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

Evan H Goulding, Cynthia A Dopke, Rebecca C Rossom, Tania Michaels, Clair R Martin, Chloe Ryan, Geneva Jonathan, Alyssa McBride, Pamela Babington, Mary Bernstein, Andrew Bank, C Spencer Garborg, Jennifer M Dinh, Mark Begale, Mary J Kwasny, David C Mohr, Evan H Goulding, Cynthia A Dopke, Rebecca C Rossom, Tania Michaels, Clair R Martin, Chloe Ryan, Geneva Jonathan, Alyssa McBride, Pamela Babington, Mary Bernstein, Andrew Bank, C Spencer Garborg, Jennifer M Dinh, Mark Begale, Mary J Kwasny, David C Mohr

Abstract

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.

Keywords: bipolar disorder; eHealth; mHealth; mental health; mobile health; mobile phone; self-management; smartphone.

Conflict of interest statement

Conflicts of Interest: EHG has accepted honoraria from Otsuka Pharmaceuticals. DCM has accepted honoraria and consulting fees from Apple, Inc, Otsuka Pharmaceuticals, Pear Therapeutics, and the One Mind Foundation, royalties from Oxford Press, and has an ownership interest in Adaptive Health, Inc.

©Evan H Goulding, Cynthia A Dopke, Rebecca C Rossom, Tania Michaels, Clair R Martin, Chloe Ryan, Geneva Jonathan, Alyssa McBride, Pamela Babington, Mary Bernstein, Andrew Bank, C Spencer Garborg, Jennifer M Dinh, Mark Begale, Mary J Kwasny, David C Mohr. Originally published in JMIR Research Protocols (https://www.researchprotocols.org), 21.02.2022.

Figures

Figure 1
Figure 1
Behavior change framework.
Figure 2
Figure 2
Behavior change process.
Figure 3
Figure 3
Intervention design: arrows outside gray boxes on left side indicate provider and coach access to dashboard and email communications and on right side user access to the dashboard and smartphone app. Arrows between providers, coach, user, family and friends represent interactions between the user and supports. In the case of the coach, interactions with the user and provider may be prompted by email alerts. Arrows within the app represent the user app workflow. Information in the Foundation lessons and Toolbox is used to develop a personalized Wellness Plan, including daily monitoring using the Daily Check-In. Daily Check-In data are used to provide feedback via the Daily Review. The Daily Review feedback directs the user to relevant app content in their Wellness Plan or the Foundations and Toolbox.
Figure 4
Figure 4
Smartphone App Design: Dashed lines indicate app components available based on timing (Daily and Weekly Check-Ins) or completion of other components (Daily Review, Review Something Else). EWS: early warning signs; MSS: manage signs and symptoms; PHQ: Patient Health Questionnaire 8; AMRS: Altman Mania Rating Scale; i: Instructions; gear symbol: settings.
Figure 5
Figure 5
Daily Check-In and Daily Review: (A) Upon opening the LiveWell app, user views the home page with Daily Check-In highlighted indicating task to be completed, (B) User completes Daily Check-In with a wellness rating of -2 indicating possible early warning signs of depression, (C) After user submits Daily Check-In data, Daily Review feedback page displays summary of last 7 check-ins. Expert system identifies a possible shift in mood down as priority, (D-E) User continues through Daily Review and receives information about Awareness and Action, F. Last page of Daily Review suggests user check My Skills in Resources in the Wellness Plan. Daily Review feedback truncated here for display.
Figure 6
Figure 6
Study timeline.

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