Patient Management of Depression Through Technology: a Study of Digitally Enabled Engagement

This pilot study will be a randomized, real-world effectiveness study. Patients diagnosed
with major depressive disorder starting a new prescription for an antidepressant monotherapy
will be eligible for participation. The study will enroll 40 patients (20 in an observational
arm of usual care and 20 with access to a mobile health application). No intervention will
occur in the usual care arm. The intervention in this study is a mobile health app, which
provides patients with a way to track emotional wellbeing and depression symptoms, set up
medication reminders, track adherence to medications, record side effects experienced, and
take surveys/tests to assess cognitive symptoms and depression. Patient reported outcomes and
clinical data will be collected at baseline and at study primary endpoint (18 weeks) to
assess changes over time and between groups for: patient-provider engagement, disease
severity, quality of life, employment productivity, cognitive function, resource utilization,
and medication adherence. Additionally, resource utilization will be assessed at the one year
time point. A Student's t test, if allowed for by the data distribution, will be used to
assess between group differences in patient reported outcome scales assessing
patient-provider engagement.

Inclusion Criteria:

- Age 18 to 70

- Ability to consent and participate in study (technical requirements for app: iPhone
version 5 or later, active data plan or regular WiFi access)

- Diagnosis with major depressive disorder

- PHQ-9 score greater than 5 at baseline

- Recent (0-14 days) start on monotherapy depression medication (either new prescription
or a change from a previous medication)

- Outpatient care provided by participating Advocate Medical Group clinics

Exclusion Criteria:

- Diagnosis with major psychiatric disorder (e.g. bipolar disorder, manic depressive
disorder)

- Contraindications to use of depression medications

- Patients with treatment resistant depression [defined as patients who have not
responded to two or more separate different antidepressant monotherapy trials of
adequate dose and duration (6 weeks or longer) in the current depressive episode]

- Considered at imminent risk for hospitalization due to severe depression in the
opinion of the treating physician

- History of hospitalization due to major depressive disorder in prior 3 months

- Significant risk of suicide according to the treating physician's clinical judgment or
previous suicide attempt in prior 6 months

- History of response only to combination or augmentation therapy in current depressive
episode

- Receipt of any investigational compound in prior 30 days (or five half-lives,
whichever is longer)

- Current participation in another clinical study

- Lack of functional English literacy