Study of Technology-assisted Treatment of Adolescent Depression
Condition: Major Depressive Disorder
MeSH terms: Depression; Depressive Disorder; Depressive Disorder, Major
Study type: Interventional

Summary: 
      The purpose of this study is to evaluate a computer-guided, telephone-based therapy for
      adolescent depression, delivered in a pediatric primary setting in the community.
    

Detailed description: 
      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.
    

Intervention name(s): Telephonic CBT; Wait List Control
Intervention type(s): Behavioral; Behavioral
Intervention description(s): Cognitive behavioral therapy, guided by computer, using the TAD protocol for treatment of Adolescent Depression, modified for delivery by a nurse or master's level clinician over the telephone in 15-18 sessions lasting 30-45 minutes at weekly intervals. Includes regular and standardized weekly monitoring by the treating clinician of depressive symptoms and factors affecting suicide risk.; Wait list control with measurement of key outcomes at baseline (week 0), and then weeks 3 and 5.
Other intervention name(s): iTAD; ITEMS-TAD; Computer-guided CBT; TAD
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Participant)
Primary purpose: Treatment
Keywords: mental health; depression; behavioral health; cognitive behavioral therapy; CBT; computer-assisted psychotherapy