Relationship Between Diabetes, Stress, and Self-Management to Inform Chronic Disease Product Development: Retrospective Cross-Sectional Study.

BACKGROUND: Technology is rapidly advancing our understanding of how people with diabetes mellitus experience stress. OBJECTIVE: The aim of this study was to explore the relationship between stress and sequelae of diabetes mellitus within a unique data set composed of adults enrolled in a digital diabetes management program, Livongo, in order to inform intervention and product development. METHODS: Participants included 3263 adults under age 65 who were diagnosed with diabetes mellitus and had access to Livongo through their employer between June 2015 and August 2018. Data were collected at time of enrollment and 12 months thereafter, which included demographic information, glycemic control, presence of stress, diabetes distress, diabetes empowerment, behavioral health diagnosis, and utilization of behavioral health-related medication and services. Analysis of variance and chi-square tests compared variables across groups that were based on presence of stress and behavioral health diagnosis or utilization. RESULTS: Fifty-five percent of participants (1808/3263) reported stress at the time of at least 1 blood glucose reading. Fifty-two percent of participants (940/1808) also received at least 1 behavioral health diagnosis or intervention. Compared to their peers, participants with stress reported greater diabetes distress, lower diabetes empowerment, greater insulin use, and poorer glycemic control. Participants with stress and a behavioral health diagnosis/utilization additionally had higher body mass index and duration of illness. CONCLUSIONS: Stress among people with diabetes mellitus is associated with reduced emotional and physical health. Digital products that focus on the whole person by offering both diabetes mellitus self-management tools and behavioral health skills and support can help improve disease-specific and psychosocial outcomes.

Advances in PTSD Treatment Delivery: Review of Findings and Clinical Considerations for the Use of Telehealth Interventions for PTSD.

PURPOSE OF REVIEW: Effective treatments for posttraumatic stress disorder (PTSD) remain underutilized and individuals with PTSD often have difficulty accessing care. Telehealth, particularly clinical videoconferencing (CVT), can overcome barriers to treatment and increase access to care for individuals with PTSD. The purpose of this review is to summarize the literature on the delivery of PTSD treatments through office-based and home-based videoconferencing, and outline areas for future research. RECENT FINDINGS: Evidence-based PTSD treatments delivered through office-based and home-based CVT have been studied in pilot studies, non-randomized trials, and randomized clinical trials. The studies have consistently demonstrated feasibility and acceptability of these modalities as well as significant reduction in PTSD symptoms, non-inferior outcomes, and comparable dropout rates when compared with traditional face-to-face office-based care. Finally, it has been shown that using CVT does not compromise the therapeutic process. SUMMARY: Office-based and home-based CVT can be used to deliver PTSD treatments while retaining efficacy and therapeutic process. The use of these modalities can increase the number of individuals that can access efficacious PTSD care.

VA mobile apps for PTSD and related problems: public health resources for veterans and those who care for them.

Many public health agencies, including the U.S. Department of Veterans Affairs (VA), have identified the use of mobile technologies as an essential part of a larger strategy to address major public health challenges. The VA's National Center for PTSD (NCPTSD), in collaboration with VA's Office of Mental Health and Suicide Prevention and the Defense Health Agency inside the U.S. Department of Defense (DoD), has been involved in the development, evaluation, and testing of 15 mobile apps designed specifically to address the needs and concerns of veterans and others experiencing symptoms of posttraumatic stress disorder (PTSD). These applications include seven treatment-companion apps (designed to be used with a provider, in conjunction with an evidence-based therapy) and eight self-management apps (designed to be used independently or as an adjunct or extender of traditional care). There is growing evidence for the efficacy of several of these apps for reducing PTSD and other symptoms, and studies of providers demonstrate that the apps are engaging, easy-to-use, and provide a relative advantage to traditional care without apps. While publicly available apps do not collect or share personal data, VA has created research-enabled versions of many of its mental health apps to enable ongoing product enhancement and continuous measurement of the value of these tools to veterans and frontline providers. VA and DoD are also collaborating on provider-based implementation networks to enable clinicians to optimize implementation of mobile technologies in care. Although there are many challenges to developing and integrating mHealth into care, including cost, privacy, and the need for additional research, mobile mental health technologies are likely here to stay and have the potential to reach large numbers of those with unmet mental health needs, including PTSD-related concerns.

PTSD Coach around the world.

