ABSTRACT
Rationale: Cardiorespiratory diseases are common causes of persistent psychological distress symptoms. To fill this gap, we developed Blueprint, a month-long mobile app-based adaptive coping skills training intervention based on lessons learned about intervention delivery and population targeting from a multicenter RCT of a hybrid telephone- and web-based intervention (Figure). However, Blueprint requires further testing before broader use. Methods: The objectives were to (1) Optimize the usability of the new Blueprint system by incorporation of features based on lessons learned and (2) Test two Blueprint iterations vs. usual care in a pilot 3-arm RCT with 3-month follow up among a targeted sample of 45 patients. Usability was assessed using the Systems Usability Scale (SUS). The two Blueprint iterations differed by their response to weekly changes in Hospital Anxiety and Depression Scale (HADS) scores within the app (app-based response with additional digital content vs. therapist response). The key inclusion criterion was hospitalization in an ICU or stepdown unit with a need for cardiorespiratory support (e.g., ventilation, vasopressors) plus a HADS total score ≥8 just after arrival home. Method of minimization was used to balance across strata (ICU service, baseline HADS, age). The 1-month HADS score was the primary outcome, with secondary outcomes at 1 and 3 months including HADS, Post-Traumatic Stress Scale (PTSS), and physical symptoms (PHQ-10) Results: Usability testing was performed among 5 patients asked to perform core tasks in the Blueprint app. The mean (SD) SUS score was 83.5 (9.5), exceeding the benchmark target of 80. Subsequently, the RCT was initiated. A total of 1,133 were screened, 416 (37%) appeared to be eligible, 229 (55%) were approached, 65 (28%) consented, and 45 (69%) randomized in a 1:1:1 ratio by group. A total of 19 (29%) were excluded post-consent for low baseline HADS scores. To date, 25 have completed the trial and 20 are still active in the protocol. The relatively high refusal rate reflects the conduct of the RCT by the study team completely by distance via telephone and SMS texting (including screening and consenting) during the COVID pandemic. Conclusion: We successfully transformed an adaptive coping skills intervention into a highly usable, fully self-guided, mobile app-based version called Blueprint that delivers content responsive to weekly changes in psychological distress symptoms. We reached the target sample size and follow-up for the RCT continues. We anticipate completion by January 2022 with full results ready for presentation by the time of ATS 2022.
ABSTRACT
Background: The COVID-19 pandemic has led to extremely high levels of emotional distress and burnout amongst frontline healthcare workers. Rapidly deployable and scalable interventions are desperately needed to help combat the burgeoning mental health crisis among frontline healthcare works. Methods: We designed a prospective, randomized, waitlist-controlled pilot study assessing the impact of a mobile mindfulness app (LIFT) among nurses working in COVID-19 units. Participants were randomized in a 2:1 fashion to receive access to mobile mindfulness content (intervention) or to a waitlist to receive access to mobile mindfulness content outside the study period (control). All patients completed a survey that includes the Patient Health Questionairre-9 (PHQ-9), The General Anxiety Disorder-7 (GAD-7), the Perceived Stress Scale-4 (PSS-4), and the Maslach Burnout Index (MBI) at baseline (T1) and at the end of the study period (28 days after enrollment, T2). Primary outcomes are feasibility as assessed by the number of participants completing all 4 weeks of mindfulness therapy as well as the total number of daily mindfulness sessions completed. Secondary outcomes included change in PHQ-9, GAD-7, PSS-4, and MBI scores from T1 to T2. Results: Enrollment began in May of 2021. To date 82 participants have been enrolled and randomized, 56 to intervention and 24 to waitlist, with a target enrollment of 100. Median PHQ-9 scores in each group were 8 (IQR 6-11.25) and 7 (IQR 5-10) indicating moderate amounts of emotional distress in each group. Enrollment and follow-up are ongoing, with enrollment planned to be completed in December 2021. Conclusions: We have successfully enrolled 82 participants in an ongoing randomized, waitlist-controlled trial testing the clinical impact of a mobile mindfulness intervention on emotional distress and burnout in frontline healthcare workers. Final results will be presented at ATS International Meeting.