSS), and the quality-of-life EQ-5D 100-point visual analog scale (VAS) at 1, 3, and 6 months. Select subgroup analyses including users of the Spanish-language version of the app will be used to evaluate consistency of effects across patient populations. Constrained longitudinal data analyses will compare outcomes across intervention groups and timepoints.