Abstract
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 singlecenter
pilot RCT (R34 HL 145387) 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.
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 populationfocused
therapy that could be scaled broadly and efficiently to enhance mental health equity.
