Rethinking Data Collection Methods During the Pandemic: Development and Implementation of CATI for the All of Us Research Program.

The All of Us Research Program is a longitudinal cohort study aiming to build a diverse database to advance precision medicine. The COVID-19 pandemic hindered the ability of participants to receive in-person assistance at enrollment sites to complete digital surveys. Therefore, the program implemented Computer-Assisted Telephone Interviewing (CATI) to facilitate survey completion remotely to combat the disrupted data collection procedures. In January 2021, All of Us implemented a 1-year CATI Pilot supporting 9399 participants and resulting in 16 337 submitted surveys. The pilot showed that CATI was successful in increasing survey completion and retention activities for the All of Us Research Program, given the additional remote support offered to participants. Given the success of the CATI Pilot, multimodal survey administration will continue.

Design and Implementation of the All of Us Research Program COVID-19 Participant Experience (COPE) Survey.

In response to the rapidly evolving coronavirus disease 2019 (COVID-19) pandemic, the All of Us Research Program longitudinal cohort study developed the COVID-19 Participant Experience (COPE) survey to better understand the pandemic experiences and health impacts of COVID-19 on diverse populations within the United States. Six survey versions were deployed between May 2020 and March 2021, covering mental health, loneliness, activity, substance use, and discrimination, as well as COVID-19 symptoms, testing, treatment, and vaccination. A total of 104,910 All of Us Research Program participants, of whom over 73% were from communities traditionally underrepresented in biomedical research, completed 275,201 surveys; 9,693 completed all 6 surveys. Response rates varied widely among demographic groups and were lower among participants from certain racial and ethnic minority populations, participants with low income or educational attainment, and participants with a Spanish language preference. Survey modifications improved participant response rates between the first and last surveys (13.9% to 16.1%, P < 0.001). This paper describes a data set with longitudinal COVID-19 survey data in a large, diverse population that will enable researchers to address important questions related to the pandemic, a data set that is of additional scientific value when combined with the program's other data sources.

Symptom burden profiles in men with advanced prostate cancer undergoing androgen deprivation therapy.

To identify symptom burden profiles among men with advanced prostate cancer undergoing androgen-deprivation therapy and examine their association with baseline sociodemographic and medical characteristics and psychosocial outcomes over time. Latent profile analysis was employed to identify distinct groups based on the Expanded Prostate Index Composite and the McGill Pain Questionnaire at baseline. Psychosocial outcomes were assessed at baseline, 6- and 12-month follow-ups. Three profiles emerged: "high symptom burden," "high sexual bother," and "low symptom burden." Men with "high symptom burden" were younger and exhibited higher baseline levels of depression, stress, cancer-specific distress, and anxiety than men in the other two groups. However, men with "high symptom burden" also demonstrated improvement in these psychosocial outcomes over time. Men with advanced prostate cancer who experience multiple co-occurring symptoms demonstrate worse psychosocial adjustment. Patients with substantial symptom burden, and specifically young men, may benefit from prompt referral to supportive care services.

Effects of web-based cognitive behavioral stress management and health promotion interventions on neuroendocrine and inflammatory markers in men with advanced prostate cancer: A randomized controlled trial.

Cognitive behavioral stress management (CBSM) improves quality of life and mitigates stress biology in patients with early-stage cancer, including men with localized prostate cancer. However, treatments for advanced prostate cancer like androgen deprivation therapy (ADT) can lead to significant symptom burden that may be further exacerbated by stress-induced inflammation and cortisol dysregulation. The aim of this study was to examine the effects of CBSM (versus an active health promotion control) on circulating inflammatory markers and cortisol in men with advanced prostate cancer. METHODS: Men with stage III or IV prostate cancer (N = 192) who had undergone ADT within the last year were randomized to CBSM or health promotion. Both interventions were 10 weeks, group-based, and delivered online. Venous blood was drawn at baseline, 6 months, and 12 months to measure circulating levels of CRP, IL-6, IL-8, IL-10, and TNF-α. Saliva samples were collected at awakening, 30 min after awakening, evening, and night for two consecutive days at baseline, 6-months, and 12-months to measure diurnal cortisol slopes. RESULTS: Mixed modeling analyses demonstrated that changes in inflammatory markers and cortisol did not differ by intervention. Men in both CBSM and health promotion showed decreases in IL-10, IL-8, and TNF-α from baseline to 6 months (ß = -3.85--5.04, p's = 0.004-<0.001). However, these markers generally demonstrated a rebound increase from 6 to 12 months (ß = 1.91-4.06, p's = 0.06-<0.001). Men in health promotion also demonstrated a flatter diurnal cortisol slope versus men in CBSM at 6 months (ß = -2.27, p = .023), but not at 12 months. There were no intervention effects on CRP, IL-6, or overall cortisol output. CONCLUSIONS: Contrary to hypotheses, CBSM did not lead to changes in the circulating inflammatory markers and cortisol relative to health promotion. CBSM may be associated with healthy diurnal cortisol rhythm because of its focus on cognitive behavioral approaches to stress management. More research is needed to understand the impact of CBSM and health promotion on biomarkers among men with advanced prostate cancer.

