A Digital Mental Health Intervention in an Orthopedic Setting for Patients With Symptoms of Depression and/or Anxiety: Feasibility Prospective Cohort Study

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.