Digital mental health intervention for orthopedic patients with symptoms of depression and/or anxiety: Pilot feasibility study (Preprint)

BACKGROUND Depression and anxiety commonly coexist with chronic musculoskeletal pain, and when this occurs, standard orthopedic treatment is less effective. Nevertheless, addressing mental health is not yet a routine part of standard orthopedic treatment, in part due to access related barriers. Digital mental health intervention offers the potential to be a scalable resource that could feasibly be incorporated into orthopedic care. OBJECTIVE The primary purpose of this study was to assess the feasibility of introducing a digital mental health intervention (Wysa) within an outpatient orthopedic setting to patients who endorse 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 non-surgical 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). Enrollment was performed face-to-face by a research coordinator immediately after the participant’s encounter with an orthopedic clinician. Participants were provided two months of access to a mobile app called Wysa, which is an established, multi-component 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 engaging 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 two-month follow-up between high Wysa users and low Wysa users, defined by a median split. RESULTS The recruitment rate was 61/208 (29%), retention rate was 51/61 (84%), and engagement rate was 44/61 (72%). Compared to low users, high Wysa users achieved greater improvement in PROMIS Anxiety (between-group difference -4.2 points [95% CI -8.1 to -0.2], P=.044) at two-month follow-up. Between-group differences in PROMIS Depression (-3.2 points [-7.5 to 1.2], P=.15) and Pain Interference (-2.3 points [-6.3 to 1.7], P=.26) favored high users but did not meet statistical significance. Improvements in PROMIS Physical Function were comparable between groups. CONCLUSIONS Delivery of a digital mental health intervention within the context of orthopedic care is feasible and demonstrates 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. CLINICALTRIAL ClinicalTrials.gov NCT202005219