Effect of a Digital Intervention on Depressive Symptoms in Patients With Comorbid Hypertension or Diabetes in Brazil and Peru: Two Randomized Clinical Trials.

Importance: Depression is a leading contributor to disease burden globally. Digital mental health interventions can address the treatment gap in low- and middle-income countries, but the effectiveness in these countries is unknown. Objective: To investigate the effectiveness of a digital intervention in reducing depressive symptoms among people with diabetes and/or hypertension. Design, Setting, and Participants: Participants with clinically significant depressive symptoms (Patient Health Questionnaire-9 [PHQ-9] score ≥10) who were being treated for hypertension and/or diabetes were enrolled in a cluster randomized clinical trial (RCT) at 20 sites in São Paulo, Brazil (N=880; from September 2016 to September 2017; final follow-up, April 2018), and in an individual-level RCT at 7 sites in Lima, Peru (N=432; from January 2017 to September 2017; final follow-up, March 2018). Interventions: An 18-session, low-intensity, digital intervention was delivered over 6 weeks via a provided smartphone, based on behavioral activation principles, and supported by nurse assistants (n = 440 participants in 10 clusters in São Paulo; n = 217 participants in Lima) vs enhanced usual care (n = 440 participants in 10 clusters in São Paulo; n = 215 participants in Lima). Main Outcomes and Measures: The primary outcome was a reduction of at least 50% from baseline in PHQ-9 scores (range, 0-27; higher score indicates more severe depression) at 3 months. Secondary outcomes included a reduction of at least 50% from baseline PHQ-9 scores at 6 months. Results: Among 880 patients cluster randomized in Brazil (mean age, 56.0 years; 761 [86.5%] women) and 432 patients individually randomized in Peru (mean age, 59.7 years; 352 [81.5%] women), 807 (91.7%) in Brazil and 426 (98.6%) in Peru completed at least 1 follow-up assessment. The proportion of participants in São Paulo with a reduction in PHQ-9 score of at least 50% at 3-month follow-up was 40.7% (159/391 participants) in the digital intervention group vs 28.6% (114/399 participants) in the enhanced usual care group (difference, 12.1 percentage points [95% CI, 5.5 to 18.7]; adjusted odds ratio [OR], 1.6 [95% CI, 1.2 to 2.2]; P = .001). In Lima, the proportion of participants with a reduction in PHQ-9 score of at least 50% at 3-month follow-up was 52.7% (108/205 participants) in the digital intervention group vs 34.1% (70/205 participants) in the enhanced usual care group (difference, 18.6 percentage points [95% CI, 9.1 to 28.0]; adjusted OR, 2.1 [95% CI, 1.4 to 3.2]; P < .001). At 6-month follow-up, differences across groups were no longer statistically significant. Conclusions and Relevance: In 2 RCTs of patients with hypertension or diabetes and depressive symptoms in Brazil and Peru, a digital intervention delivered over a 6-week period significantly improved depressive symptoms at 3 months when compared with enhanced usual care. However, the magnitude of the effect was small in the trial from Brazil and the effects were not sustained at 6 months. Trial Registration: ClinicalTrials.gov: NCT02846662 (São Paulo) and NCT03026426 (Lima).

Technology-Based Psychosocial Intervention to Improve Quality of Life and Reduce Symptom Burden in Men with Advanced Prostate Cancer: Results from a Randomized Controlled Trial.

