Clinical Effects of Asynchronous Provider-Guided Practice Sessions During Blended Care Therapy for Anxiety and Depression: Pragmatic Retrospective Cohort Study.

BACKGROUND: Blended care therapy models are intended to increase the efficiency and effectiveness of evidence-based psychotherapy by combining synchronous and asynchronous components of care. OBJECTIVE: This retrospective cohort study evaluated the clinical effects of synchronous video therapy sessions and asynchronous guided practice session elements on anxiety and depression in a blended care therapy program, with a novel focus on asynchronous provider feedback messages. METHODS: Participants were adults (N=33,492) with clinical symptoms of anxiety (Generalized Anxiety Disorder 7-item scale [GAD-7] score of ≥8) and depression (Patient Health Questionnaire 9-item scale [PHQ-9] score of ≥10) at intake. Symptom trajectories were evaluated via individual growth curve models. Time-varying covariates evaluated effects of synchronous video session attendance and the presence or absence of each asynchronous guided practice session element occurring within 7 days and 8-14 days prior to each clinical outcome assessment. Guided practice session elements included client digital lesson completion, client digital exercise completion, and feedback messages sent by providers. RESULTS: Approximately 86.6% (29,012/33,492) of clients met criteria for clinical improvement by end of care (median 6, IQR 4-8 synchronous sessions). Synchronous video session attendance and client digital lesson completion in the past 7 days and in the past 8-14 days were each uniquely and significantly associated with lower GAD-7 scores (video session effects: bsession7=-0.82, bsession8-14=-0.58, P values<.001; digital lesson effects: blesson7=-0.18, blesson8-14=-0.26, P values <.001) and PHQ-9 scores (video session effects: bsession7=-0.89, bsession8-14=-0.67, P values <.001; digital lesson effects: blesson7=-0.12, blesson8-14=-0.30, P values <.001). Client digital exercise completion in the past 8-14 days was significantly associated with lower GAD-7 scores (bexercise8-14=-0.10; P<.001) but exercise completion in the 7 days prior to clinical outcome assessment was not (bexercise7=0.00; P=.89). Exercise completion in the past 7 days was significantly associated with lower PHQ-9 scores (bexercise7=-0.16; P<.001) but exercise completion in the past 8-14 days was not (bexercise8-14=-0.05; P=.09). Provider feedback messaging in the past 7 days and in the past 8-14 days was significantly associated with lower GAD-7 and PHQ-9 scores, respectively (GAD-7: bfeedback7=-0.12, P<.001; bfeedback8-14=-0.07, P=.004; PHQ-9: bfeedback7=-0.15, P<.001; bfeedback8-14=-0.08, P=.01). CONCLUSIONS: Provider feedback between synchronous therapy sessions provided significant benefit for symptom reduction, beyond the effects of client digital engagement and synchronous video sessions. When guided practice sessions are well integrated into care, blended care therapy provides meaningful improvements upon the traditional, synchronous session-only therapy model. Provider guidance and feedback for clients between synchronous sessions support more efficient and effective mental health care overall.

Telemental Health Collaborative Care Medication Management: Implementation and Outcomes.

Introduction: Access to quality mental health medication management (MM) in the United States is limited, even among those with employment-based health insurance. This implementation, feasibility, and outcome study sought to design and evaluate an evidence-based telemental health MM service using a collaborative care model (CoCM). Materials and Methods: CoCM MM was available to adult employees/dependents through their employer benefits, in addition to therapy. Outcomes included Patient Health Questionnaire-9 (PHQ-9) and the Generalized Anxiety Disorder-7 (GAD-7) collected at baseline and throughout participation. This analysis was not deemed to be human subjects research by the Western Institutional Review Board. Results: Over 17 months, 212 people enrolled and completed >2 assessments; the enrollees were 58.96% female with average age of 32.00 years (standard deviation [SD] = 7.38). In people with moderate to severe depression or anxiety, PHQ-9 and GAD-7 scores reduced by an average of 7.27 (SD = 4.80) and 6.71 (SD = 5.18) points after at least 12 ± 4 weeks in the program. At 24 ± 4 weeks, the PHQ-9 and GAD-7 reductions were on average 7.17 (SD = 5.00) and 6.03 (SD = 5.37), respectively. Approximately 65.88% of participants with either baseline depression or anxiety had a response on either the PHQ-9 or GAD-7 at 12 ± 4 weeks and 44.71% of participants experienced remission; at 24 ± 4 weeks, 56.41% had response and 41.03% experienced remission. Conclusions: An evidence-based CoCM telemedicine service within an employee behavioral health benefit is feasible and effective in reducing anxiety and depression symptoms when using measurement-based care. Widespread implementation of a benefit like this could expand access to evidence-based mental health MM.

