An Evidence-Based HIV Risk-Reduction Intervention for Young African American Women in the US South Using mHealth: Adaptation and Development Study.

BACKGROUND: Young African American women have higher rates of sexually transmitted infections, including HIV, than those of young women of other racial and ethnic groups. Gender-, culture-, and age-specific interventions are needed to end the HIV epidemic. The Women's CoOp (WC) is an HIV risk-reduction intervention that is proven to be efficacious in various face-to-face formats. OBJECTIVE: This study aims to adapt the delivery method of an evidence-based intervention, the WC, from an in-person format to a self-guided mobile health (mHealth) format while ensuring that core elements are maintained for intervention comparability and fidelity. METHODS: Several adaptation phases were conducted by using the Personal Health Informatics and Intervention Toolkit (PHIT) as a guiding point to create the mobile app version of the WC. Throughout 5 phases, we established the implementation groundwork for the app; conducted formative research activities to test the initial draft of the app and obtain feedback; applied the PHIT toolkit programming structure to produce the mHealth version of the WC intervention; conducted usability testing and pretesting with interested parties, followed by in-house testing by WC interventionists and PHIT developers; and deployed the app to tablets and distributed it to study participants. The app underwent regular maintenance updates during the study. RESULTS: The team converted the seven elements of the WC as accurately as possible for comparability to determine efficacy in a mobile app format while changing little about the basic delivery methods. For instance, cue card presentations of the materials delivered by the intervention staff were presented within the app but with voice-over narration and in a self-guided format rather than being led by a staff member. Other aspects of the intervention did not lend themselves to such straightforward adaptation, such as hands-on condom proficiency practice and one-on-one goal-setting activities. In these cases, the subject matter experts and app developers worked together to find comparable analogs to be used within the app. Once developed, tested, and finalized, the mHealth WC app was deployed into local health departments as part of a randomized trial. CONCLUSIONS: This systematic adaptation process created an accurate mHealth equivalent of an existing, in-person behavioral health intervention. Although participants' reception of the app during the formative developmental phase was overall positive, maintaining fidelity to the in-person delivery compromised the natural capabilities of a mobile app, such as further gamification, different types of interactivity, and integrated notifications and messaging, which could be helpful for participants' adherence to the intervention schedule. Given the development and implementation of the app, the next step is to examine the impact of the app and its efficacy in HIV and substance use risk-reduction.

Use of Mobile Technology Paired with Heart Rate Monitor to Remotely Quantify Behavioral Health Markers among Military Reservists and First Responders.

INTRODUCTION: Heart rate variability (HRV) is a biological marker that reflects an individual's autonomic nervous system regulation. Psychological resilience is an individual's ability to recover from an adverse event and return to physiological homeostasis and mental well-being, indicated by higher resting HRV. The Biofeedback Assisted Resilience Training (BART) study evaluates a resilience-building intervention, with or without HRV biofeedback. This article evaluates the feasibility of remote psychophysiological research by validating the HRV data collected. MATERIALS AND METHODS: The BART platform consists of a mobile health application (BART app) paired to a wearable heart rate monitor. The BART app is installed on the participant's personal phone/tablet to track and collect self-report psychological and physiological data. The platform collects raw heart rate data and processes HRV to server as online biofeedback. The raw data is processed offline to derive HRV for statistical analysis. The following HRV parameters are validated: inter-beat interval, respiratory sinus arrhythmia, low-frequency HRV, biofeedback HRV, and heart period. Bland-Altman and scatter plots are used to compare and contrast online and offline HRV measures. Repeated-measures ANOVA are used to compared means across tasks during the stress (rest, stress, and recovery) and training (rest and paced breathing) sessions in order to validate autonomic nervous system changes to physiological challenges. RESULTS: The analyses included 245 participants. Bland-Altman plots showed excellent agreement and minimal bias between online and offline unedited inter-beat interval data during the stress session. RMANOVA during the training session indicated a significant strong effect on biofeedback HRV, F(11,390) = 967.96, P < .01. During the stress session, RMANOVA showed significant strong effect on respiratory sinus arrhythmia and low-frequency HRV, and a significant but weak effect on heart period. CONCLUSIONS: The BART digital health platform supports remote behavioral and physiological data collection, intervention delivery, and online HRV biofeedback.