BACKGROUND: Men with advanced prostate cancer (APC) face multiple challenges including poor prognosis, poor health-related quality of life (HRQOL), and elevated symptom burden. This study sought to establish the efficacy of a tablet-delivered, group-based psychosocial intervention for improving HRQOL and reducing symptom burden in men with APC. We hypothesized that men randomized to cognitive-behavioral stress management (CBSM) would report improved HRQOL and reduced symptom burden relative to men randomized to an active control health promotion (HP) condition. Condition effects on intervention targets and moderators of these effects were explored. METHODS: Men with APC (N = 192) were randomized (1:1) to 10-week tablet-delivered CBSM or HP, and followed for 1 year. Multilevel modeling was used to evaluate condition effects over time. RESULTS: Changes in HRQOL and symptom burden did not differ between groups. Men in both groups improved across several intervention targets; men in the CBSM condition reported greater increases in self-reported ability to relax, and both conditions showed improvements in cancer-related anxiety, cancer-related distress, and feelings of cohesiveness with other patients over time. Moderating factors included baseline interpersonal disruption, fatigue, and sexual functioning. CONCLUSIONS: Tablet-delivered CBSM and HP were well received by men with APC. The hypothesized effects of CBSM on HRQOL and symptom burden were not supported, though improvements in intervention targets were observed across conditions. Participants reported high-baseline HRQOL relative to cancer and general population norms, possibly limiting intervention effects. The identified moderating factors should be considered in the development and implementation of interventions targeting HRQOL and symptom burden. TRIAL REGISTRATION: ClinicalTrials.gov Identifier: NCT03149185.

Development of the Initial Surveys for the All of Us Research Program.

BACKGROUND: The All of Us Research Program is building a national longitudinal cohort and collecting data from multiple information sources (e.g., biospecimens, electronic health records, and mobile/wearable technologies) to advance precision medicine. Participant-provided information, collected via surveys, will complement and augment these information sources. We report the process used to develop and refine the initial three surveys for this program. METHODS: The All of Us survey development process included: (1) prioritization of domains for scientific needs, (2) examination of existing validated instruments, (3) content creation, (4) evaluation and refinement via cognitive interviews and online testing, (5) content review by key stakeholders, and (6) launch in the All of Us electronic participant portal. All content was translated into Spanish. RESULTS: We conducted cognitive interviews in English and Spanish with 169 participants, and 573 individuals completed online testing. Feedback led to over 40 item content changes. Lessons learned included: (1) validated survey instruments performed well in diverse populations reflective of All of Us; (2) parallel evaluation of multiple languages can ensure optimal survey deployment; (3) recruitment challenges in diverse populations required multiple strategies; and (4) key stakeholders improved integration of surveys into larger Program context. CONCLUSIONS: This efficient, iterative process led to successful testing, refinement, and launch of three All of Us surveys. Reuse of All of Us surveys, available at http://researchallofus.org, may facilitate large consortia targeting diverse populations in English and Spanish to capture participant-provided information to supplement other data, such as genetic, physical measurements, or data from electronic health records.

Feasibility, acceptability, and preliminary efficacy of a technology-assisted psychosocial intervention for racially diverse men with advanced prostate cancer.

BACKGROUND: The utility of psychosocial interventions in reducing symptom burden and improving health-related quality of life (HRQOL) for men with localized prostate cancer has been demonstrated. However, studies have yet to demonstrate the efficacy of interventions in advanced prostate cancer (APC). This study examined the feasibility, acceptability, and preliminary efficacy of a technology-assisted, 10-week, group-based psychosocial intervention for diverse men with APC. METHODS: The participants were 74 men (mean age, 68.84 years; non-Hispanic white, 57%; black, 40.5%) who were randomized to a cognitive-behavioral stress management (CBSM) treatment or health promotion (HP) attention-control condition. The participants were assessed at the baseline, weekly throughout the 10-week program, and 6 months after the baseline. Outcomes were assessed with the Patient-Reported Outcomes Measurement Information System along with established measures of HRQOL, CBSM intervention targets (eg, relaxation skills), and patient-reported acceptability. RESULTS: Feasibility was demonstrated through good retention rates (>85%) and acceptable average attendance rates (>70%), and acceptability was demonstrated through very favorable weekly session evaluations (mean score, 4/5) and exit surveys (mean score, 3.6/4). Men randomized to the CBSM condition reported significant reductions (P < .05) in depressive symptoms and improvements in relaxation self-efficacy (P < .05) at the 6-month follow-up. CBSM participants reported trends for improvement in distress and functional well-being (P < .08) in comparison with those in the HP condition. Effect sizes ranged from medium (0.54) to large (1.87) and, in some instances, were clinically meaningful. CONCLUSIONS: Technology-based CBSM interventions among diverse men with APC may be feasible, acceptable, and efficacious.

Strategies for mHealth research: lessons from 3 mobile intervention studies.