Effectiveness of a Cognitive Behavioral Coaching Program Delivered via Video in Real World Settings.

Background: Many employees experience high levels of stress in the workplace, which negatively impact their productivity and well-being. Effective stress management interventions exist, but are inaccessible due to insufficient numbers of mental health providers, long waiting times to initiate care, high out-of-pocket cost of care, and stigma related to receiving psychotherapy. Introduction: The purpose of this study was to test the efficacy, in real-world circumstances, of a structured, cognitive behavioral coaching (CBC) program delivered through video or telephone. Materials and Methods: Retrospective data on 289 subjects who had sought support for emotional health through a behavioral health benefit offered through employers were examined. Changes in perceived stress and well-being over the course of the program were measured using the Perceived Stress Scale (PSS) and Warwick-Edinburgh Mental Well-being Scale (WEMWBS), respectively. Rates of reliable change and satisfaction with the coaching program were also assessed. Results: Scores on both the PSS and WEMWBS improved between baseline and follow-up. Approximately 61.9% (n = 289) of participants demonstrated reliable improvement on either measure. Discussion: CBC is a promising intervention that has the potential to significantly expand access to effective and more affordable interventions for emotional health care. Conclusions: Coaching, when delivered by accredited professionals trained in cognitive behavioral theory and interventions and working in real-world settings, can be efficacious in decreasing perceived stress and increasing well-being when delivered through video or telephone.

Blended Care-Cognitive Behavioral Therapy for Depression and Anxiety in Real-World Settings: Pragmatic Retrospective Study.

BACKGROUND: The past few decades saw considerable advances in research and dissemination of evidence-based psychotherapies, yet available treatment resources are not able to meet the high need for care for individuals suffering from depression or anxiety. Blended care psychotherapy, which combines the strengths of therapist-led and internet interventions, can narrow this gap and be clinically effective and efficient, but has rarely been evaluated outside of controlled research settings. OBJECTIVE: This study evaluated the effectiveness of a blended care intervention (video-based cognitive behavior therapy and internet intervention) under real-world conditions. METHODS: This is a pragmatic retrospective cohort analysis of 385 participants with clinical range depression and/or anxiety symptoms at baseline, measured using Patient Health Questionnaire-9 (PHQ-9) and Generalized Anxiety Disorder-7 (GAD-7), who enrolled in blended care psychotherapy treatment. Participants resided in the United States and had access to the blended care intervention as a mental health benefit offered through their employers. Levels of depression and anxiety were tracked throughout treatment. Hierarchical linear modeling was used to examine the change in symptoms over time. The effects of age, gender, and providers on participants' symptom change trajectories were also evaluated. Paired sample t-tests were also conducted, and rates of positive clinical change and clinically significant improvement were calculated. RESULTS: The average depression and anxiety symptoms at 6 weeks after the start of treatment were 5.94 and 6.57, respectively. There were significant linear effects of time on both symptoms of depression and anxiety (ß=-.49, P<.001 and ß=-.64, P<.001). The quadratic effect was also significant for both symptoms of depression and anxiety (ß=.04, P<.001 for both), suggesting a decelerated decrease in symptoms over time. Approximately 73% (n=283) of all 385 participants demonstrated reliable improvement, and 83% (n=319) recovered on either the PHQ-9 or GAD-7 measures. Large effect sizes were observed on both symptoms of depression (Cohen d=1.08) and of anxiety (d=1.33). CONCLUSIONS: Video blended care cognitive behavioral therapy interventions can be effective and efficient in treating symptoms of depression and anxiety in real-world conditions. Future research should investigate the differential and interactive contribution of the therapist-led and digital components of care to patient outcomes to optimize care.

