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The Impact of a Remote Digital Health Intervention for Anxiety And 1 The impact of a remote digital health intervention for anxiety and depression 2 on occupational and functional impairment: an observational, pre-post 3 intervention study 4 5 Marcos Economides, PhD a, Kristian Ranta MSc a, Outi Hilgert, MD a, 6 Dolores M. Kelleher, MS, DMHa,b, Patricia Arean, PhD c, Valerie L. Forman-Hoffman, PhD, 7 MPH a* 9 Author Note 10 a Meru Health Inc, San Mateo, CA, United States 11 b D Kelleher Consulting, Alameda, CA, United States 12 c Department of Psychiatry and Behavioral Sciences, University of Washington, Seattle, WA, 13 United States 15 This research did not receive any specific grant from funding agencies in the public, 16commercial, or not-for-profit sectors. 17 Correspondence concerning this article should be addressed to Valerie Hoffman. 18Contact: [email protected] 19 20 1 1 2 21Abstract 22Objectives 23The objective of this study was to assess whether the Meru Health Program (MHP), a novel, 24self-guided, structured smartphone-based intervention with asynchronous therapist 25support, is associated with improvements in occupational impairment and daily functioning 26in working adults with symptoms of depression and anxiety. 27Methods 28In this observational, pre-post study, occupational and functional impairment (assessed via 29the Workplace Performance and Activity Impairment [WPAI] questionnaire) was measured 30pre- and post-intervention in a real-world sample of employed patients (n = 64) receiving 31treatment via the MHP for symptoms of mild to moderate depression and/or anxiety 32(Patient Health Questionnaire-9 item scale [PHQ-9] > 4 and/or Generalized Anxiety Disorder- 337 item scale [GAD-7] > 4). 34Results 35The MHP was associated with improvements in presenteeism (mean decrease = 12.1, 95% 36CI = [4.17 – 20.0], p = 0.003; d = 0.56), overall work impairment (mean decrease = 13.4, 95% 37CI = [5.62 – 21.2], p < 0.001; d = 0.54), and impairment in daily functioning (mean decrease = 3814.8, 95% CI = [9.09 – 20.4], p < 0.001; d = 0.60), as well as smaller (non-significant) 39improvements in absenteeism (mean decrease = 4.32, 95% CI = [-1.00 to 9.64], p = 0.11; d = 400.25). A conservative estimate of annual productivity cost savings associated with the MHP 41is $6271 per employee, corresponding to a 30% relative improvement in overall work 42productivity. 43Conclusions 44Remote, smartphone-based interventions such as the MHP may help employees suffering 45with mild-to-moderate mental health issues function and perform better at work, resulting 46in cost savings for employers. 47 48 49 50Keywords: mhealth, digital therapeutics, depression, anxiety, productivity, absenteeism, 51presenteeism 3 2 4 52Introduction 53Depression and anxiety are both leading causes of disability and incur substantial costs 54associated with reduced work functioning, including absences, impaired productivity, and 55even decreased job retention worldwide [1-5]. A recent estimate across eight diverse 56countries suggests that depression in the workplace costs a collective $250 billion a year, 57and over $84 billion in the US alone [3]. Moreover, even minor or subthreshold symptoms of 58depression and anxiety have been shown to substantially decrease work performance [6-8]. 59Thus, there is an urgent need for cost-effective, evidence-based interventions that support 60employees with symptoms of depression and/or anxiety. Although effective treatments 61exist, interventions that can be delivered outside of normal working hours are urgently 62needed given the fact that working adults are particularly prone to citing time as a barrier to 63mental health care receipt. 64The advent of digital health technology has provided one such solution to counter these 65issues. Online and smartphone-based interventions for common mental health problems 66overcome access barriers to care [9,10] and have demonstrated clinical effectiveness 67comparable to face-to-face interventions [11-13]. However, the impact of such 68interventions remains primarily symptom-focused, with potential effects on work difficulties 69receiving considerably less attention. As a consequence, few studies have focused on the 70delivery and outcomes of these interventions to working adults, resulting in limited 71consensus regarding the effectiveness of both traditional treatment methods and newer 72digitally-delivered interventions in improving workplace outcomes such as productivity and 73attendance [14,15]. 74Previously, we described the design and feasibility of the Meru Health Program (MHP) – a 75scalable, smartphone-based, 8- to 12-week intervention, derived from several evidence- 76based treatments for depression and anxiety, such as mindfulness-based practices [16,17] 77and cognitive-behavioral therapy [18]. Individuals enrolled in the MHP complete weekly 78modules alongside an anonymous peer group (with whom they can interact) and have 79regular contact via messaging with a remote licensed therapist who monitors participant 80progress and offers support. Prior to and during the MHP, participants complete self- 81reported assessments of symptoms of depression and anxiety so that therapists can monitor 82their progress. 