The Development and Pilot Testing of an Evidence-Based Cardiovascular Disease Risk-Prevention Program to Promote Healthy Lifestyle Behaviors Among African-American College Students - Rams Have HEART.

Objectives: Cardiovascular disease (CVD) is the leading cause of death in the United States. Among the risk factors for college students, obesity and physical inactivity are disproportionately high among African Americans (AAs), and while studies of the obesity epidemic have increased in recent years, few target AA college-aged students. This study developed and piloted an evidence-based, 15-week, 3-credit hour, CVD risk-prevention and intervention course, Rams Have HEART that used e-learning, web-based technologies, and a mobile application and compared its effects against a control course. Methods: Two cohorts were recruited in a two-year period; 124 AA college students voluntarily consented to participate in the study, with n = 63 representing the control group and n = 61 representing the intervention. CVD risk factors were assessed by examining blood markers and anthropometric measurements. Demographic, clinical, and survey data (physical measures, blood marker investigation, and self-report surveys) were collected at baseline, post-intervention, and follow-up over the academic year. Results: The mean blood markers for lipid panel and glucose results were within the established optimal range. Intake of fruits and vegetables increased along with knowledge of CVD risk factors; 86% of students enrolled in the intervention passed the course; 100% (n = 61) would recommend it to future students. Conclusion: Developing and offering a healthy lifestyle-behavior CVD intervention course to AA college students is feasible and effective in optimizing their awareness of chronic disease risk factors and prompting behavior change.

Rams Have Heart, a Mobile App Tracking Activity and Fruit and Vegetable Consumption to Support the Cardiovascular Health of College Students: Development and Usability Study.

BACKGROUND: With the increasing use of mobile devices to access the internet and as the main computing system of apps, there is a growing market for mobile health apps to provide self-care advice. Their effectiveness with regard to diet and fitness tracking, for example, needs to be examined. The majority of American adults fail to meet daily recommendations for healthy behavior. Testing user engagement with an app in a controlled environment can provide insight into what is effective and not effective in an app focused on improving diet and exercise. OBJECTIVE: We developed Rams Have Heart, a mobile app, to support a cardiovascular disease (CVD) intervention course. The app tracks healthy behaviors, including fruit and vegetable consumption and physical activity, throughout the day. This paper aimed to present its functionality and evaluated adherence among the African American college student population. METHODS: We developed the app using the Personal Health Informatics and Intervention Toolkit, a software framework. Rams Have Heart integrates self-reported health screening with health education, diary tracking, and user feedback modules to acquire data and assess progress. The parent study, conducted at a historically black college and university-designated institution in southeastern United States, consisted of a semester-long intervention administered as an academic course in the fall, for 3 consecutive years. Changes were made after the cohort 1 pilot study, so results only include cohorts 2 and 3, comprising a total of 115 students (n=55 intervention participants and n=54 control participants) aged from 17 to 24 years. Data collected over the study period were transferred using the secure Hypertext Transfer Protocol Secure protocol and stored in a secure Structured Query Language server database accessible only to authorized persons. SAS software was used to analyze the overall app usage and the specific results collected. RESULTS: Of the 55 students in the intervention group, 27 (49%) students in cohort 2 and 25 (45%) in cohort 3 used the Rams Have Heart app at least once. Over the course of the fall semester, app participation dropped off gradually until exam week when most students no longer participated. The average fruit and vegetable intake increased slightly, and activity levels decreased over the study period. CONCLUSIONS: Rams Have Heart was developed to allow daily tracking of fruit and vegetable intake and physical activity to support a CVD risk intervention for a student demographic susceptible to obesity, heart disease, and type 2 diabetes. We conducted an analysis of app usage, function, and user results. Although a mobile app provides privacy and flexibility for user participation in a research study, Rams Have Heart did not improve compliance or user outcomes. Health-oriented research studies relying on apps in support of user goals need further evaluation.