Walk-in clinics versus physician offices and emergency rooms for urgent care and chronic disease management.

BACKGROUND: Walk-in clinics are growing in popularity around the world as a substitute for traditional medical care delivered in physician offices and emergency rooms, but their clinical efficacy is unclear. OBJECTIVES: To assess the quality of care and patient satisfaction of walk-in clinics compared to that of traditional physician offices and emergency rooms for people who present with basic medical complaints for either acute or chronic issues. SEARCH METHODS: We searched CENTRAL, MEDLINE, Embase, six other databases, and two trials registers on 22 March 2016 together with reference checking, citation searching, and contact with study authors to identify additional studies. We applied no restrictions on language, publication type, or publication year. SELECTION CRITERIA: Study design: randomized trials, non-randomized trials, and controlled before-after studies. POPULATION: standalone physical clinics not requiring advance appointments or registration, that provided basic medical care without expectation of follow-up. Comparisons: traditional primary care practices or emergency rooms. DATA COLLECTION AND ANALYSIS: We used standard methodological procedures expected by Cochrane and the Cochrane Effective Practice and Organisation of Care (EPOC) Group. MAIN RESULTS: The literature search identified 6587 citations, of which we considered 65 to be potentially relevant. We reviewed the abstracts of all 65 potentially relevant studies and retrieved the full texts of 12 articles thought to fit our study criteria. However, following independent author assessment of the full texts, we excluded all 12 articles. AUTHORS' CONCLUSIONS: Controlled trial evidence about the mortality, morbidity, quality of care, and patient satisfaction of walk-in clinics is currently not available.

The Impact of a Workforce Mental Health Program on Employer Medical Plan Spend: An Application of Cost Efficiency Measurement for Mental Health Care.

Mental health issues often result in significant impairment and financial challenges, both at home and in the workplace. Solutions vary widely in their usage and cost-effectiveness. This study presents an analysis of medical and prescription drug spending and utilization data for the employees of 4 companies who were eligible for an evidence-based workforce mental health program (WMHP). A variation of coarsened exact matching paired WMHP users to nonusers, based on demographics, location, and medical factors. Individuals included 2791 pairs of members whose medical claims were incurred in 2018 and 3883 pairs with claims in 2019. Using a cost efficiency measurement process, mean cost and utilization per person per year (PPPY) were compared. WMHP users had lower medical (-$2295 in 2018; -$2304 in 2019) and prescription drug spending (-$295 in 2018; -$312 in 2019). Over half of the cost reduction (-$1252 in 2018; -$1211 in 2019) resulted from shifting therapy services from the medical benefit to WMHP. WMHP users attended about 12 sessions PPPY, whereas the comparison group of nonusers attended about 7 mental health office visits PPPY under the medical benefit. WMHP users had more mental health-related visits in both years, but had fewer visits on the medical plan, and fewer emergency department visits for mental health than comparison group members. These results provide evidence that high-quality, evidence-based mental health services can reduce total expenditures and change utilization patterns. Evidence-based WMHP may represent a prudent investment for employers in providing mental health care to employees.

Component analysis of a synchronous and asynchronous blended care CBT intervention for symptoms of depression and anxiety: Pragmatic retrospective study.

