IntelliCare Study: Artificial Intelligence in a Mobile (AIM) Intervention for Depression

Major depressive disorder (MDD) is a common mental disorder, with up to 10.3% of the
population experiencing the disorder in a given 12-month period. The relationship between
depression and anxiety has been well documented. Depression is a significant predictor of
future anxiety, and anxiety is a significant predictor of future onset of depression. Indeed,
studies find that more than 50% of all individuals with MDD also have a current anxiety
disorder. Although effective treatments have been developed over the years to address
depression and anxiety, the lack of personalization and inability to adapt to patient needs
or preferences contributes to poor treatment adherence and outcomes.

An intelligent treatment system was developed that uses state of the art machine learning
approaches within a mobile intervention application to treat MDD and anxiety. Machine
learning, a branch of artificial intelligence, focuses on the development of algorithms that
automatically improve and evolve based on collected data. The intervention, called
IntelliCare, uses a mobile application to continuously collect patient data and adapt
intervention content and motivational messaging to create a highly tailored and
user-responsive treatment system.

During the RCT study, 270 participants with Major Depression and/or Anxiety will use
IntelliCare apps for up to 8 weeks and will be invited to complete online questionnaires at
four follow-up time points: weeks 4 and 8 in the study program, and months 3 and 6 after the
study program ends. All participants will first undergo initial assessments that will include
a telephone interview and a series of online questionnaires about their mood. Eligible
participants will receive up to 8 weeks of access to the IntelliCare system, which consists
of apps with lessons and tools designed to teach skills for mood management. It is suggested
that participants utilize the mobile phone tools every day.

Participants will be randomly assigned to one of two versions of the IntelliCare Hub App,
which is the central delivery system for the IntelliCare program, and participants will also
be randomly assigned to get support from a human coach or use the IntelliCare program
independently.

Each week, participants assigned to work with a coach will receive a brief motivational
intervention. This coach will also be available to participants via email throughout the 8
week study. Participants randomly assigned to use the IntelliCare program independently will
receive an on-boarding guide to set up the IntelliCare Hub App on their phone, and
participants will have access to our tech support team if technical difficulties arise while
using the program.

Data from the RCT study will be used to examine whether: the IntelliCare program is an
effective intervention for reducing depressive and anxiety symptoms; the recommender system
will produce greater program adherence and; support from a coach or independent use might
affect user experience and adherence. Data collected will also be used to further develop and
evaluate machine learning methods for future research and deployment efforts.

Inclusion Criteria:

- Meets criteria for clinically significant symptoms of depression and/or anxiety using
self-report measures used in screening for depression

- Is familiar with the use of mobile phones

- Owns an Android smartphone and is willing download the IntelliCare apps on their own
device

- Is able to speak and read English

- Is at least 18 years of age (* Note: Depending on which state individual resides in,
the age to consent to research may be 19 years of age.)

- Is able to give informed consent

Exclusion Criteria:

Participants were excluded if they had visual, voice, motor or hearing impairments that
would prevent participation; met diagnostic criteria for a severe psychiatric disorders for
which study treatments would be inappropriate; severe suicidality that included both a plan
and intent; had initiated or modified antidepressant pharmacotherapy in the previous 14
days; or had used any IntelliCare app more than one time in the three months prior to study
screening.