Posttraumatic stress disorder (PTSD) is a global public health problem. Unfortunately, many individuals with PTSD do not receive professional care due to a lack of available providers, stigma about mental illness, and other concerns. Technology-based interventions, including mobile phone applications (apps) may be a viable means of surmounting such barriers and reaching and helping those in need. Given this potential, in 2011 the U.S Veterans Affairs National Center for PTSD released PTSD Coach, a mobile app intended to provide psycho-education and self-management tools for trauma survivors with PTSD symptoms. Emerging research on PTSD Coach demonstrates high user satisfaction, feasibility, and improvement in PTSD symptoms and other psychosocial outcomes. A model of openly sharing the app's source code and content has resulted in versions being created by individuals in six other countries: Australia, Canada, The Netherlands, Germany, Sweden, and Denmark. These versions are described, highlighting their significant adaptations, enhancements, and expansions to the original PTSD Coach app as well as emerging research on them. It is clear that the sharing of app source code and content has benefited this emerging PTSD Coach community, as well as the populations they are targeting. Despite this success, challenges remain especially reaching trauma survivors in areas where few or no other mental health resources exist.

Expert Consensus Survey on Digital Health Tools for Patients With Serious Mental Illness: Optimizing for User Characteristics and User Support.

BACKGROUND: Digital technology is increasingly being used to enhance health care in various areas of medicine. In the area of serious mental illness, it is important to understand the special characteristics of target users that may influence motivation and competence to use digital health tools, as well as the resources and training necessary for these patients to facilitate the use of this technology. OBJECTIVE: The aim of this study was to conduct a quantitative expert consensus survey to identify key characteristics of target users (patients and health care professionals), barriers and facilitators for appropriate use, and resources needed to optimize the use of digital health tools in patients with serious mental illness. METHODS: A panel of 40 experts in digital behavioral health who met the participation criteria completed a 19-question survey, rating predefined responses on a 9-point Likert scale. Consensus was determined using a chi-square test of score distributions across three ranges (1-3, 4-6, 7-9). Categorical ratings of first, second, or third line were designated based on the lowest category into which the CI of the mean ratings fell, with a boundary >6.5 for first line. Here, we report experts' responses to nine questions (265 options) that focused on (1) user characteristics that would promote or hinder the use of digital health tools, (2) potential benefits or motivators and barriers or unintended consequences of digital health tool use, and (3) support and training for patients and health care professionals. RESULTS: Among patient characteristics most likely to promote use of digital health tools, experts endorsed interest in using state-of-the-art technology, availability of necessary resources, good occupational functioning, and perception of the tool as beneficial. Certain disease-associated signs and symptoms (eg, more severe symptoms, substance abuse problems, and a chaotic living situation) were considered likely to make it difficult for patients to use digital health tools. Enthusiasm among health care professionals for digital health tools and availability of staff and equipment to support their use were identified as variables to enable health care professionals to successfully incorporate digital health tools into their practices. The experts identified a number of potential benefits of and barriers to use of digital health tools by patients and health care professionals. Experts agreed that both health care professionals and patients would need to be trained in the use of these new technologies. CONCLUSIONS: These results provide guidance to the mental health field on how to optimize the development and deployment of digital health tools for patients with serious mental illness.

A randomized controlled pilot study of CBT-I Coach: Feasibility, acceptability, and potential impact of a mobile phone application for patients in cognitive behavioral therapy for insomnia.

There has been growing interest in utilizing mobile phone applications (apps) to enhance traditional psychotherapy. Previous research has suggested that apps may facilitate patients' completion of cognitive behavioral therapy for insomnia (CBT-I) tasks and potentially increase adherence. This randomized clinical trial pilot study ( n = 18) sought to examine the feasibility, acceptability, and potential impact on adherence and sleep outcomes related to CBT-I Coach use. All participants were engaged in CBT-I, with one group receiving the app as a supplement and one non-app group. We found that patients consistently used the app as intended, particularly the sleep diary and reminder functions. They reported that it was highly acceptable to use. Importantly, the app did not compromise or undermine benefits of cognitive behavioral therapy for insomnia and patients in both groups had significantly improved sleep outcomes following treatment.

A randomized controlled trial of a smartphone app for posttraumatic stress disorder symptoms.

