J Affect Disord 2018 Mar 15;229:443-449. Given the current environment with COVID-19, the ability to reach people in need with virtual care is critical. These are members who have completed a coaching or clinical session but received minimal therapeutic intervention based on their length of engagement. This time period was chosen because it reflects the approximate timing of when Ginger began to provide care to members via its employer business. Thus, formative evaluation can and should also occur in the form of a process evaluation alongside a summative evaluation such as an RCT. In our coaching-only analyses, we considered members who had exchanged at least 14 messages with a coach and created categories based on both the length and the frequency of their interaction (Textbox 1). Similarly, in the United States, anxiety disorders are the most common mental health condition, but a large portion of those affected (36.9%) are estimated to go untreated [5]. Coaching can continue supporting them in addressing day-to-day goals and challenges and act as an adjunct to the care plan put in place by their therapist or psychiatrist [23]. JFR was accepted for PubMed/PMC in November 2018. Psychometric properties and clinical utility of brief measures of depression, anxiety, and general distress: The PHQ-2, GAD-2, and K-6. While limited in several ways, this design has an important benefit in not being constrained by the strict requirements for controlled clinical trials. 5 2021: v.5(1) 2021 Jan: v.5(2) 2021 Feb: Vol. However, there are certain situations in which the duration of treatment is modified (either extended or shortened) based on member-specific circumstances (clinical presentation, covered sessions, the goodness of fit between clinician and member, and life circumstances), which is consistent with recommendations from the literature [17,32]. Additionally, we plan to explore how the different treatment modalities contribute to improved outcomes, digging into the “mechanism of action” to better understand how to replicate aspects of the platform that work well to support the larger rollout of these services to users. URL: Osenbach JE, O'Brien KM, Mishkind M, Smolenski DJ. It also suggests that more intensive forms of digital mental health services appear to contribute to greater improvement in outcomes, which is important for considering the scalability of these programs. It is important to note that a relatively small percentage of our study cohort was engaged in combined care, suggesting a need to promote this modality more broadly. Combined (coaching + clinical) utilization: In our clinical-only analyses, we created 4 categories based on the member’s number of sessions (Textbox 1). JMIR Research Protocols (ISSN 1929-0748) publishes peer-reviewed, openly accessible research ideas and grant proposals, study and trial protocols, reports of ongoing research, current methods and approaches. Human support reduces this commonly observed engagement problem but does not consistently improve clinical and recovery outcomes. The 14-message threshold is based on internal analyses of what constitutes a “typical” intake coaching session. Strengths of this study include the real-world setting and relatively large sample size, which allow us to observe varying levels of digital mental health support for anxiety among individuals seeking care for their mental concerns. 2020. Home Record. We considered 5 categories of members: (1) only accessed the Ginger app, (2) interacted with a coach or clinician but did not meet a minimum threshold for engagement, (3) only interacted with a behavioral health coach via text, (4) only interacted with a clinician (therapist or psychiatrist) via video, (5) interacted with both a behavioral health coach and clinician. Compared to the low-utilization group, there were significantly increased odds of improvement for the high utilization group but not for the low- and medium-utilization group. AN and PA are paid scientific advisors. [, Andrews G, Basu A, Cuijpers P, Craske M, McEvoy P, English C, et al. JMIR Dermatology (JDerm) is a new sister journal of JMIR (the leading open-access journal in health informatics), focusing on technologies, medical devices, apps, engineering, informatics applications for patient education in dermatology, including preventative interventions (e.g. In addition to demographics, Table 2 also reports care modality, levels of utilization, satisfaction scores, and clinical [Patient Health Questionnaire (PHQ) and GAD] intake scores for those who screened negative at follow-up and those who screened positive at follow-up. Among members who still screened positive at follow-up (855/1611, 53.1%), a total of 192 members (11.9%) experienced a clinically significant score reduction in the full GAD-7 (ie, a score reduction of ˃5 points), even though their GAD-2 scores were still positive. After adjusting for GAD-7 intake score, only the high utilization coefficient remained significant. EndNote Styles - JMIR Formative Research. Unfortunately, many mental