Adapting Mindfulness Training for Military Service Members With Chronic Pain.

INTRODUCTION: Rates of chronic pain in military personnel are disproportionately high. Chronic pain is often associated with mental health and substance use disorders as comorbid conditions, making treatment of chronic pain complex. Mindfulness-based interventions (MBIs) are a promising behavioral approach to managing chronic pain and psychosocial sequelae. The unique nature of the military context may require adaptations to original MBIs for successful delivery in active-duty military populations. This study adapted the mindfulness-based stress reduction (MBSR) program to create a mindfulness training program that was relevant to active-duty Army personnel experiencing chronic pain. This article delineates the adaptation process employed to modify the MBSR program to the military context and discusses the resulting training program. MATERIALS AND METHODS: The adaptation process consisted of three iterative stages: 1) Drafting the preliminary intervention protocol with recommendations from stakeholders, including military healthcare providers; 2) Refining the preliminary protocol after pretesting the sessions with research team members and a military Veteran advisory committee; and 3) Delivering the preliminary protocol to one cohort of active-duty Soldiers with chronic pain, collecting feedback, and further refining the intervention protocol. RESULTS: Military-related adaptations to MBSR addressed three areas: military culture, language and terminology, and practical and logistical factors relevant to implementation in the military setting. This adaptation process resulted in a live, online program with six, weekly, sessions. Feedback from a military Veteran advisory committee resulted in modifications, including increasing military-relevant examples; preliminary testing with the target population resulted in additional modifications, including shortening the sessions to 75 min and structuring discussions more efficiently. CONCLUSIONS: The adaptation process was successful in generating an engaging mindfulness training program that was highly relevant to the military context. Obtaining input from stakeholders, such as military healthcare providers and active-duty soldiers, and iterative feedback and modification, were key to the process. Moreover, the program was designed to maintain the integrity and core elements of MBIs while adapting to military culture. A future randomized controlled trial design will be used to evaluate the effectiveness of the intervention in improving chronic pain in military personnel. This program is responsive to the military's call for nonpharmacologic treatments for chronic pain that are easily accessible. If effective, the mindfulness program has the potential for widespread dissemination to complement standard care for Service Members experiencing chronic pain.

Mental health, stress, and resilience correlates of heart rate variability among military reservists, guardsmen, and first responders.

The use of heart rate variability (HRV) for monitoring stress has been growing in the behavioral health literature, especially in the areas of posttraumatic stress disorder, stress reactivity, and resilience. Few studies, however, have included general populations under workplace conditions. This study evaluates whether military and other first responders show lower HRV during stress than at baseline and greater post stress rebound, controlling for a myriad of potential confounders. A convenience sample of Reserves, National Guard, veteran, fire, and police personnel provided HRV and self-reported questionnaire responses before, during, and after a cognitive-stressor task with a smart phone application. Timing of HRV application; mental and physical health scores; coping and posttraumatic growth indicators, including being open to new possibilities; and emotional support were predictors of trajectories of the HRV response to stress. Findings from this exploratory study emphasize the strong link between stress and relaxation breathing in both respiratory sinus arrhythmia and low frequency heart rate variability and the need for controlling potential covariates for understanding the relationship between HRV and the stress response and providing a basis for hypothesis driven research.

Biofeedback-Assisted Resilience Training for Traumatic and Operational Stress: Preliminary Analysis of a Self-Delivered Digital Health Methodology.