Background: Depression and anxiety are leading causes of disability worldwide. Though effective treatments exist, depression and anxiety remain undertreated. Blended care psychotherapy, combining the scalability of online interventions with the personalization and engagement of a live therapist, is a promising approach for increasing access to evidence-based care. Objectives: To evaluate the effectiveness and individual contribution of two components - i) digital tools and ii) video-based therapist-led sessions - in a blended care CBT-based intervention under real world conditions. Methods: A retrospective cohort design was used to analyze N = 1372 US-based individuals who enrolled in blended care psychotherapy. Of these, at baseline, 761 participants had depression symptoms in the clinical range (based on PHQ-9), and 1254 had anxiety symptoms in the clinical range (based on GAD-7). Participants had access to the program as a mental health benefit offered by their employer. The CBT-based blended care psychotherapy program consisted of regular video sessions with therapists, complemented by digital lessons and digital exercises assigned by the clinician and completed in between sessions. Depression and anxiety levels and clients' treatment engagement were tracked throughout treatment. A 3-level individual growth curve model incorporating time-varying covariates was utilized to examine symptom trajectories of PHQ-9 scores (for those with clinical range of depression at baseline) and GAD-7 scores (for those with clinical range of anxiety at baseline). Results: On average, individuals exhibited a significant decline in depression and anxiety symptoms during the initial weeks of treatment (P < .001), and a continued decline over subsequent weeks at a slower rate (P < .001). Engaging in a therapy session in a week was associated with lower GAD-7 (b = -0.81) and PHQ-9 (b = -1.01) scores in the same week, as well as lower GAD-7 (b = -0.58) and PHQ-9 (b = -0.58) scores the following week (all P < .01). Similarly, engaging with digital lessons was independently associated with lower GAD-7 (b = -0.19) and PHQ-9 (b = -0.18) scores during the same week, and lower GAD-7 (b = -0.25) and PHQ-9 (b = -0.27) the following week (all P < .01). Conclusions: Therapist-led video sessions and digital lessons had separate contributions to improvements in symptoms of depression and anxiety over the course of treatment. Future research should investigate whether clients' characteristics are related to differential effects of therapist-led and digital components of care.

Academic Medical Centers as digital health catalysts.

Emerging digital technologies offer enormous potential to improve quality, reduce cost, and increase patient-centeredness in healthcare. Academic Medical Centers (AMCs) play a key role in advancing medical care through cutting-edge medical research, yet traditional models for invention, validation and commercialization at AMCs have been designed around biomedical initiatives, and are less well suited for new digital health technologies. Recently, two large bi-coastal Academic Medical Centers, the University of California, San Francisco (UCSF) through the Center for Digital Health Innovation (CDHI) and Partners Healthcare through the Center for Connected Health (CCH) have launched centers focused on digital health innovation. These centers show great promise but are also subject to significant financial, organizational, and visionary challenges. We explore these AMC initiatives, which share the following characteristics: a focus on academic research methodology; integration of digital technology in educational programming; evolving models to support "clinician innovators"; strategic academic-industry collaboration and emergence of novel revenue models.

Inclusion of training patients in US Food and Drug Administration premarket approval cardiovascular device studies.

BACKGROUND: Training patients are the first individuals in whom a physician uses an investigational device. There is great variability in the use of data from training patients in the absence of guidelines. The prevalence and extent of data reporting from training patients in cardiovascular device studies submitted for US Food and Drug Administration (FDA) approval has not been characterized. METHODS: Information on training patients was abstracted from the Summary of Safety and Effectiveness Data summarizing cardiovascular device premarket applications approved by the FDA from 2000 through 2007. We examined the numbers and characteristics of training patients and the inclusion of their results in end-point analyses. RESULTS: There were 78 cardiovascular device summaries in this 8-year period, of which 17 (22%) involved training patients. Of the 123 studies in the summaries, 20 (16%) used training patients. All studies excluded training patients from efficacy analyses and 19 of 20 (95%) excluded them from safety analyses. Sixteen of 20 (80%) did not provide any outcome data, and 15 of 20 (75%) did not check for outcome differences between training and nontraining treatment patients. Eighteen of 20 (90%) did not provide demographic information on training patients, and 14 of 20 (70%) did not prespecify guidelines for their enrollment. CONCLUSIONS: Training patients comprise a considerable proportion of patients receiving investigational cardiovascular devices, but their results are excluded from FDA submissions. Their exclusion from analyses means that safety and efficacy outcomes may look better than actual results. Guidelines on the use and inclusion of results for training patients would improve accuracy on results reporting.