A Mobile Behavioral Monitoring Intervention for Bipolar Disorder

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.

Inclusion Criteria:

- DSM-IV diagnosis of Bipolar Disorder Type I.

- Minimum of 2 acute episodes in last 2 years.

- Receiving psychiatric care from a mental health provider willing to receive
notifications and information regarding subject symptom status via the LiveWell
system.

Exclusion Criteria:

- Not involved in current psychiatric care.

- Current substance use disorders or other psychiatric diagnosis or symptoms (e.g.
dissociate disorder, psychotic symptoms) for which participation in this study is
either inappropriate or dangerous.

- Pregnancy or plans to become pregnant.

- Visual impairments limiting mobile phone use.

- An inability to speak and read English.