health technology interventions suffer from high attrition rates, with users rapidly failing to maintain engagement with the intervention technology. Anxiety and Depression Household Pulse Survey. Compared to those who screened positive at follow-up, those who screened negative at follow-up (ie, “improved”) were significantly less likely to have only engaged with the app or have minimal care utilization. Ann Intern Med 2007 Mar 06;146(5):317-325. Centers for Disease Control and Prevention. This is a novel finding given the limited research focused on text-based coaching and this form of combined care. Can smartphone mental health interventions reduce symptoms of anxiety? Given their growing popularity, mobile health (mHealth) apps may offer a viable method of delivering psychological interventions for people with an atypical appearance (ie, visible difference) who struggle with appearance-related distress. 45 CFR 46. Women and girls are at greater risk of insomnia, yet differences in treatment responsiveness between genders have not been adequately investigated. This is also consistent with most evidence-based protocols of 8-12 sessions, as these sessions are not always completed at a weekly cadence [17]. Psychotherapy techniques include Cognitive Behavioral Therapy (CBT), which teaches people different ways of thinking, behaving, and reacting to anxiety-producing objects and situations. For example, we might consider looking more specifically and in greater depth at the frequency and intensity of coaching utilization and different patterns of coaching and clinical utilization (sequential vs concurrent). The COVID-19 pandemic hit the Netherlands at the end of February 2020, resulting in over 900,000 people testing positive for the virus, over 24,000 hospitalizations, and over 13,000 deaths by the end of January 2021. JRP mainly publishes proposals or protocols. In our coaching with clinical care (combined) analyses, we considered both a member’s coaching and clinical utilization level to calculate an overall utilization level. The Support Through Mobile Messaging and Digital Health Technology for Diabetes (SuMMiT-D) study aims to deliver brief messages as tailored interventions to support people with type 2 diabetes in better use of their diabetes medicines and to improve treatment adherence and health outcomes. Journal abbreviation: JMIR formative research. A positive screen was defined as a response score for either question of 2 or greater (ie, a response of “more than half the days” or “nearly every day”). [, Cohen AT, Goto S, Schreiber K, Torp-Pedersen C. Why do we need observational studies of everyday patients in the real-life setting? J Med Internet Res 2011 Aug 05;13(3):e52 [, Fuhr K, Schröder J, Berger T, Moritz S, Meyer B, Lutz W, et al. We also explore the association between levels of engagement within each care modality and odds of improvement in symptoms of anxiety. Guidance on defining the scope and development of text-based coaching protocols for digital mental health interventions. Longitudinal, natural experiments provide an ideal evaluation approach to better understand the impact of built environment interventions on community health outcomes, particularly health disparities. While many users are solely engaged with text-based coaching services, some will request or require escalation to clinical services (teletherapy or telepsychiatry), depending on preference or clinical severity. This is a retrospective observational study of individuals who accessed Ginger, an on-demand mental health system. Skip to main content. Naslund JA Association Between Care Utilization and Anxiety Outcomes in an On-Demand Mental Health System: Retrospective Observational Study JMIR Form Res 2021;5(1):e24662 doi: Examples of situations that require escalation include individuals with chronic mental illness and severe trauma, the potential to harm oneself or others, and significant mental instability (hallucinations, delusions, extreme mood swings, etc). Based on our inclusion criteria, 4369 individuals were eligible for this study. ISSN 2561-326X (Online) | JMIR formative research. U.S. Department of Health and Human Services. Future directions include more detailed classifications of utilization patterns and an exploration of explanations and solutions for lower-utilization members. This association remained after adjustment for baseline severity (GAD-7 intake score). Recovery rates in generalized anxiety disorder following psychological therapy: an analysis of clinically significant change in the STAI-T across outcome studies since 1990. Background: There is a persistent need for mental ill-health prevention and intervention among at-risk and vulnerable subpopulations. Thus, this study examines differences in anxiety outcomes by care modality (coaching, teletherapy and telepsychiatry, and combined care) within an on-demand mental health system. If we include the commonly accepted definition of a 5-point reduction in score, an additional 11.9% (192/1617) of the cohort would be classified