Study of Technology-assisted Treatment of Adolescent Depression

This Phase II SBIR project represents the continuing development of an Information
Technology Enabled Disease Management System for Treatment of Adolescent Depression (iTAD)
following a highly successful Phase I award in which all Specific Aims were met. The need
for this system innovation arises from the substantial costs that inadequately treated
adolescent Major Depressive Disorder (MDD) has on the course of adolescent development and
society as a whole. Effective treatments involving the combined use of a Selective Serotonin
Reuptake Inhibitor (SSRI) and the administration of Cognitive Behavioral Therapy (CBT) is
considered the "modal treatment" for adolescent MM. Yet, multiple barriers interfere with
the implementation and dissemination of this "gold standard' of care. These barriers
include: under recognition of depressive symptoms by parents and pediatricians, inability to
assess adolescent depression accurately and reliably in primary care settings, safety
concerns related to pharmacologic treatment, monitoring of symptom changes and adverse
treatment effects, such as irritability and suicidal behavior, treatment non-compliance,
lack of access to an integrated medical and treatment history; and an alarming shortage of
properly trained child and adolescent psychiatrists capable of implementing optimal
treatment safely, reliably, and effectively.

In this current project, the investigators are making tailored forms of CBT broadly and
easily accessible to the community, using the iTAD (previously "ITEMS-TAD") which is
intended to address these problems. Development of the system has continued and we have
modified the existing prototype that was created with funding from federal sources (Phase
1). The technological infrastructure of the prototype includes a Computer Assisted Telephone
Interview (CATI) platform, a database consisting of patients' real time medical and
treatment history, and an underlying set of intelligent algorithms that tailors the
intensity of the treatment resources and approaches administered in individual cases, with a
special focus on identifying those enrolled adolescents needing more intensive or urgent
care. When interacting with patients over the telephone, primary care nurses use the CATI to
facilitate the reliable assessment of patient status and administer manualized, empirically
informed interventions. The programming for the platform that delivers this intervention is
complete and the debugging and refinement underway. The content for the remaining iTAD
program has been developed and is being programmed. A Rapid Iterative Evaluation & Testing
(RITE) study was undertaken to refine the content of the application and assess the
usability of the technology involved in its delivery; A field trial is underway to evaluate
empirically indicators of efficacy and patient acceptance related to the ITEMS-TAD approach.
The clinical trial of iTAD will begin in early April 2012. The investigators are currently
enrolling depressed adolescents who will begin the trial shortly.

Inclusion Criteria:

- Diagnosis of Major Depressive Disorder

- Age 12-17 years, inclusive, at time of first study visit

- Ability to receive care as an outpatient

- Ability to participate in at least 1 session by phone per week for approximately 12
weeks

- Ability to participate in at least 1 session by phone per week for approximately
12-16 weeks

- Ability to speak English fluently and to provide written and/or verbal feedback on
the instrument and the process.

- Pediatrician impression of normal IQ for developmental level

Exclusion Criteria:

- Current or past diagnosis of: bipolar disorder, severe conduct disorder, pervasive
developmental disorders, of thought disorder

- Current treatment with Cognitive Behavioral Therapy (CBT)

- Confounding medical condition (such as pregnancy, Lyme disease, etc.)

- Non-English speaking patient or parent/guardian

- No access to phones

- Dangerousness to self or others if they have been hospitalized for dangerousness
within three months of consent

- Deemed to be "high risk" because of a suicide attempt requiring medical attention
within 6 months of consent or clear intent or an active plan to commit suicide

- History of self-harm, suicidal attempts, or suicidal ideation

- Specialty care for substance abuse (i.e. without participation of primary care
providers)