@Article{info:doi/10.2196/34889, author="Leo, Ashwin J and Schuelke, Matthew J and Hunt, Devyani M and Metzler, John P and Miller, J Philip and Are{\'a}n, Patricia A and Armbrecht, Melissa A and Cheng, Abby L", title="A Digital Mental Health Intervention in an Orthopedic Setting for Patients With Symptoms of Depression and/or Anxiety: Feasibility Prospective Cohort Study", journal="JMIR Form Res", year="2022", month="Feb", day="21", volume="6", number="2", pages="e34889", keywords="digital health; mental health; depression; anxiety; chronic pain; musculoskeletal; orthopedic; pain management; health intervention; mobile phone", abstract="Background: Symptoms of depression and anxiety commonly coexist with chronic musculoskeletal pain, and when this occurs, standard orthopedic treatment is less effective. However, mental health intervention is not yet a routine part of standard orthopedic treatment, in part because of access-related barriers. Digital mental health intervention is a potential scalable resource that could be feasibly incorporated into orthopedic care. Objective: This study's primary purpose was to assess the feasibility of introducing a digital mental health intervention (Wysa) in an outpatient orthopedic setting to patients with coexisting symptoms of depression and/or anxiety. The secondary purpose was to perform a preliminary effectiveness analysis of the intervention. Methods: In this single-arm, prospective cohort study, participants included adult patients (18 years and older) who presented to a nonsurgical orthopedic specialist at a single tertiary care academic center for evaluation of a musculoskeletal condition and who self-reported symptoms of depression and/or anxiety (Patient-Reported Outcomes Measurement Information System [PROMIS] Depression and/or Anxiety score ≥55). Face-to-face enrollment was performed by a research coordinator immediately after the participant's encounter with an orthopedic clinician. Participants were provided 2 months of access to a mobile app called Wysa, which is an established, multicomponent digital mental health intervention that uses chatbot technology and text-based access to human counselors to deliver cognitive behavioral therapy, mindfulness training, and sleep tools, among other features. For this study, Wysa access also included novel, behavioral activation--based features specifically developed for users with chronic pain. Primary feasibility outcomes included the study recruitment rate, retention rate, and engagement rate with Wysa (defined as engagement with a therapeutic Wysa tool at least once during the study period). Secondary effectiveness outcomes were between-group differences in mean longitudinal PROMIS mental and physical health score changes at 2-month follow-up between high and low Wysa users, defined by a median split. Results: The recruitment rate was 29.3{\%} (61/208), retention rate was 84{\%} (51/61), and engagement rate was 72{\%} (44/61). Compared to low users, high users reported greater improvement in PROMIS Anxiety scores (between-group difference −4.2 points, 95{\%} CI −8.1 to −0.2; P=.04) at the 2-month follow-up. Between-group differences in PROMIS Depression (−3.2 points, 95{\%} CI −7.5 to 1.2; P=.15) and Pain Interference scores (−2.3 points, 95{\%} CI −6.3 to 1.7; P=.26) favored high users but did not meet statistical significance. Improvements in PROMIS Physical Function scores were comparable between groups. Conclusions: Delivery of a digital mental health intervention within the context of orthopedic care is feasible and has the potential to improve mental health and pain-related impairment to a clinically meaningful degree. Participants' engagement rates exceeded industry standards, and additional opportunities to improve recruitment and retention were identified. Further pilot study followed by a definitive, randomized controlled trial is warranted. Trial Registration: ClinicalTrials.gov NCT04640090; https://clinicaltrials.gov/ct2/show/NCT04640090 ", issn="2561-326X", doi="10.2196/34889", url="https://formative.jmir.org/2022/2/e34889", url="https://doi.org/10.2196/34889", url="http://www.ncbi.nlm.nih.gov/pubmed/35039278" }