Development of a Personalized Real-time Intervention for Bipolar Disorder

This three-year intervention development proposal is submitted to the NIMH DATR Mood
Disorders/Sleep Disorders Program A2-AID and is led by a New Investigator. The goal of this
study is to further develop and then evaluate the clinical utility of a new personalized
smart-phone intervention to enhance illness self-management in people with bipolar disorder.
Bipolar disorder is a heterogeneous fluctuating condition and a leading source of disability.
Consistent with NIMH Strategic Aim 3.2, self-monitoring tools are vital to clinical
management and evidence-based psychosocial interventions for bipolar disorder. Practice
guidelines state that all patients should receive education in self-monitoring and
identifying adaptive responses to early warning signs and symptoms. Advances in technology
have enabled electronic monitoring of patient-reported outcomes using mobile devices - an
assessment strategy called Ecological Momentary Assessment (EMA). Using freely available
software, we have developed a preliminary version of a novel smart-phone intervention that
integrates EMA with brief psychosocial intervention designed for people with bipolar
disorder. Mobile real-time interventions have been successfully applied in other chronic
illnesses and have theoretical advantages over clinic-based interventions in motivating and
cuing health-protective behavior. Our new intervention is called Personalized Real-Time
Intervention for Stabilizing Mood (PRISM), and it delivers tailored intervention content
naturalistically at the moment that symptoms occur. We recently conducted a small
proof-of-concept study of PRISM in outpatient adults with bipolar disorder that suggests the
intervention is feasible, presents no technological or operational barriers, yields data that
corresponds with clinical ratings, and is perceived as useful by participants. Building from
our preliminary work, we propose to further develop the intervention based on participant
feedback and theoretically-driven enhancements. We will then conduct a randomized trial to
assess the clinical utility of this new intervention over 12 weeks. Specifically, we will
randomize a sample of 90 adults aged 18 and older with Bipolar Disorder I or II to one of two
experimental conditions. Participants in both conditions will participate in two in-person
sessions adapted from an evidence-based psychosocial intervention for bipolar disorder, aimed
at identifying early warning signs and adaptive responses to symptom fluctuations. The
Control condition will participate in the in-person sessions, and the PRISM condition will
also utilize the smart phone device for 12 weeks. In this pilot trial, we will compare
outcomes between the two conditions on standard clinical ratings of depressive and manic
symptoms, along with psychosocial functioning. We will assess predictors of compliance and
changes in outcomes in the PRISM condition to inform a larger effectiveness trial. We will
use exploratory analyses to further refine the intervention, including capitalizing on the
rich repeated measures obtained by the device. This study will provide a strong basis for a
larger effectiveness trial, along with a potentially useful tool to enhance self-management
in bipolar disorder. PUBLIC HEALTH RELEVANCE: Bipolar disorder is a leading cause of
disability, and many people do not have access to evidence-based psychosocial interventions.
Mobile devices may prove more effective than clinic-based interventions, because they deliver
self-management strategies at the moment that symptoms occur. To lead to a larger
effectiveness study, we propose to further develop our novel intervention uses mobile
technology to monitor and intervene with symptoms in real-time, and then conduct a 12-week
randomized trial in 90 patients to evaluate the acceptability and short-term efficacy of our
smart-phone based intervention for bipolar disorder.