OBJECTIVE: Posttraumatic stress disorder (PTSD) is highly prevalent in the population, but relatively few affected individuals receive treatment for it. Smartphone applications (apps) could help address this unmet need by offering sound psychoeducational information and evidence-based cognitive behavioral coping tools. We conducted a randomized controlled trial to assess the efficacy of a free, publicly available smartphone app (PTSD Coach) for self-management of PTSD symptoms. METHOD: One hundred 20 participants who were an average of 39 years old, mostly women (69.2%) and White (66.7%), recruited primarily through online advertisements, were randomized to either a PTSD Coach (n = 62) or a waitlist condition (n = 58) for 3 months. Web-administered self-report measures of PTSD, PTSD symptom coping self-efficacy, depression, and psychosocial functioning were conducted at baseline, posttreatment, and 3 months following treatment. RESULTS: Following the intent-to-treat principle, repeated-measures analyses of variance (ANOVAs) revealed that at posttreatment, PTSD Coach participants had significantly greater improvements in PTSD symptoms (p = .035), depression symptoms (p = .005), and psychosocial functioning (p = .007) than did waitlist participants; however, at posttreatment, there were no significant mean differences in outcomes between conditions. A greater proportion of PTSD Coach participants achieved clinically significant PTSD symptom improvement (p = .018) than waitlist participants. CONCLUSION: PTSD Coach use resulted in significantly greater improvements in PTSD symptoms and other outcomes relative to a waitlist condition. Given the ubiquity of smartphones, PTSD Coach may provide a wide-reaching, convenient public health intervention for individuals with PTSD symptoms who are not receiving care. (PsycINFO Database Record

Development and refinement of a clinician intervention to facilitate primary care patient use of the PTSD Coach app.

Posttraumatic stress disorder (PTSD) is common and undertreated among Veterans Affairs (VA) primary care patients. A brief primary care intervention combining clinician support with a self-management mobile app (Clinician-Supported PTSD Coach, CS-PTSD Coach) may improve patient outcomes. This study developed and refined an intervention to provide clinician support to facilitate use of the PTSD Coach app and gathered VA provider and patient qualitative and quantitative feedback on CS-PTSD Coach to investigate preliminary acceptability and implementation barriers/facilitators. VA primary care providers and mental health leadership (N = 9) completed a survey and interview regarding implementation barriers and facilitators structured according to the Consolidated Framework for Implementation Research (CFIR). Clinicians who delivered CS-PTSD Coach (N = 3) and patients (N = 9) who received it provided feedback on the intervention and implementation process. CS-PTSD Coach has high provider and patient acceptability. Important implementation factors included that CS-PTSD Coach be compatible with the clinics' current practices, have low complexity to implement, be perceived to address patient needs, and have strong support from leadership. Diverse factors related to CS-PTSD Coach delivery facilitate implementation, provide an opportunity to problem-solve barriers, and improve integration of the intervention into primary care.

Feasibility, acceptability, and potential efficacy of the PTSD Coach app: A pilot randomized controlled trial with community trauma survivors.

OBJECTIVE: Posttraumatic stress disorder (PTSD) is a major public health concern. Although effective treatments exist, affected individuals face many barriers to receiving traditional care. Smartphones are carried by nearly 2 thirds of the U.S. population, offering a promising new option to overcome many of these barriers by delivering self-help interventions through applications (apps). As there is limited research on apps for trauma survivors with PTSD symptoms, we conducted a pilot feasibility, acceptability, and potential efficacy trial of PTSD Coach, a self-management smartphone app for PTSD. METHOD: A community sample of trauma survivors with PTSD symptoms (N = 49) were randomized to 1 month using PTSD Coach or a waitlist condition. Self-report assessments were completed at baseline, postcondition, and 1-month follow-up. Following the postcondition assessment, waitlist participants were crossed-over to receive PTSD Coach. RESULTS: Participants reported using the app several times per week, throughout the day across multiple contexts, and endorsed few barriers to use. Participants also reported that PTSD Coach components were moderately helpful and that they had learned tools and skills from the app to manage their symptoms. Between conditions effect size estimates were modest (d = -0.25 to -0.33) for PTSD symptom improvement, but not statistically significant. CONCLUSIONS: Findings suggest that PTSD Coach is a feasible and acceptable intervention. Findings regarding efficacy are less clear as the study suffered from low statistical power; however, effect size estimates, patterns of within group findings, and secondary analyses suggest that further development and research on PTSD Coach is warranted. (PsycINFO Database Record

CBT-I Coach: A Description and Clinician Perceptions of a Mobile App for Cognitive Behavioral Therapy for Insomnia.

