Empirical and Theoretical Framework, Intervention Design, and Study Protocol for a Randomized Controlled Trial of LiveWell: A Smartphone-based Self-management Intervention for Individuals with Bipolar Disorder (Preprint)

BACKGROUND Bipolar disorder is a severe mental illness with high levels of morbidity and mortality. Even with pharmacologic treatment, frequent recurrence of episodes, long episode durations, and persistent inter-episode symptoms are common and disruptive. Combining psychotherapy with pharmacotherapy improves outcomes, but access to therapy is limited and 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, application use, and behavioral data collection to advance understanding of the longitudinal course of bipolar disorder which can then be utilized to support ongoing improvement of treatment. OBJECTIVE To facilitate the ability to replicate, improve, implement and disseminate effective interventions for bipolar disorder, we provide a description of the theoretical and empirically supported framework, design, and protocol for a randomized controlled trial of LiveWell: a smartphone-based self-management intervention for individuals with bipolar disorder. The goal of this trial is to determine the effectiveness of LiveWell for reducing relapse risk and symptom burden, while simultaneously elucidating behavioral targets of the intervention and better characterizing bipolar disorder course and treatment response. METHODS The study is a single blind randomized controlled trial (N = 205, 2:3 ratio of usual care vs usual care plus LiveWell). The primary outcome is time to relapse. Secondary outcomes are percent time symptomatic, symptom severity, and quality of life. 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, application use and personalized content will be created with the aim of better predicting treatment response and relapse risk. RESULTS Recruitment and screening started in March 2017 and ended in April 2019. Follow up ended April 2020. The study results are expected to be published in 2021. CONCLUSIONS This study will examine the potential of LiveWell for reducing relapse risk and symptom burden in individuals with bipolar disorder by increasing access to empirically supported self-management strategies. Simultaneously, a database will be created to initiate development of algorithms to personalize and improve treatment for bipolar disorder. Additionally, we hope that the description of the theoretical and empirically supported framework, intervention design, and study protocol for the randomized controlled trial of LiveWell provided here will facilitate the ability to replicate, improve, implement and disseminate effective interventions for bipolar disorder. CLINICALTRIAL ClinicalTrials.gov NCT03088462