2/2 Self-directed mobile adaptive coping skills intervention to improve psychological distress symptoms among cardiorespiratory failure survivors: the Blueprint RCT - Project Summary Cardiorespiratory conditions such as the acute respiratory distress syndrome (ARDS), congestive heart failure, COVID pneumonia, and sepsis are among the most common causes of mortality and morbidity. They are also notable for high rates of persistent psychological distress symptoms including depression, anxiety, and PTSD that worsen quality of life and outcomes of the underlying conditions. Yet there are few effective strategies able to overcome barriers of limited access to mental health care. Even less is known about distress management among people from structurally disadvantaged backgrounds such as racially and ethnically minoritized populations because of their suboptimal representation in relevant clinical trials. To fill this gap, we developed Blueprint, an adaptive coping skills training intervention, and have optimized it over years of research. We conducted a multicenter RCT (PCORI PFA 195) of a telephone- and web-based version among those recently hospitalized with serious cardiorespiratory conditions, finding that it reduced depression symptoms and improved quality of life among those with elevated baseline distress. Informed by lessons learned about intervention delivery and eligibility criteria, we next conducted a single-center pilot RCT (R34 HL145387) that targeted a broader population and tested a completely automated, self-guided, symptom-responsive mobile app version of Blueprint. We found excellent adherence and a strong effect on depression, anxiety, PTSD, and quality of life compared to control. Given these promising findings, a formal test of the Blueprint adaptive coping skills training intervention’s efficacy is needed. Therefore, we propose a 5-year multicenter RCT with 6-month follow up in which 400 cardiorespiratory failure survivors with elevated symptoms of psychological distress post-discharge are randomized to either Blueprint or an Education Program control, both delivered through similar mobile app platforms. Our specific aims will: (1) Test Blueprint vs. control on symptoms of depression, anxiety, PTSD, and quality of life; (2) Determine patient-level characteristics associated with a great treatment response among sociodemographic subgroups of interest, also applying a heterogeneity of treatment effects analysis to identify other groups of clinical relevance; and (3) Ensure off-the-shelf intervention readiness for implementation by using an exploratory mixed-methods hybrid type 1 implementation framework analysis that integrates semi-structured interviews with trial participants and quantitative trial data from Aims 1 and 2. This DCC proposal will provide the data management infrastructure and will maintain study integrity. Innovative elements include a fully automated mobile health delivery system that personalizes content in response to changes in symptom trajectories, a focus on racially and ethnically minoritized persons, the integration of a Spanish language intervention version, and strong community engagement. This project addresses national research priorities and could advance the field with a personalizable yet population- focused therapy that could be scaled broadly and efficiently to enhance mental health equity.