STUDY OBJECTIVES: This paper describes CBT-I Coach, a patient-facing smartphone app designed to enhance cognitive behavioral therapy for insomnia (CBT-I). It presents findings of two surveys of U.S. Department of Veterans Affairs (VA) CBT-I trained clinicians regarding their perceptions of CBT-I Coach before it was released (n = 138) and use of it two years after it was released (n = 176). METHODS: VA-trained CBT-I clinicians completed web-based surveys before and two years after CBT-I Coach was publicly released. RESULTS: Prior to CBT-I Coach release, clinicians reported that it was moderately to very likely that the app could improve care and a majority (87.0%) intended to use it if it were available. Intention to use the app was predicted by smartphone ownership (ß = 0.116, p < 0.05) and perceptions of relative advantage to existing CBT-I practices (ß = 0.286, p < 0.01), compatibility with their own needs and values (ß = 0.307, p < 0.01), and expectations about the complexity of the app (ß = 0.245, p < 0.05). Two years after CBT-I Coach became available, 59.9% of participants reported using it with patients and had favorable impressions of its impact on homework adherence and outcomes. CONCLUSIONS: Findings suggest that before release, CBT-I Coach was perceived to have potential to enhance CBT-I and address common adherence issues and clinicians would use it. These results are reinforced by findings two years after it was released suggesting robust uptake and favorable perceptions of its value.

Using PTSD Coach in primary care with and without clinician support: a pilot randomized controlled trial.

OBJECTIVE: This study aims to evaluate the feasibility and potential effectiveness of two approaches to using the PTSD Coach mobile application in primary care: Self-Managed PTSD Coach and Clinician-Supported PTSD Coach. This study also aims to gather preliminary data to investigate if clinician support improves the benefits of using PTSD Coach on posttraumatic stress disorder (PTSD) severity and specialty mental healthcare utilization. METHOD: Twenty primary care veterans with PTSD symptoms were randomized to either Self-Managed PTSD Coach consisting of one 10-min session providing instructions for application use or Clinician-Supported PTSD Coach consisting of four 20-min sessions focused on setting symptom reduction goals and helping veterans fully engage with application content. RESULTS: Research procedures and intervention conditions appear feasible as indicated by high rates of assessment and intervention retention and high clinician fidelity and satisfaction. Both treatments resulted in reductions in PTSD symptoms, with 7 Clinician-Supported PTSD Coach and 3 Self-Managed PTSD Coach participants reporting clinically significant improvements. Clinician-Supported PTSD Coach resulted in more specialty PTSD care use postintervention and possibly greater reductions in PTSD symptoms. CONCLUSIONS: Both PTSD Coach interventions are feasible and potentially helpful. The addition of clinician support appears to increase the effectiveness of self-management alone. A larger-scale randomized controlled trial is warranted to confirm these encouraging preliminary findings.

mHealth in the Wild: Using Novel Data to Examine the Reach, Use, and Impact of PTSD Coach.

BACKGROUND: A majority of Americans (58%) now use smartphones, making it possible for mobile mental health apps to reach large numbers of those who are living with untreated, or under-treated, mental health symptoms. Although early trials suggest positive effects for mobile health (mHealth) interventions, little is known about the potential public health impact of mobile mental health apps. OBJECTIVE: The purpose of this study was to characterize reach, use, and impact of "PTSD Coach", a free, broadly disseminated mental health app for managing posttraumatic stress disorder (PTSD) symptoms. METHODS: Using a mixed-methods approach, aggregate mobile analytics data from 153,834 downloads of PTSD Coach were analyzed in conjunction with 156 user reviews. RESULTS: Over 60% of users engaged with PTSD Coach on multiple occasions (mean=6.3 sessions). User reviews reflected gratitude for the availability of the app and being able to use the app specifically during moments of need. PTSD Coach users reported relatively high levels of trauma symptoms (mean PTSD Checklist Score=57.2, SD=15.7). For users who chose to use a symptom management tool, distress declined significantly for both first-time users (mean=1.6 points, SD=2.6 on the 10-point distress thermometer) and return-visit users (mean=2.0, SD=2.3). Analysis of app session data identified common points of attrition, with only 80% of first-time users reaching the app's home screen and 37% accessing one of the app's primary content areas. CONCLUSIONS: These findings suggest that PTSD Coach has achieved substantial and sustained reach in the population, is being used as intended, and has been favorably received. PTSD Coach is a unique platform for the delivery of mobile mental health education and treatment, and continuing evaluation and improvement of the app could further strengthen its public health impact.

