A Mobile Behavioral Monitoring Intervention for Bipolar Disorder
Condition: Bipolar Disorder
MeSH terms: Bipolar Disorder
Study type: Interventional

Summary: 
      This study will develop and pilot a smartphone intervention, LiveWell, to enhance patient
      self-management of bipolar disorder and facilitate more efficient, timely care delivery by
      mental health providers. The intervention uses a mobile application to collect daily
      self-report and continuous behavioral data and adapts intervention content to create a highly
      tailored and user-responsive treatment system. Patient data collected by the phone will also
      be provided to clinicians to allow for better evaluation and targeting of treatment. The goal
      is to reduce symptoms and prevent relapse in patients with bipolar disorder.
    

Detailed description: 
      Bipolar disorder is a severe and chronic mental illness that significantly increases
      mortality and greatly impairs functioning. Despite the use of pharmacological treatments,
      multiple acute episodes, long episode duration, and significant inter-episode sub-syndromal
      symptoms are common in patients with bipolar disorder. As a result, patients with bipolar
      disorder are symptomatically ill about half the time. There is clear evidence that the
      addition of psychotherapeutic interventions to medication management improves treatment
      outcomes, yet only about half of bipolar patients receive combined treatment. Current
      therapies also have limitations in terms of: 1) reliance on subjective patient self report
      and 2) difficulties in identifying warning signs of impending episodes. Furthermore, direct
      measurement of observable daily patterns of behavior is not routinely available, even though
      alterations in sleep and activity are core symptoms of bipolar disorder. Improving access to
      and long-term engagement in psychosocial interventions is needed to substantially improve
      treatment.

      The investigators are developing a smartphone intervention that aims to make proven
      psychosocial interventions for bipolar disorder more readily and routinely accessible to
      patients as part of their day-to-day lives. The intervention, called LiveWell, will capture
      and feedback data about sleep and activity to assist patients in regularizing daily rhythms
      as well as help them monitor, recognize, and manage early warning signs of impending mood
      episodes. Behavioral and self-report data collected by the phone will also be used to provide
      clinicians with information regarding patient clinical status. This will increase
      patient-provider communication and allow for better evaluation and targeting of treatment.

      Participation in the study will last 4 months. All participants will first undergo initial
      assessments that will include a telephone interview and a face-to-face interview with a
      certified study psychiatrist for the purpose of confirming diagnosis. Eligible participants
      will then be assigned randomly to the LiveWell or TAU group. Participants assigned to either
      group will be provided with a smartphone and wrist-worn device, and will be asked to carry
      the phones with them whenever they leave home and to wear the wrist-worn devices 24-hours a
      day 7 days a week. Participants assigned to the LiveWell intervention will be asked to
      undergo a 16 week psychosocial intervention consisting of phone-based self-monitoring and
      educational tools to help them learn skills to better manage symptoms. Participants assigned
      to the TAU group will be asked to provide limited self-report data on wellness and sleep. All
      participants, regardless of assigned group, will be asked to participate in assessments
      delivered over the phone to assess presence and severity of mood symptoms.
    

Intervention name(s): LiveWell System
Intervention type(s): Behavioral
Intervention description(s): For 16 weeks, participants will be asked to carry a mobile phone and wear a wrist-worn device for measuring activity. Participants in this arm will receive the psychosocial intervention via a smartphone and context-dependent feedback based on self-report and behavioral data. Providers whose patients are randomized to this arm will also be asked to enroll in order to receive information and notifications about patient status for the duration of the study
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary purpose: Treatment
Keywords: Bipolar Disorder; Behavior Therapy; Technology Assisted; Mobile Phone; Smartphone