A Closed-loop Assessment and Treatment Platform for Mood Disorders

Specific Aim 1: Investigators have recently constructed a beta version of the MMT
application, comprised of the multi-modal assessment modules, several treatment modules and
an initial version of the closed-loop algorithm to control treatment delivery. Utilizing the
extensive experience in developing mobile assessment and treatment tools at Posit Science
Corporation, the investigators will employ an iterative development process incorporating
feedback from users (focus groups of patients with mood disorders), clinicians and scientists
(project consultants) to achieve the following development goals: (1) Finalize MMT's
closed-loop algorithm to incorporate all assessment modules and expand the existing triage
approach; (2) Expand cognitive behavioral therapy (CBT) functions within the app; and (3)
Expand in-app bi-directional communication feature between the clinician and user. At the
completion of Specific Aim 1, the investigators will have a mobile app suitable for
evaluation in a feasibility trial (Specific Aim 2).

Specific Aim 2: The investigators will conduct a single arm, open label feasibility field
trial with 30 participants that meet criteria for Major Depressive Disorder (MDD).
Participants will be asked to engage with the experimental cognitive treatment and spend up
to six weeks engaged in 15 hours of cognitive training as an adjunct to their standard
clinical treatment. The experimental cognitive treatment will be deployed as dictated by the
closed loop predictive algorithm, with all patient data continuously accessible for remote
monitoring by the attending clinicians, research staff and Principal Investigator at
University of Minnesota, and research staff and Sponsor PI at Posit Science Corporation.
Participants will be re-evaluated every two weeks during treatment use, and again at the
expected time of completion of training, at 6 weeks, to evaluate changes in cognitive
function. Participants will then stop using their assigned program for 6 weeks, and return
for a follow-up assessment to evaluate the endurance of changes in cognitive function in the
absence of further program use.

Inclusion Criteria:

1. Participants must be 18 to 60 years of age.

2. Participant must be referred by a clinician and is currently in treatment for
depression and/or anxiety, as verified by the attending clinician. Other comorbid
psychiatric conditions will be verified by the attending clinician.

3. Participants taking antidepressants or engaged in psychotherapy will not be excluded;
instead, their antidepressant treatment will be evaluated and entered as covariates in
all statistical analyses. However, participants on antidepressants, anxiolytics, etc.
must be on a stable medication regimen ≥ 6 weeks prior to screening.

4. Participants must be clinically stable and on out-patient status for a period of ≥ 6
weeks prior to screening.

5. Participant must be a fluent English speaker.

6. Participant must have adequate sensorimotor capacity to perform the program, including
visual capacity adequate to read from a computer screen at a normal viewing distance,
auditory capacity adequate to understand normal speech, and motor capacity adequate to
control and use a mobile device and/or computer as required to complete study
activities.

7. Participant must have access to wireless Internet connectivity.

8. Participants must be willing to communicate with study staff via email.

Exclusion Criteria:

1. Participants with unstable and/or untreated conditions that may affect cognition,
including substance abuse/dependence disorders, cardiovascular, endocrine, neurologic
disorder, epilepsy, brain injury, recent hospitalization, ongoing chemotherapy or
other cancer treatment

2. Per clinician report, participants with history or current DSM-5 diagnosis of organic
mental disorder, schizophrenia, schizoaffective disorder, delusion disorder, psychotic
disorder NOS, bipolar disorder, substance abuse (<1 year), and/or mood congruent or
mood incongruent psychotic features or disorders.

3. Participant has a history or current diagnosis of dementia and/or scores within an
abnormal range on the UBACC, at the time of screening.

4. Participant with active suicidal ideations or behaviors within 2 months of screening

5. Participant that shows signs of intoxication due to current substance abuse (including
alcohol and/or illegal drugs) during any in person visit. Such participants will have
that visit re-scheduled; participants with this problem occurring more than once may
be excluded and dropped at the discretion of the Principal Investigators.

6. Participant has problems performing assessments or comprehending or following spoken
instructions, or those with behaviors during screening or baseline visits that, in the
judgment of the screening staff.

7. Participant is enrolled in a concurrent clinical trial involving an investigational
pharmaceutical, nutraceutical, medical device, or behavioral treatment that could
affect the outcome of this study. However, participation in standard treatments (e.g.,
occupational therapy) or use of prescribed medications (e.g., anti-depressants) is
allowable.

8. Participant is using computer-based cognitive training programs or has used it within
a month of the consent date.