Study of Technology-assisted Treatment of Adolescent Depression

NCT ID: NCT01582581

Last Updated: 2015-04-30

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 45 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2012-03-31
• Study Completion Date: 2014-12-31

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.

Conditions

Major Depressive Disorder

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

Telephonic CBT

Computer guided, cognitive behavioral therapy (CBT) delivered by a clinician-administered telephone intervention.

Group Type: ACTIVE_COMPARATOR

Telephonic CBT

Intervention Type: BEHAVIORAL

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

Randomized wait list control with measurement of study outcomes at week 0, 3 and 5 after the initiation of waiting.

Group Type: SHAM_COMPARATOR

Wait List Control

Intervention Type: BEHAVIORAL

Wait list control with measurement of key outcomes at baseline (week 0), and then weeks 3 and 5.

Interventions

Telephonic CBT

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.

Intervention Type: BEHAVIORAL

Wait List Control

Wait list control with measurement of key outcomes at baseline (week 0), and then weeks 3 and 5.

Intervention Type: BEHAVIORAL

Other Intervention Names

iTAD; ITEMS-TAD; Computer-guided CBT; TAD

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)

• Minimum Eligible Age: 12 Years
• Maximum Eligible Age: 17 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Woburn Pediatric Associates

UNKNOWN

Sponsor Role: collaborator

UConn Health

OTHER

Sponsor Role: collaborator

iHope Network, Inc.

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Steven E Locke, MD

Role: PRINCIPAL_INVESTIGATOR

iHope Network, Inc.

Thomas J. McLaughlin, ScD

Role: PRINCIPAL_INVESTIGATOR

iHope Network, Inc.

Locations

University of Connecticut Health Center

Farmington, Connecticut, United States

Woburn Pediatric Associates

Woburn, Massachusetts, United States

Countries

United States

Other Identifiers

VHS 85350-02

Identifier Type: -

Identifier Source: org_study_id