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://ichgcp.net/clinical-trials-registry/NCT04640090.

Keywords: anxiety; chronic pain; depression; digital health; health intervention; mental health; mobile phone; musculoskeletal; orthopedic; pain management.

Conflict of interest statement

Conflicts of Interest: None declared.

©Ashwin J Leo, Matthew J Schuelke, Devyani M Hunt, John P Metzler, J Philip Miller, Patricia A Areán, Melissa A Armbrecht, Abby L Cheng. Originally published in JMIR Formative Research (https://formative.jmir.org), 21.02.2022.

Figures

Figure 1

Screenshots of Wysa’s chronic pain version.

Figure 2

Participant flow, from initial study contact through final follow-up.

Figure 3

Mean longitudinal change in Patient-Reported Outcomes Measurement Information System (PROMIS) Depression scores over 2-month follow-up in patients who presented to an orthopedic clinic for a musculoskeletal condition, reported coexisting symptoms of depression and/or anxiety, and were high users (n=30, green circles) versus low users (n=31, blue triangles) of a digital mental health intervention (Wysa). Error bars represent standard errors.

Figure 4

Mean longitudinal change in Patient-Reported Outcomes Measurement Information System (PROMIS) Anxiety scores over 2-month follow-up in patients who presented to an orthopedic clinic for a musculoskeletal condition, reported coexisting symptoms of depression and/or anxiety, and were high users (n=30, green circles) versus low users (n=31, blue triangles) of a digital mental health intervention (Wysa). Error bars represent standard errors. Asterisk represents a statistically significant between-group difference in longitudinal score changes from baseline to 2-month follow-up (P<.05).

Figure 5

Mean longitudinal change in Patient-Reported Outcomes Measurement Information System (PROMIS) Pain Interference scores over 2-month follow-up in patients who presented to an orthopedic clinic for a musculoskeletal condition, reported coexisting symptoms of depression and/or anxiety, and were high users (n=30, green circles) versus low users (n=31, blue triangles) of a digital mental health intervention (Wysa). Error bars represent standard errors.

Figure 6

Mean longitudinal change in Patient-Reported Outcomes Measurement Information System (PROMIS) Physical Function scores over 2-month follow-up in patients who presented to an orthopedic clinic for a musculoskeletal condition, reported coexisting symptoms of depression and/or anxiety, and were high users (n=30, green circles) versus low users (n=31, blue triangles) of a digital mental health intervention (Wysa). Error bars represent standard errors..