The capacity of Mobile Health (mHealth) technologies to propel healthcare forward is directly linked to the quality of mobile interventions developed through careful mHealth research. mHealth research entails several unique characteristics, including collaboration with technologists at all phases of a project, reliance on regional telecommunication infrastructure and commercial mobile service providers, and deployment and evaluation of interventions "in the wild", with participants using mobile tools in uncontrolled environments. In the current paper, we summarize the lessons our multi-institutional/multi-disciplinary team has learned conducting a range of mHealth projects using mobile phones with diverse clinical populations. First, we describe three ongoing projects that we draw from to illustrate throughout the paper. We then provide an example for multidisciplinary teamwork and conceptual mHealth intervention development that we found to be particularly useful. Finally, we discuss mHealth research challenges (i.e. evolving technology, mobile phone selection, user characteristics, the deployment environment, and mHealth system "bugs and glitches"), and provide recommendations for identifying and resolving barriers, or preventing their occurrence altogether.

Purple: a modular system for developing and deploying behavioral intervention technologies.

The creation, deployment, and evaluation of Web-based and mobile-based applications for health, mental health, and wellness within research settings has tended to be siloed, with each research group developing their own systems and features. This has led to technological features and products that are not sharable across research teams, thereby limiting collaboration, reducing the speed of dissemination, and raising the bar for entry into this area of research. This paper provides an overview of Purple, an extensible, modular, and repurposable system created for the development of Web-based and mobile-based applications for health behavior change. Purple contains features required to construct applications and to manage and evaluate research trials using these applications. Core functionality of Purple includes elements that support user management, content authorship, content delivery, and data management. We discuss the history and development of the Purple system guided by the rationale of producing a system that allows greater collaboration and understanding across research teams interested in investigating similar questions and using similar methods. Purple provides a useful tool to meet the needs of stakeholders involved in the creation, provision, and usage of eHealth and mHealth applications. Housed in a non-profit, academic institution, Purple also offers the potential to facilitate the diffusion of knowledge across the research community and improve our capacity to deliver useful and usable applications that support the behavior change of end users.

Skin self-examination education for early detection of melanoma: a randomized controlled trial of Internet, workbook, and in-person interventions.

BACKGROUND: Early detection of melanoma improves survival. Since many melanoma patients and their spouses seek the care of a physician after discovering their melanoma, an ongoing study will determine the efficacy of teaching at-risk melanoma patients and their skin check partner how to conduct skin self-examinations (SSEs). Internet-based health behavior interventions have proven efficacious in creating behavior change in patients to better prevent, detect, or cope with their health issues. The efficacy of electronic interactive SSE educational intervention provided on a tablet device has not previously been determined. OBJECTIVE: The electronic interactive educational intervention was created to develop a scalable, effective intervention to enhance performance and accuracy of SSE among those at-risk to develop melanoma. The intervention in the office was conducted using one of the following three methods: (1) in-person through a facilitator, (2) with a paper workbook, or (3) with a tablet device used in the clinical office. Differences related to method of delivery were elucidated by having the melanoma patient and their skin check partner provide a self-report of their confidence in performing SSE and take a knowledge-based test immediately after receiving the intervention. METHODS: The three interventions used 9 of the 26 behavioral change techniques defined by Abraham and Michie to promote planning of monthly SSE, encourage performing SSE, and reinforce self-efficacy by praising correct responses to knowledge-based decision making and offering helpful suggestions to improve performance. In creating the electronic interactive SSE educational intervention, the educational content was taken directly from both the scripted in-person presentation delivered with Microsoft PowerPoint by a trained facilitator and the paper workbook training arms of the study. Enrollment totaled 500 pairs (melanoma patient and their SSE partner) with randomization of 165 pairs to the in-person, 165 pairs to the workbook, and 70 pairs to electronic interactive SSE educational intervention. RESULTS: The demographic survey data showed no significant mean differences between groups in age, education, or income. The tablet usability survey given to the first 30 tablet pairs found that, overall, participants found the electronic interactive intervention easy to use and that the video of the doctor-patient-partner dialogue accompanying the dermatologist's examination was particularly helpful in understanding what they were asked to do for the study. The interactive group proved to be just as good as the workbook group in self-confidence of scoring moles, and just as good as both the workbook and the in-person intervention groups in self-confidence of monitoring their moles. While the in-person intervention performed significantly better on a skill-based quiz, the electronic interactive group performed significantly better than the workbook group. The electronic interactive and in-person interventions were more efficient (30 minutes), while the workbook took longer (45 minutes). CONCLUSIONS: This study suggests that an electronic interactive intervention can deliver skills training comparable to other training methods, and the experience can be accommodated during the customary outpatient office visit with the physician. Further testing of the electronic interactive intervention's role in the anxiety of the pair and pair-discovered melanomas upon self-screening will elucidate the impact of these tools on outcomes in at-risk patient populations. TRIAL REGISTRATION: ClinicalTrials.gov NCT01013844; http://clinicaltrials.gov/show/NCT01013844 (Archived by WebCite at http://www.webcitation.org/6LvGGSTKK).

Project onward: an innovative e-health intervention for cancer survivors.

OBJECTIVE: This study examined the feasibility and acceptability of an Individual Internet Intervention (III) embedded and integrated into an Internet Support Group (ISG) with the ultimate goal of enhancing adherence and learning, compared with an individual internet invention alone. METHOD: Thirty-one posttreatment cancer survivors were randomized in groups of seven to nine to either the 8-week III + ISG intervention or the 8-week III condition. Seventeen participants met the Hospital Anxiety and Depression Scale (HADS) criteria for depressive symptoms (HADS ≥ 8). RESULTS: Among all participants, the mean number of logins over 8 weeks was 20.8 ± 17.7 logins for the III + ISG compared with 12.5 ± 12.5 in III-only (p = 0.15). Two participants in the III + ISG dropped out, compared with five in III (p = 0.39). Among the 17 participants with depressive symptoms at baseline, both the Onward and the III-only condition showed large reductions in the depression scale of HADS (d = 1.27 and 0.89, respectively). Improvement over time and time x treatment effects only reached trend significance levels (ps = 0.07 & 0.12) as this pilot was not powered to detect these differences. CONCLUSION: Both the III + ISG and III-only demonstrated pre-post reductions in depressive symptoms and high rates of utilization compared with other web-based treatments for depression. Although it is premature to make any determination as to the efficacy of the interventions tested in this feasibility study, these results indicate that pursuing the III + ISG model, as well as standard IIIs, may be fruitful areas of future research.

A Smartphone-Based Self-management Intervention for Individuals With Bipolar Disorder (LiveWell): Empirical and Theoretical Framework, Intervention Design, and Study Protocol for a Randomized Controlled Trial.

BACKGROUND: Bipolar disorder is a severe mental illness with high morbidity and mortality rates. Even with pharmacological treatment, frequent recurrence of episodes, long episode durations, and persistent interepisode symptoms are common and disruptive. Combining psychotherapy with pharmacotherapy improves outcomes; however, many individuals with bipolar disorder do not receive psychotherapy. Mental health technologies can increase access to self-management strategies derived from empirically supported bipolar disorder psychotherapies while also enhancing treatment by delivering real-time assessments, personalized feedback, and provider alerts. In addition, mental health technologies provide a platform for self-report, app use, and behavioral data collection to advance understanding of the longitudinal course of bipolar disorder, which can then be used to support ongoing improvement of treatment. OBJECTIVE: A description of the theoretical and empirically supported framework, design, and protocol for a randomized controlled trial (RCT) of LiveWell, a smartphone-based self-management intervention for individuals with bipolar disorder, is provided to facilitate the ability to replicate, improve, implement, and disseminate effective interventions for bipolar disorder. The goal of the trial is to determine the effectiveness of LiveWell for reducing relapse risk and symptom burden as well as improving quality of life (QOL) while simultaneously clarifying behavioral targets involved in staying well and better characterizing the course of bipolar disorder and treatment response. METHODS: The study is a single-blind RCT (n=205; 2:3 ratio of usual care vs usual care plus LiveWell). The primary outcome is the time to relapse. Secondary outcomes are percentage time symptomatic, symptom severity, and QOL. Longitudinal changes in target behaviors proposed to mediate the primary and secondary outcomes will also be determined, and their relationships with the outcomes will be assessed. A database of clinical status, symptom severity, real-time self-report, behavioral sensor, app use, and personalized content will be created to better predict treatment response and relapse risk. RESULTS: Recruitment and screening began in March 2017 and ended in April 2019. Follow-up ended in April 2020. The results of this study are expected to be published in 2022. CONCLUSIONS: This study will examine whether LiveWell reduces relapse risk and symptom burden and improves QOL for individuals with bipolar disorder by increasing access to empirically supported self-management strategies. The role of selected target behaviors (medication adherence, sleep duration, routine, and management of signs and symptoms) in these outcomes will also be examined. Simultaneously, a database will be created to initiate the development of algorithms to personalize and improve treatment for bipolar disorder. In addition, we hope that this description of the theoretical and empirically supported framework, intervention design, and study protocol for the RCT of LiveWell will facilitate the ability to replicate, improve, implement, and disseminate effective interventions for bipolar and other mental health disorders. TRIAL REGISTRATION: ClinicalTrials.gov NCT03088462; https://www.clinicaltrials.gov/ct2/show/NCT03088462. INTERNATIONAL REGISTERED REPORT IDENTIFIER (IRRID): DERR1-10.2196/30710.

Harnessing context sensing to develop a mobile intervention for depression.

BACKGROUND: Mobile phone sensors can be used to develop context-aware systems that automatically detect when patients require assistance. Mobile phones can also provide ecological momentary interventions that deliver tailored assistance during problematic situations. However, such approaches have not yet been used to treat major depressive disorder. OBJECTIVE: The purpose of this study was to investigate the technical feasibility, functional reliability, and patient satisfaction with Mobilyze!, a mobile phone- and Internet-based intervention including ecological momentary intervention and context sensing. METHODS: We developed a mobile phone application and supporting architecture, in which machine learning models (ie, learners) predicted patients' mood, emotions, cognitive/motivational states, activities, environmental context, and social context based on at least 38 concurrent phone sensor values (eg, global positioning system, ambient light, recent calls). The website included feedback graphs illustrating correlations between patients' self-reported states, as well as didactics and tools teaching patients behavioral activation concepts. Brief telephone calls and emails with a clinician were used to promote adherence. We enrolled 8 adults with major depressive disorder in a single-arm pilot study to receive Mobilyze! and complete clinical assessments for 8 weeks. RESULTS: Promising accuracy rates (60% to 91%) were achieved by learners predicting categorical contextual states (eg, location). For states rated on scales (eg, mood), predictive capability was poor. Participants were satisfied with the phone application and improved significantly on self-reported depressive symptoms (beta(week) = -.82, P < .001, per-protocol Cohen d = 3.43) and interview measures of depressive symptoms (beta(week) = -.81, P < .001, per-protocol Cohen d = 3.55). Participants also became less likely to meet criteria for major depressive disorder diagnosis (b(week) = -.65, P = .03, per-protocol remission rate = 85.71%). Comorbid anxiety symptoms also decreased (beta(week) = -.71, P < .001, per-protocol Cohen d = 2.58). CONCLUSIONS: Mobilyze! is a scalable, feasible intervention with preliminary evidence of efficacy. To our knowledge, it is the first ecological momentary intervention for unipolar depression, as well as one of the first attempts to use context sensing to identify mental health-related states. Several lessons learned regarding technical functionality, data mining, and software development process are discussed. TRIAL REGISTRATION: Clinicaltrials.gov NCT01107041; http://clinicaltrials.gov/ct2/show/NCT01107041 (Archived by WebCite at http://www.webcitation.org/60CVjPH0n).

A Smartphone-Based Self-management Intervention for Individuals With Bipolar Disorder (LiveWell): Protocol Development for an Expert System to Provide Adaptive User Feedback.

BACKGROUND: Bipolar disorder is a severe mental illness that results in significant morbidity and mortality. While pharmacotherapy is the primary treatment, adjunctive psychotherapy can improve outcomes. However, access to therapy is limited. Smartphones and other technologies can increase access to therapeutic strategies that enhance self-management while simultaneously augmenting care by providing adaptive delivery of content to users as well as alerts to providers to facilitate clinical care communication. Unfortunately, while adaptive interventions are being developed and tested to improve care, information describing the components of adaptive interventions is often not published in sufficient detail to facilitate replication and improvement of these interventions. OBJECTIVE: To contribute to and support the improvement and dissemination of technology-based mental health interventions, we provide a detailed description of the expert system for adaptively delivering content and facilitating clinical care communication for LiveWell, a smartphone-based self-management intervention for individuals with bipolar disorder. METHODS: Information from empirically supported psychotherapies for bipolar disorder, health psychology behavior change theories, and chronic disease self-management models was combined with user-centered design data and psychiatrist feedback to guide the development of the expert system. RESULTS: Decision points determining the timing of intervention option adaptation were selected to occur daily and weekly based on self-report data for medication adherence, sleep duration, routine, and wellness levels. These data were selected for use as the tailoring variables determining which intervention options to deliver when and to whom. Decision rules linking delivery of options and tailoring variable thresholds were developed based on existing literature regarding bipolar disorder clinical status and psychiatrist feedback. To address the need for treatment adaptation with varying clinical statuses, decision rules for a clinical status state machine were developed using self-reported wellness rating data. Clinical status from this state machine was incorporated into hierarchal decision tables that select content for delivery to users and alerts to providers. The majority of the adaptive content addresses sleep duration, medication adherence, managing signs and symptoms, building and utilizing support, and keeping a regular routine, as well as determinants underlying engagement in these target behaviors as follows: attitudes and perceptions, knowledge, support, evaluation, and planning. However, when problems with early warning signs, symptoms, and transitions to more acute clinical states are detected, the decision rules shift the adaptive content to focus on managing signs and symptoms, and engaging with psychiatric providers. CONCLUSIONS: Adaptive mental health technologies have the potential to enhance the self-management of mental health disorders. The need for individuals with bipolar disorder to engage in the management of multiple target behaviors and to address changes in clinical status highlights the importance of detailed reporting of adaptive intervention components to allow replication and improvement of adaptive mental health technologies for complex mental health problems.

A Smartphone-Based Self-management Intervention for Bipolar Disorder (LiveWell): User-Centered Development Approach.

BACKGROUND: Bipolar disorder is a serious mental illness that results in significant morbidity and mortality. Pharmacotherapy is the primary treatment for bipolar disorder; however, adjunctive psychotherapy can help individuals use self-management strategies to improve outcomes. Yet access to this therapy is limited. Smartphones and other technologies have the potential to increase access to therapeutic strategies that enhance self-management while simultaneously providing real-time user feedback and provider alerts to augment care. OBJECTIVE: This paper describes the user-centered development of LiveWell, a smartphone-based self-management intervention for bipolar disorder, to contribute to and support the ongoing improvement and dissemination of technology-based mental health interventions. METHODS: Individuals with bipolar disorder first participated in a field trial of a simple smartphone app for self-monitoring of behavioral targets. To develop a complete technology-based intervention for bipolar disorder, this field trial was followed by design sessions, usability testing, and a pilot study of a smartphone-based self-management intervention for bipolar disorder. Throughout all phases of development, intervention revisions were made based on user feedback. RESULTS: The core of the LiveWell intervention consists of a daily self-monitoring tool, the Daily Check-in. This self-monitoring tool underwent multiple revisions during the user-centered development process. Daily Check-in mood and thought rating scales were collapsed into a single wellness rating scale to accommodate user development of personalized scale anchors. These anchors are meant to assist users in identifying early warning signs and symptoms of impending episodes to take action based on personalized plans. When users identified personal anchors for the wellness scale, the anchors most commonly reflected behavioral signs and symptoms (40%), followed by cognitive (25%), mood (15%), physical (10%), and motivational (7%) signs and symptoms. Changes to the Daily Check-in were also made to help users distinguish between getting adequate sleep and keeping a regular routine. At the end of the pilot study, users reported that the Daily Check-in made them more aware of early warning signs and symptoms and how much they were sleeping. Users also reported that they liked personalizing their anchors and plans and felt this process was useful. Users experienced some difficulties with developing, tracking, and achieving target goals. Users also did not consistently follow up with app recommendations to contact providers when Daily Check-in data suggested they needed additional assistance. As a result, the human support roles for the technology were expanded beyond app use support to include support for self-management and clinical care communication. The development of these human support roles was aided by feedback on the technology's usability from the users and the coaches who provided the human support. CONCLUSIONS: User input guided the development of intervention content, technology, and coaching support for LiveWell. Users valued the provision of monitoring tools and the ability to personalize plans for staying well, supporting the role of monitoring and personalization as important features of digital mental health technologies. Users also valued human support of the technology in the form of a coach, and user difficulties with aspects of self-management and care-provider communication led to an expansion of the coach's support roles. Obtaining feedback from both users and coaches played an important role in the development of both the LiveWell technology and human support. Attention to all stakeholders involved in the use of mental health technologies is essential for optimizing intervention development.

Multimodal e-mental health treatment for depression: a feasibility trial.

BACKGROUND: Internet interventions for depression have shown less than optimal adherence. This study describes the feasibility trial of a multimodal e-mental health intervention designed to enhance adherence and outcomes for depression. The intervention required frequent brief log-ins for self-monitoring and feedback as well as email and brief telephone support guided by a theory-driven manualized protocol. OBJECTIVE: The objective of this feasibility trial was to examine if our Internet intervention plus manualized telephone support program would result in increased adherence rates and improvement in depression outcomes. METHODS: This was a single arm feasibility trial of a 7-week intervention. RESULTS: Of the 21 patients enrolled, 2 (9.5%) dropped out of treatment. Patients logged in 23.2 ± 12.2 times over the 7 weeks. Significant reductions in depression were found on all measures, including the Patient Health Questionnaire depression scale (PHQ-8) (Cohen's d = 1.96, P < .001), the Hamilton Rating Scale for Depression (d = 1.34, P < .001), and diagnosis of major depressive episode (P < .001). CONCLUSIONS: The attrition rate was far lower than seen either in Internet studies or trials of face-to-face interventions, and depression outcomes were substantial. These findings support the feasibility of providing a multimodal e-mental health treatment to patients with depression. Although it is premature to make any firm conclusions based on these data, they do support the initiation of a randomized controlled trial examining the independent and joint effects of Internet and telephone administered treatments for depression.

RADAR-Base: Open Source Mobile Health Platform for Collecting, Monitoring, and Analyzing Data Using Sensors, Wearables, and Mobile Devices.

BACKGROUND: With a wide range of use cases in both research and clinical domains, collecting continuous mobile health (mHealth) streaming data from multiple sources in a secure, highly scalable, and extensible platform is of high interest to the open source mHealth community. The European Union Innovative Medicines Initiative Remote Assessment of Disease and Relapse-Central Nervous System (RADAR-CNS) program is an exemplary project with the requirements to support the collection of high-resolution data at scale; as such, the Remote Assessment of Disease and Relapse (RADAR)-base platform is designed to meet these needs and additionally facilitate a new generation of mHealth projects in this nascent field. OBJECTIVE: Wide-bandwidth networks, smartphone penetrance, and wearable sensors offer new possibilities for collecting near-real-time high-resolution datasets from large numbers of participants. The aim of this study was to build a platform that would cater for large-scale data collection for remote monitoring initiatives. Key criteria are around scalability, extensibility, security, and privacy. METHODS: RADAR-base is developed as a modular application; the backend is built on a backbone of the highly successful Confluent/Apache Kafka framework for streaming data. To facilitate scaling and ease of deployment, we use Docker containers to package the components of the platform. RADAR-base provides 2 main mobile apps for data collection, a Passive App and an Active App. Other third-Party Apps and sensors are easily integrated into the platform. Management user interfaces to support data collection and enrolment are also provided. RESULTS: General principles of the platform components and design of RADAR-base are presented here, with examples of the types of data currently being collected from devices used in RADAR-CNS projects: Multiple Sclerosis, Epilepsy, and Depression cohorts. CONCLUSIONS: RADAR-base is a fully functional, remote data collection platform built around Confluent/Apache Kafka and provides off-the-shelf components for projects interested in collecting mHealth datasets at scale.

Integrating PROMIS® computerized adaptive tests into a web-based intervention for prostate cancer.

OBJECTIVE: This study outlined the implementation and feasibility of delivering PROMIS® computer adaptive tests (CATs) using a web-based method to evaluate the impact of a technological adaptation of Cognitive-Behavioral Stress Management (CBSM) on the psychosocial functioning of men with advanced prostate cancer (APC) undergoing hormone therapy. METHOD: Patients were randomized to a CBSM group intervention (n = 95) or a health promotion (HP) attention-matched control condition (n = 97). Participants attended all sessions via video conference using tablets, and completed PROMIS® computer adaptive tests (CATs) assessing anxiety, depression, fatigue, pain interference, and physical function weekly during the 10-week intervention. RESULTS: Assessment completion rates >50% at week 1 and week 10 demonstrated moderate feasibility of repeatedly administering PROMIS® CATs using a web-based method. Multilevel modeling demonstrated no significant group-by-time interactions from week 1 to week 10 for any of the assessed PROMIS® domains adjusting for sociodemographic and medical covariates. However, simple effects demonstrated decreases in PROMIS® anxiety scores from week 1 to 10 for both groups. Results also demonstrated significant relationships of medical variables to psychosocial functioning across time points. CONCLUSIONS: Results highlight the feasibility and benefits of utilizing PROMIS® CATs to repeatedly assess psychosocial functioning using a web-based method and indicate that web-based interventions may be effective for decreasing psychosocial distress and adverse symptoms among men with APC undergoing hormone therapy. (PsycINFO Database Record (c) 2019 APA, all rights reserved).