as “improved.” Finally, we lack a control group to understand what would have happened in the absence of Ginger and to attribute causality, although we are able to understand these associations relative to defined reference groups. VA Center for Integrated Healthcare (CIH). To facilitate ongoing efforts to develop human support for digital mental health technologies, this paper describes the design decisions, theoretical framework, content, mode, timing of delivery, and the training and supervision for coaching support of the LiveWell technology. This support includes clearly defined and structured roles that aim to encourage the use of the technology, self-management strategies, and communication with care providers. Our first set of models assesses the association between care modality and improvement. In 2010, anxiety disorders were the sixth leading cause of disability in high-income and low- and middle-income countries [2]. We can build upon our understanding of these associations by increasing the collection of demographic data to enhance our understanding of member utilization patterns and user personas, and by adding content analysis of coaching messages. URL: Twenge J, Joiner T. Mental distress among U.S. adults during the COVID-19 pandemic. Neurocognitive disorders are often accompanied by behavioral symptoms such as anxiety, depression, and/or apathy. These symptoms can occur very early in the disease progression and are often difficult to detect and quantify in nonspecialized clinical settings. Insomnia and sleep disturbance are pervasive and debilitating conditions affecting up to 40% of adolescents. Nierenberg, John A 26.1.2021 Hospitalization for acute exacerbation of chronic obstructive pulmonary disease (COPD) is associated with poor prognosis. J Affect Disord 2020 Mar 15;265:395-401. [, Staples LG, Dear BF, Gandy M, Fogliati V, Fogliati R, Karin E, et al. <4 weeks of coaching, or the average days between interactions is ˃14 days, and <2 clinical sessions. Username or e-mail * Password * Forgot Password. Obviously, not all research designs or article types fit this format. Because there can be significant heterogeneity in these types of interventions, researchers and clinicians have published guidance on developing protocols for text-based coaching in digital mental health interventions [17]. Depress Anxiety 2013 Nov 06;30(11):1058-1067. April 02, 2021, Copyright © JMIR Medical Informatics (JMI, ISSN 2291-9694; Impact Factor: 2.58) (Editor-in-chief: Christian Lovis MD MPH FACMI) is a PubMed/SCIE-indexed journal that focuses on clinical informatics, big data in health and health care, decision support for health professionals, electronic health records, ehealth infrastructures and implementation.In June 2020, the journal received an impact factor of 2.58. 33496679 2020. A Hosmer-Lemeshow test failed to reject the null hypothesis, indicating goodness of fit, X2 (8, N=470)=7.11, P=.53. We planned to design an ACT-based mHealth intervention (ACT It Out) for this population. As there are many participant engagement challenges inherent in the design of large-scale community-based studies, adaptive and iterative participant engagement strategies are critical. Abstract: Background Cystic fibrosis (CF) is a rare, life-shortening, multiorgan disease, the treatment of which has seen significant increases in the life expectancy of those with CF. Community Health 2020 Apr 08;8(1):176-187. Abbreviation rules While the original focus was on the design of medical- and health-related research and technology innovations, JMIR Formative Research publishes studies from all areas of medical and health research. There are several limitations to this study. Diabetes is a highly prevalent long-term condition with high morbidity and mortality rates. 1 to 5; 2017 to 2021; Vol. ≥4 weeks of coaching, and average days between interactions is ≤14 days. 7872836, Copyright © URL: Tolles J, Meurer WJ. Future directions include more detailed classifications of utilization patterns and exploring explanations and solutions for lower utilization members. One of the gaps in our current knowledge relates to the long-term mental and physical impact of the infection on affected individuals. Leave this field blank . Ginger administers the survey every 2 weeks to users who screen positive and every 3 months for users who screen negative to monitor symptom response and assess if additional care is warranted. Objective: This study examines differences in anxiety outcomes by care modality (coaching, teletherapy and telepsychiatry, and combined care) within an on-demand mental health system. Published on Compared to the minimal-utilization reference group (those who only attended 1 therapy session), those in the low, medium, and high utilization categories had increased odds of improvement, with odds ratios increasing ordinally with each category. Table 3 reports the results of our primary model examining the association between care modality and anxiety symptom improvements. The app should support traditional