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

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.

We are developing an intelligent treatment system 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 pilot study, 200 participants with Major Depression and/or Anxiety will use
Intellicare apps for up to 8 weeks and may be invited to provide feedback about their
experience at two follow-up time points: weeks 4 and 8. 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. Each week, participants will receive a brief motivational intervention from a
coach. This coach will also be available to participants via email throughout the 8 week
study. We will use data from the pilot study to examine whether IntelliCare is a feasible and
effective intervention. Data collected will also be used to develop and evaluate machine
learning methods which will be used in the subsequent AIM trials.

Inclusion Criteria:

- Meets criteria for clinically significant symptoms of depression or anxiety using
self-report measures used in screening for depression, as well as interviewer
administered measures to ensure symptoms are not transitory and have been present for
at least two weeks.

- Is familiar with the use of mobile phones

- Has an Android phone and is willing download the IntelliCare apps on their own device

- Is able to speak and read English

- Is at least 19 years of age

- Is able to give informed consent

Exclusion Criteria:

- Has visual, hearing, voice, or motor impairment that would prevent completion of study
and treatment procedures

- Has any psychiatric condition for which participation in a clinical trial of
psychotherapy may be either inappropriate or dangerous (e.g., psychotic disorders,
bipolar disorders, dissociative disorders, obsessive compulsive disorder, severe post
traumatic stress disorder, etc.).

- Exhibits severe suicidality, including ideation, plan, and intent.

- Currently receiving psychotherapy or planning to receive psychotherapy during the 8
weeks of the study.

- Participants who have been on an antidepressant or anxiolytic medication with no dose
changes for 2 weeks and do not intend to change the dose will be eligible. Those who
have been on the antidepressant or anxiolytic for less than 2 weeks or intend to have
their medication optimized will be asked to wait for screening until they meet the
2-week criterion.