BACKGROUND: Psychological resilience is critical to minimize the health effects of traumatic events. Trauma may induce a chronic state of hyperarousal, resulting in problems such as anxiety, insomnia, or posttraumatic stress disorder. Mind-body practices, such as relaxation breathing and mindfulness meditation, help to reduce arousal and may reduce the likelihood of such psychological distress. To better understand resilience-building practices, we are conducting the Biofeedback-Assisted Resilience Training (BART) study to evaluate whether the practice of slow, paced breathing with or without heart rate variability biofeedback can be effectively learned via a smartphone app to enhance psychological resilience. OBJECTIVE: Our objective was to conduct a limited, interim review of user interactions and study data on use of the BART resilience training app and demonstrate analyses of real-time sensor-streaming data. METHODS: We developed the BART app to provide paced breathing resilience training, with or without heart rate variability biofeedback, via a self-managed 6-week protocol. The app receives streaming data from a Bluetooth-linked heart rate sensor and displays heart rate variability biofeedback to indicate movement between calmer and stressful states. To evaluate the app, a population of military personnel, veterans, and civilian first responders used the app for 6 weeks of resilience training. We analyzed app usage and heart rate variability measures during rest, cognitive stress, and paced breathing. Currently released for the BART research study, the BART app is being used to collect self-reported survey and heart rate sensor data for comparative evaluation of paced breathing relaxation training with and without heart rate variability biofeedback. RESULTS: To date, we have analyzed the results of 328 participants who began using the BART app for 6 weeks of stress relaxation training via a self-managed protocol. Of these, 207 (63.1%) followed the app-directed procedures and completed the training regimen. Our review of adherence to protocol and app-calculated heart rate variability measures indicated that the BART app acquired high-quality data for evaluating self-managed stress relaxation training programs. CONCLUSIONS: The BART app acquired high-quality data for studying changes in psychophysiological stress according to mind-body activity states, including conditions of rest, cognitive stress, and slow, paced breathing.

mHealth versus face-to-face: study protocol for a randomized trial to test a gender-focused intervention for young African American women at risk for HIV in North Carolina.

BACKGROUND: Disparities in the prevalence of HIV persist in the southern United States, and young African American women have a disproportionate burden of HIV as compared with young women of other racial/ethnic backgrounds. As a result, engaging young African American women in the HIV care continuum through HIV testing is imperative. This study is designed to reach this key population at risk for HIV. The study seeks to test the efficacy of two formats of a gender-focused, evidence-based, HIV-risk reduction intervention-the Young Women's CoOp (YWC)-relative to HIV counseling and testing (HCT) among young African American women between the ages of 18 and 25 who use substances and have not recently been tested for HIV. METHODS: Using a seek-and-test framework, this three-arm cross-over randomized trial is being conducted in three county health departments in North Carolina. Each county is assigned to one of three study arms in each cycle: in-person (face-to-face) YWC, mobile Health (mHealth) YWC, or HCT. At study enrollment, participants complete a risk behavior survey via audio computer-assisted self-interview, and drug, alcohol, and pregnancy screening tests, and are then referred to HIV, gonorrhea, and chlamydia testing through their respective health departments. Participants in either of the YWC arms are asked to return approximately 1 week later to either begin the first of two in-person individual intervention sessions or to pick up the mHealth intervention preloaded on a tablet after a brief introduction to using the app. Participants in all arms are asked to return for a 6-month follow-up and 12-month follow-up, and repeat the survey and biological testing from baseline. DISCUSSION: The findings from this study will demonstrate which delivery format (mHealth or face-to-face) is efficacious in reducing substance use and sexual risk behaviors. If found to be efficacious, the intervention has potential for wider dissemination and reach. TRIAL REGISTRATION: ClinicalTrials.gov: NCT02965014 . Registered November 16, 2016.

PHIT for Duty, a Mobile Application for Stress Reduction, Sleep Improvement, and Alcohol Moderation.

