Clinical trial NCT01582581: Study of Technology-assisted Treatment of Adolescent Depression
Official title: Information Technology Enabled Treatment of Adolescent Depression
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Major Depressive Disorder
Keywords: mental health
depression
behavioral health
cognitive behavioral therapy
CBT
computer-assisted psychotherapy
Lead sponsor: iHope Network, Inc.
Sponsor class: INDUSTRY
Collaborators: name: Woburn Pediatric Associates
name: UConn Health
First posted: 2012-04-20
Enrollment: 45
Sex: ALL
Minimum age (years): 12
Maximum age (years): 17
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief 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.

Eligibility criteria: 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)

Primary outcomes:
measure: Changes in measures of depression over the course of treatment among teens with Major Depressive Disorder.
timeFrame: 12 weeks
Secondary outcomes:
measure: Evidence of program efficacy as indicate by changes in subjects' knowledge of depression.
timeFrame: 12 weeks
measure: Evidence of program efficacy as indicated by development of self-efficacy skills.
timeFrame: 12 weeks
measure: Evidence of program efficacy as indicated by the establishment of therapeutic alliance.
timeFrame: 12weeks
measure: Evidence of program efficacy as indicated by fidelity and treatment quality.
timeFrame: 12 weeks
measure: Evidence of program efficacy as indicated by program acceptance.
timeFrame: 12 weeks
Other outcomes:
Locations:
city: Farmington
country: United States
facility: University of Connecticut Health Center
state: Connecticut
city: Woburn
country: United States
facility: Woburn Pediatric Associates
state: Massachusetts
Study officials:
affiliation: iHope Network, Inc.
name: Steven E Locke, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: iHope Network, Inc.
name: Thomas J. McLaughlin, ScD
role: PRINCIPAL_INVESTIGATOR
References: