LiveWell, a smartphone-based self-management intervention for bipolar disorder: Intervention participation and usability analysis.

BACKGROUND: Understanding how individuals utilize and perceive digital mental health interventions may improve engagement and effectiveness. To support intervention improvement, participant feedback was obtained and app use patterns were examined for a randomized clinical trial evaluating a smartphone-based intervention for individuals with bipolar disorder. METHODS: App use and coaching engagement were examined (n = 124). Feedback was obtained via exit questionnaires (week 16, n = 81) and exit interviews (week 48, n = 17). RESULTS: On average, over 48 weeks, participants used the app for 4.4 h and engaged with the coach for 3.9 h. Participants spent the most time monitoring target behaviors and receiving adaptive feedback and the least time viewing self-assessments and skills. Participants reported that the daily check in helped increase awareness of target behaviors but expressed frustration with repetitiveness of monitoring and feedback content. Participants liked personalizing their wellness plan, but its use did not facilitate skills practice. App use declined over time which participants attributed to clinical stability, content mastery, and time commitment. Participants found the coaching supportive and motivating for app use. LIMITATIONS: App engagement based on viewing time may overestimate engagement. The delay between intervention delivery and the exit interviews and low exit interview participation may introduce bias. CONCLUSION: Utilization patterns and feedback suggest that digital mental health engagement and efficacy may benefit from adaptive personalization of targets monitored combined with adaptive monitoring and feedback to support skills practice and development. Increasing engagement with supports may also be beneficial.

Effects of a Smartphone-Based Self-management Intervention for Individuals With Bipolar Disorder on Relapse, Symptom Burden, and Quality of Life: A Randomized Clinical Trial.

Importance: Bipolar disorder-specific psychotherapy combined with pharmacotherapy improves relapse risk, symptom burden, and quality of life, but psychotherapy is not easily accessible. Objective: To determine if a smartphone-based self-management intervention (LiveWell) can assist individuals with bipolar disorder to maintain wellness. Design, Setting, and Participants: An assessor-blind randomized clinical trial enrolled participants from March 20, 2017, to April 25, 2019, with 48-week follow-up ending on April 10, 2020. Participants were randomly assigned to usual care or usual care plus the smartphone intervention stratified by relapse risk based on initial clinical status (low risk: asymptomatic recovery; high risk: continued symptomatic, prodromal, recovering, symptomatic recovery). Participants with bipolar disorder I were recruited from clinics in the Chicago and Minneapolis-Saint Paul areas. Data were analyzed from June 19, 2020, to May 25, 2022. Interventions: The smartphone-based self-management intervention consisted of an application (app), coach, and website. Over 16 weeks, participants had a coach visit followed by 6 phone calls, and they completed daily and weekly app check-ins. The app provided adaptive feedback and information for developing a personalized wellness plan, the coach provided support, and the website provided summary data and alerts. Main Outcomes and Measures: The primary outcome was time to relapse. Secondary outcomes were percentage-time symptomatic, symptom severity, and quality of life. Results: Of the 205 randomized participants (mean [SD] age, 42 [12] years; 125 female individuals [61%]; 5 Asian [2%], 21 Black [10%], 13 Hispanic or Latino [6%], 7 multiracial [3%], 170 White [83%], 2 unknown race [1%]), 81 (40%) were randomly assigned to usual care, and 124 (60%) were randomly assigned to usual care plus the smartphone intervention. This clinical trial did not detect a reduction in relapse risk for the smartphone intervention (hazard ratio [HR], 0.65; 95% CI, 0.39-1.09; log-rank P = .08). However, decreased relapse was observed for low-risk individuals (HR, 0.32; 95% CI, 0.12-0.88; log-rank P = .02) but not high-risk individuals (HR, 0.86; 95% CI, 0.47-1.57; log-rank P = .62). Reduced manic symptom severity was observed for low-risk individuals (mean [SE] difference, -1.4 [0.4]; P = .001) but not for high-risk individuals (mean [SE] difference, 0 [0.3]; P = .95). The smartphone-based self-management intervention decreased depressive symptom severity (mean [SE] difference, -0.80 [0.34]; P = .02) and improved relational quality of life (mean [SE] difference, 1.03 [0.45]; P = .02) but did not decrease percentage-time symptomatic (mean [SE] difference, -5.6 [4.3]; P = .20). Conclusions and Relevance: This randomized clinical trial of a smartphone-based self-management intervention did not detect a significant improvement in the primary outcome of time to relapse. However, a significant decrease in relapse risk was observed for individuals in asymptomatic recovery. In addition, the intervention decreased depressive symptom severity and improved relational quality of life. These findings warrant further work to optimize the smartphone intervention and confirm that the intervention decreases relapse risk for individuals in asymptomatic recovery. Trial Registration: ClinicalTrials.gov Identifier: NCT03088462.

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.

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 Individuals with Bipolar Disorder (LiveWell): Qualitative Study on User Experiences of the Behavior Change Process.

BACKGROUND: Bipolar disorder is a severe mental illness characterized by recurrent episodes of depressed, elevated, and mixed mood states. The addition of psychotherapy to pharmacological management can decrease symptoms, lower relapse rates, and improve quality of life; however, access to psychotherapy is limited. Mental health technologies such as smartphone apps are being studied as a means to increase access to and enhance the effectiveness of adjunctive psychotherapies for bipolar disorder. Individuals with bipolar disorder find this intervention format acceptable, but our understanding of how people utilize and integrate these tools into their behavior change and maintenance processes remains limited. OBJECTIVE: The objective of this study was to explore how individuals with bipolar disorder perceive and utilize a smartphone intervention for health behavior change and maintenance. METHODS: Individuals with bipolar disorder were recruited via flyers placed at university-affiliated and private outpatient mental health practices to participate in a pilot study of LiveWell, a smartphone-based self-management intervention. At the end of the study, all participants completed in-depth qualitative exit interviews. The behavior change framework developed to organize the intervention design was used to deductively code behavioral targets and determinants involved in target engagement. Inductive coding was used to identify themes not captured by this framework. RESULTS: In terms of behavioral targets, participants emphasized the importance of managing mood episode-related signs and symptoms. They also discussed the importance of maintaining regular routines, sleep duration, and medication adherence. Participants emphasized that receiving support from a coach as well as seeking and receiving assistance from family, friends, and providers were important for managing behavioral targets and staying well. In terms of determinants, participants stressed the important role of monitoring for their behavior change and maintenance efforts. Monitoring facilitated self-awareness and reflection, which was considered valuable for staying well. Some participants also felt that the intervention facilitated learning information necessary for managing bipolar disorder but others felt that the information provided was too basic. CONCLUSIONS: In addition to addressing acceptability, satisfaction, and engagement, a person-based design of mental health technologies can be used to understand how people experience the impact of these technologies on their behavior change and maintenance efforts. This understanding may then be used to guide ongoing intervention development. The participants' perceptions aligned with the intervention's primary behavioral targets and use of a monitoring tool as a core intervention feature. Participant feedback further indicates that developing additional content and tools to address building and engaging social support may be an important avenue for improving LiveWell. A comprehensive behavior change framework to understand participant perceptions of their behavior change and maintenance efforts may help facilitate ongoing intervention development.

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.

Development of Coaching Support for LiveWell: A Smartphone-Based Self-Management Intervention for Bipolar Disorder.

Despite effective pharmacological treatment, bipolar disorder is a leading cause of disability due to recurrence of episodes, long episode durations, and persistence of interepisode symptoms. While adding psychotherapy to pharmacotherapy improves outcomes, the availability of adjunctive psychotherapy is limited. To extend the accessibility and functionality of psychotherapy for bipolar disorder, we developed LiveWell, a smartphone-based self-management intervention. Unfortunately, many mental health technology interventions suffer from high attrition rates, with users rapidly failing to maintain engagement with the intervention technology. Human support reduces this commonly observed engagement problem but does not consistently improve clinical and recovery outcomes. To facilitate ongoing efforts to develop human support for digital mental health technologies, this paper describes the design decisions, theoretical framework, content, mode, timing of delivery, and the training and supervision for coaching support of the LiveWell technology. This support includes clearly defined and structured roles that aim to encourage the use of the technology, self-management strategies, and communication with care providers. A clear division of labor is established between the coaching support roles and the intervention technology to allow lay personnel to serve as coaches and thereby maximize accessibility to the LiveWell intervention.

Cognitive-behavioral group therapy for insomnia in individuals with serious mental illnesses: a preliminary evaluation.

Chronic insomnia is a problem among individuals with serious mental illnesses. In an effort to expand treatment options, we examined whether well-established cognitive-behavioral treatments for insomnia developed for individuals in the general population generalize to those for people with serious mental illnesses. Individuals participated in comprehensive sleep evaluations and cognitive-behavioral therapy. Results suggest that sleep problems often began during periods of distress and/or exacerbation of illness but were maintained by environmental, behavioral, and cognitive factors. With the treatment, participants reported improvement in many sleep parameters. Initial indication is that cognitive-behavioral therapy does generalize. More rigorous research seems warranted.

Interpretations of child compliance in individuals at high- and low-risk for child physical abuse.

OBJECTIVE: Our studies compared individuals at high- and low-risk for child physical abuse on measures of social information processing. METHOD: Two studies were conducted using similar methods. Twenty-eight childless women in Study 1 and 36 mothers in Study 2 read vignettes of parent-child interactions in which the child's level of compliance was difficult to interpret. Participants were asked a series of questions about the child's behavior and their own reactions. RESULTS: Accuracy and bias in identifying compliant behavior were assessed using a signal detection paradigm. In both samples, high- and low-risk participants did not differ in their overall accuracy in identifying children's behaviors. However, they used different evaluation standards such that high-risk participants were biased toward seeing more noncompliance and low-risk participants were biased toward seeing more compliance. High- and low-risk participants also made different types of errors in interpreting children's behavior. Low-risk participants were more likely to misinterpret noncompliant behavior as compliant, and there was a trend for high-risk participants to not perceive compliant behavior when it occurred. There were no differences in reported disciplinary responses in either study and the results for affective reactions were mixed. CONCLUSIONS: Specific differences in social information processing between high- and low-risk individuals replicated across samples, suggesting a reliable association between evaluation standards and risk of child physical abuse. However, the absence of differences in reported discipline and inconsistent findings on affective reactions indicate the need to identify the mechanism through which cognition influences parenting behavior.