Comparison of the PTSD Checklist (PCL) Administered via a Mobile Device Relative to a Paper Form.

Mobile devices are increasingly used to administer self-report measures of mental health symptoms. There are significant differences, however, in the way that information is presented on mobile devices compared to the traditional paper forms that were used to administer such measures. Such differences may systematically alter responses. The present study evaluated if and how responses differed for a self-report measure, the PTSD Checklist (PCL), administered via mobile device relative to paper and pencil. Participants were 153 trauma-exposed individuals who completed counterbalanced administrations of the PCL on a mobile device and on paper. PCL total scores (d = 0.07) and item responses did not meaningfully or significantly differ across administrations. Power was sufficient to detect a difference in total score between administrations determined by prior work of 3.46 with a d = 0.23. The magnitude of differences between administration formats was unrelated to prior use of mobile devices or participant age. These findings suggest that responses to self-report measures administered via mobile device are equivalent to those obtained via paper and they can be used with experienced as well as naïve users of mobile devices.

A Virtual Hope Box smartphone app as an accessory to therapy: proof-of-concept in a clinical sample of veterans.

A "Hope Box" is a therapeutic tool employed by clinicians with patients who are having difficulty coping with negative thoughts and stress, including patients who may be at risk of suicide or nonsuicidal self-harm. We conducted a proof-of-concept test of a "Virtual" Hope Box (VHB)-a smartphone app that delivers patient-tailored coping tools. Compared with a conventional hope box integrated into VA behavioral health treatment, high-risk patients and their clinicians used the VHB more regularly and found the VHB beneficial, useful, easy to set up, and said they were likely to use the VHB in the future and recommend the VHB to peers.

Clinician perceptions of using a smartphone app with prolonged exposure therapy.

Clinician perceptions of clinical innovations affect their adoption and spread. This study investigated mental health clinicians' (n = 163) perceptions of a patient-facing smartphone application (app) for prolonged exposure (PE) therapy for posttraumatic stress disorder, before its public release. After reading a description of the app, participants rated perceptions of it based on diffusion of innovations theory constructs. Perceptions were generally favorable regarding the app's relative advantage over existing PE practices, compatibility with their values and needs, and complexity. Age (<40 years), smartphone ownership, and having used apps in care related to more favorable perceptions. Smartphone ownership, relative advantage, and complexity significantly predicted intention to use the app if it were available. These findings suggest that clinicians are receptive to using a PE app and that dissemination efforts should target sub-groups of PE clinicians to maximize adoption.

Making sense of mobile health data: an open architecture to improve individual- and population-level health.

Mobile phones and devices, with their constant presence, data connectivity, and multiple intrinsic sensors, can support around-the-clock chronic disease prevention and management that is integrated with daily life. These mobile health (mHealth) devices can produce tremendous amounts of location-rich, real-time, high-frequency data. Unfortunately, these data are often full of bias, noise, variability, and gaps. Robust tools and techniques have not yet been developed to make mHealth data more meaningful to patients and clinicians. To be most useful, health data should be sharable across multiple mHealth applications and connected to electronic health records. The lack of data sharing and dearth of tools and techniques for making sense of health data are critical bottlenecks limiting the impact of mHealth to improve health outcomes. We describe Open mHealth, a nonprofit organization that is building an open software architecture to address these data sharing and "sense-making" bottlenecks. Our architecture consists of open source software modules with well-defined interfaces using a minimal set of common metadata. An initial set of modules, called InfoVis, has been developed for data analysis and visualization. A second set of modules, our Personal Evidence Architecture, will support scientific inferences from mHealth data. These Personal Evidence Architecture modules will include standardized, validated clinical measures to support novel evaluation methods, such as n-of-1 studies. All of Open mHealth's modules are designed to be reusable across multiple applications, disease conditions, and user populations to maximize impact and flexibility. We are also building an open community of developers and health innovators, modeled after the open approach taken in the initial growth of the Internet, to foster meaningful cross-disciplinary collaboration around new tools and techniques. An open mHealth community and architecture will catalyze increased mHealth efficiency, effectiveness, and innovation.