A Closed-loop Assessment and Treatment Platform for Unipolar Depression and Anxiety
This study is a validation study to evaluate the acceptability and feasibility of the closed-loop strategy employing the mobile mental health application with the target population to prepare for a large-scale efficacy trial in adults with MDD, depression and/or anxiety.
1. Participant must be 18 to 60 years of age.
2. Participant must score ≥ 9 on the Patient Health Questionnaire-9 (PHQ-9).
3. Participant taking antidepressants or engaged in psychotherapy will not be excluded.
If potential participants are currently prescribed psychotropic medication, they must
be on a clinically stable medication regimen for ≥ 6 weeks prior to screening, based
on self-report or as verified by medical health records, when available and
4. Participant must be a fluent English speaker.
5. 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
6. Participant must have access to wireless Internet connectivity.
7. Participant must be willing to communicate with study staff via email.
1. Participant with unstable and/or untreated conditions that may affect cognition,
including untreated substance abuse/dependence disorders, unmanaged cardiovascular
disease, endocrine or neurologic disorder, epilepsy, brain injury, hospitalization
within 6-weeks of enrollment, ongoing chemotherapy or other cancer treatment (e.g.,
2. Participant with history or current DSM-5 diagnosis of psychosis, such as
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 less than a
14 (75%) on the UBACC.
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, are likely to present significant problems for the
staff conducting assessments.
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
8. Participant is using computer-based cognitive training programs or has used it within
a month of the consent date.