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

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

Delivery of a Mental Health Intervention for Chronic Pain Through an Artificial Intelligence–Enabled App (Wysa): Protocol for a Prospective Pilot Study

“…Moreover, apart from using a conversational flow tailored for chronic pain, it also provides participants with a wide array of self-care tools they can use to deal with other issues like insomnia, depression, anxiety, and negative thoughts anytime they want [ 59 , 85 , 86 ]. Wysa for Chronic Pain has proven high engagement and efficacy when the intervention uses a conversational agent enhanced by a human coach [ 87 ]. This study aims to assess the efficacy of this intervention using the conversational agent alone.…”

“…Adherence is key to benefiting from a self-management program. To address this potential problem and promote adherence, the app has been built using the principles of behavioral activation, which are supported conversationally and have specific customizations for chronic pain [ 87 ].…”

Digital Mental Health Intervention Plus Usual Care Compared With Usual Care Only and Usual Care Plus In-Person Psychological Counseling for Orthopedic Patients With Symptoms of Depression or Anxiety: Cohort Study

“…This was a retrospective study that involved ancillary analysis of data collected from a single-arm pilot feasibility study and other existing medical record data (ClinicalTrials.gov NCT04640090) [ 14 ]. All patients were evaluated within the orthopedic department of a single tertiary care academic medical center (Washington University) in the United States between 2017 and 2021.…”

“…The primary cohort of interest included patients who enrolled in a single-arm, prospective cohort, pilot feasibility study in which they received 2 months of complimentary access to a digital mental health intervention (Wysa), in addition to their usual orthopedic care. The intervention and this cohort have previously been described [ 14 ]. In brief, Wysa is a multi-component mobile app based on the principles of cognitive behavioral therapy, mindfulness, and motivational interviewing [ 22 - 24 ].…”

“…That is, providers can easily refer patients to a digital resource because it is not limited by physical location or wait times, and patient challenges related to transportation, time, and fear of stigma are reduced and, in some cases, eliminated by enabling access to care without requiring travel to an in-person provider [ 12 , 13 ]. Furthermore, in a single-arm prospective pilot study, we demonstrated that delivery of a digital mental health intervention (Wysa) within an outpatient orthopedic care setting is feasible and preliminary effectiveness analyses are promising [ 14 ].…”