83Drawing from such data, we reported that the program is associated with clinically 84significant reductions in symptoms of depression and anxiety that persist for up to 12- 85months post-intervention [19,20]. The objective of this study was to assess whether 86completion of the MHP is also associated with improvements in occupational impairment 87and daily functioning (assessed via the Workplace Activity and Impairment Questionnaire 88[WPAI], included as a program outcome at a later date) in working adults with elevated 89symptoms of depression and/or anxiety. The WPAI, a long-standing and well-validated 90measure, produces four summary scores which in turn describe absenteeism, presenteeism, 91overall workplace impairment, and daily activity impairment. While the first three scores 92pertain to occupational functioning, the latter score pertains to day-to-day activities and 93thus does not require the respondent to be employed. Consistent with previous studies 94[3,7,21], we hypothesized that completion of the MHP would be associated with 5 3 6 95improvements in all four WPAI scores, and that the degree of improvement would be 96correlated with symptom change. 97Methods 98Study Design 99We used an observational, pre-post research design that included a single-arm pre- and 100post-intervention assessment of outcomes. Patient-reported outcomes were measured pre- 101intervention (“baseline”) and at the end of the MHP (“post-intervention”). 102Participants 103The present study included adult patients treated at the Meru Health online clinic (between 104March 2018 and May 2019), a national remote healthcare provider that currently operates 105in the United States and Finland. Participants, a majority of whom were female and from 106Finland, were either i) self-referrals, ii) referred by a healthcare provider, iii) enrolled via an 107employee wellness program, iv) or enrolled via a university health service (see Table 1). For 108inclusion, participants had to provide informed consent via the Meru Health app, own a 109smartphone, have at least mild symptoms of depression and/or anxiety (Patient Health 110Questionnaire-9 item scale [PHQ-9] score > 4 and/or Generalized Anxiety Disorder-7 item 111scale score [GAD-7] > 4 at baseline), and acknowledge/demonstrate the ability to commit to 112a minimum of 20 minutes of practice per day, for 6 days per week, across the intervention 113(as judged by both the participant and their assigned therapist). Exclusion criteria included a 114previous suicide attempt, severe active suicidal ideation with a specific plan, severe self- 115harm, active substance abuse, or a history of psychosis. 116 117Data were collected as part of the standard MHP. The PHQ-9 and GAD-7 were administered 118before, during, and after the program in the Meru Health app, while the WPAI was 119administered via an online form (hosted by www.typeform.com) external to the app. All 120procedures used were reviewed by Pearl IRB, who granted institutional review board 121exemption for analyses of previously collected and de-identified data, having been 122performed in accordance with the 1964 Helsinki declaration and its later amendments or 123comparable ethical standards. All participants provided informed consent for their 124anonymized data to be used for research purposes prior to participation. 125 126Sample size 127 128Since this study involved analysis of previously collected data, we did not plan to recruit a 129specific sample size. However, a post-hoc power calculation (using G*power 3.1; ANOVA: 130Repeated measures, within-factor [22]) based on a per protocol analysis (n = 64) and the 131effect sizes calculated in our analysis indicated we achieved >90% power for all outcomes 132apart from absenteeism where we achieved only 43% power. 133 134 135 7 4 8 136 137 Per Protocol All Participants Analysis (n = 139) (n = 64) Age (mean, SD) 36.4 (9.7) 36.9 (9.0) Gender Female (n, %) 105 (75.5) 53 (82.8) Male (n, %) 34 (24.5) 11 (17.2) Antidepressants Yes (n, %) 53 (38.1) 25 (39.1) No (n, %) 86 (61.9) 39 (60.9) Country Finland (n, %) 110 (79.1) 54 (84.4) US (n, %) 29 (20.9) 10 (15.6) Source Employee 43 (30.9) 25 (39.1) Wellness Program University Health 12 (8.6) 9 (14.1) System Self-referral 74 (53.2) 29 (45.3) Healthcare 10 (7.2) 1 (1.6) referral Intervention 8-week MHP 50 (36.0) 22 (34.4) 8-week MHP 48 (34.5) 20 (31.3) HRV-B 12-week MHP 41 (29.5) 22 (34.4) Baseline PHQ-9 13.0 (5.2) 11.9 (4.6) (mean, SD) Baseline GAD-7 10.7 (4.3) 10.6 (4.2) (mean, SD) 138GAD-7=Generalized Anxiety Disorder-7 item scale; MHP=Meru Health Program; 139PHQ=Patient Health Questionnaire-9 item scale; SD=standard deviation 140Table 1. Participant demographics and baseline symptom severity. 141 9 5 10 142Intervention 143The MHP has been described in detail previously [19,20]. Briefly, the original 8-week 144intervention includes daily content (typically 10-30 minutes) derived from evidence-based 145practices such as Mindfulness-Based Stress Reduction (MBSR) [17], Cognitive-Behavioral 146Therapy (CBT) [18], and Behavioral Activation Therapy (BAT) [23].
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