contact tracing by faster tracing and greater reach compared to regular contact tracing procedures. Clinical Practice Guideline for the Treatment of Posttraumatic Stress Disorder: How Long Will It Take for Treatment to Work? Data were analyzed in Python and exported to spreadsheets for final analysis and review. The COVID-19 pandemic has only exacerbated growing concerns about the burden of anxiety due to the confluence of physical health risks, economic stressors, social isolation, and general disruption of daily activities [6]. For those users who had reported gender (560/1611, 34.5%), 371 (66.3%) were female and 187 (33.3%) were male. Finally, we calculated a total score (coach score + clinical score) to categorize combined coaching and clinical utilization (Textbox 1). Udall, Patricia We performed chi-square tests for categorical variables, t tests for continuous variables, and Mood median tests for medians to assess differences in characteristics between those who improved versus those who did not. JMIR Formative Research, Volume 5; doi:10.2196/24302 . Summative evaluations of programs and apps/software that have undergone a thorough formative evaluation before launch have a better chance to be published in high-impact flagship journals; thus, we encourage authors to submit - as a first step - their formative evaluations in JMIR Formative Research (and their evaluation protocols in JMIR Research Protocols). 1 (2021): Symptom improvement is assessed using the GAD-2. Our authors do not (or should not) publish in JMIR Res Protoc (JRP) to get "impact factor brownie points". We found no scientific literature on skills-based VR behavioral programs for chronic pain populations. Finally, 12 sessions is generally considered the upper limit for the recommended course of treatment, although sessions may be extended for serious and persistent mental illnesses that require ongoing and chronic medication management. Beyond teletherapy, there is also evidence that smartphone interventions can reduce anxiety symptoms [12]. A systematic review concluded that health coaching could motivate change in the lifestyle behavior of patients with chronic illness, leading to improvements in both physical and mental health status [15]. Patient Educ Couns 2014 Nov;97(2):147-157. JMIR Formative Research Vols. Validation and standardization of the Generalized Anxiety Disorder Screener (GAD-7) in the general population. Hunt J, Yip M, Survey completion is not required so as not to withhold support from members who decline to answer the questions but are still interested in accessing the Ginger services. This is due to the survey system design, which aims to avoid response burnout among users. They also tended to have higher levels of utilization within each modality and lower levels of anxiety at intake. Additionally, there is a promising observation that those engaged in combined care (teletherapy and text-based coaching) had the greatest odds of anxiety improvement. Table 4 reports outputs for the model examining the association between utilization and anxiety symptom improvement for the text-based coaching-only cohort. Little research has been performed on the majority of rare diseases. JMIR Formative Research publishes peer-reviewed, openly accessible papers containing results from process evaluations, feasibility/pilot studies and other kinds of formative research and preliminary results. All Clarivate Analytics websites use cookies to improve your online experience. Evidence for Health Decision Making — Beyond Randomized, Controlled Trials. These evidence-based treatments have been effectively delivered as telemedicine offerings, with several systematic reviews indicating that treatment delivered in this manner increases access and reach to care [10-12]. Study participants have access to the Ginger system as part of their employer or health plan benefits. We also had a relatively large amount of missing data for gender and age, which limited our ability to stratify analyses by key demographics. A Hosmer-Lemeshow test failed to reject the null hypothesis, indicating goodness of fit, X2 (8, N=349)=6.44, P=.50. In this study, we examined differences in anxiety outcomes by care modality—coaching, clinical (teletherapy and telepsychiatry), and combined (coaching and clinical) care—within an on-demand mental health system, as well as the association between levels of utilization within each care modality and improvement in anxiety symptoms. Digit Health 2019 Dec 16;5:2055207619896145 [, Frieden TR. JMIR Formative Research (JFR) (a sister journal of J Med Internet Res (JMIR) and JMIR mHealth & uHealth, the leading eHealth and mHealth journals by impact factor) publishes peer-reviewed, openly accessible papers containing results from process evaluations, feasibility/pilot studies and other kinds of formative research. Ξ, Dana Results: Of 1611 Ginger members, 761 (47.0%) experienced a decrease in anxiety symptoms, as measured by a change from a positive to a negative 2-item Generalized Anxiety Disorder (GAD-2) screen.