Post-traumatic stress and other problems often occur after combat, deployment, and other military operations. Because techniques such as mindfulness meditation show efficacy in improving mental health, our team developed a mobile application (app) for individuals in the armed forces with subclinical psychological problems as secondary prevention of more significant disease. Based on the Personal Health Intervention Toolkit (PHIT), a mobile app framework for personalized health intervention studies, PHIT for Duty integrates mindfulness-based relaxation, behavioral education in sleep quality and alcohol use, and psychometric and psychophysiological data capture. We evaluated PHIT for Duty in usability and health assessment studies to establish app quality for use in health research. Participants (N = 31) rated usability on a 1 (very hard) to 5 (very easy) scale and also completed the System Usability Scale (SUS) questionnaire (N = 9). Results were (mean ± SD) overall (4.5 ± 0.6), self-report instruments (4.5 ± 0.7), pulse sensor (3.7 ± 1.2), sleep monitor (4.4 ± 0.7), sleep monitor comfort (3.7 ± 1.1), and wrist actigraphy comfort (2.7 ± 0.9). The average SUS score was 85 ± 12, indicating a rank of 95%. A comparison of PHIT-based assessments to traditional paper forms demonstrated a high overall correlation (r = 0.87). These evaluations of usability, health assessment accuracy, physiological sensing, system acceptability, and overall functionality have shown positive results and affirmation for using the PHIT framework and PHIT for Duty application in mobile health research.

A personal health information toolkit for health intervention research.

With the emergence of mobile health (mHealth) apps, there is a growing demand for better tools for developing and evaluating mobile health interventions. Recently we developed the Personal Health Intervention Toolkit (PHIT), a software framework which eases app implementation and facilitates scientific evaluation. PHIT integrates self-report and physiological sensor instruments, evidence-based advisor logic, and self-help interventions such as meditation, health education, and cognitive behavior change. PHIT can be used to facilitate research, interventions for chronic diseases, risky behaviors, sleep, medication adherence, environmental monitoring, momentary data collection health screening, and clinical decision support. In a series of usability evaluations, participants reported an overall usability score of 4.5 on a 1-5 Likert scale and an 85 score on the System Usability Scale, indicating a high percentile rank of 95%.

PHIT for duty, a mobile approach for psychological health intervention.

The goal of this effort is to support prevention of psychological health problems through innovation in mobile personal health assessment and self-help intervention (SHI). For the U.S. military, we are developing and evaluating a field-deployable personalized application, PHIT for DutyTM, to help build resilience in healthy troops and support prevention in high-risk personnel. PHIT for Duty is delivered using any smartphone or tablet with optional nonintrusive physiological and behavioral sensors for health status monitoring. The application integrates a suite of health assessments with an intelligent advisor that recommends, tailors, and presents self-help advisories. PHIT for Duty is intended for secondary prevention of psychological health problems in persons who have been exposed to psychological trauma and may be showing some symptoms of distress, but have not been diagnosed with any psychological disease or disorder.

Virtual simulation-enhanced triage training for Iraqi medical personnel.

Triage, establishing the priority of care among casualties in disaster management, is generally practiced using constructive tabletop or live exercises. Actual disasters involving multiple casualties occur rarely, offering little opportunity for gaining experience and competency assessment. When they do occur, response needs to be rapid and well-learned. In the Iraqi medical education environment where the need for triage is immediate, but the ability to stage practice is nearly impossible, blending didactic learning with simulation-based triage offers an alternative training methodology.

Lessons learned in modeling virtual pediatric patients.

In two applications the authors are developing virtual pediatric characters for training and assessment. One application, a virtual pediatric standardized patient, is intended for medical school students rotating through pediatrics to train and assess their basic communications and procedural skills while interacting with kids. The other application presents at-risk teenagers with vignettes to assess risky behavior and impulsivity. Both applications rely on existing responsive virtual human technology. The authors are engaged in preliminary clinical trials for the work described in this paper.