Study of Technology-assisted Treatment of Adolescent Depression (iTAD)

iHope Network, Inc.

Status

Completed

Conditions

Major Depressive Disorder

Treatments

Behavioral: Telephonic CBT

Behavioral: Wait List Control

Study type

Interventional

Funder types

Other

Industry

Identifiers

NCT01582581

VHS 85350-02

Details and patient eligibility

About

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.

Full 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.

Enrollment

45 patients

Sex

All

Ages

12 to 17 years old

Volunteers

No Healthy Volunteers

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)