Study of Technology-assisted Treatment of Adolescent Depression

NCT01582581 | Completed DMC

• 1 other identifier: VHS 85350-02
• Study Type: interventional
• Target: 45
• Locations: 1 country
• Sites: 2

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.

Conditions

Major Depressive Disorder

Keywords

mental health; depression; behavioral health; cognitive behavioral therapy; CBT; computer-assisted psychotherapy

Outcome Measures

Primary Outcomes (1)

• Changes in measures of depression over the course of treatment among teens with Major Depressive Disorder.

  The measure used is the PHQ-9 (Kroenke, et al.), a standard and validated measure for use in screening for or monitoring adolescent depression. Teens that score positively on Item #9 (a self-harm risk item), will be further evaluated by the clinician using two interactive and validated methods for standardized assessment of suicide risk: a brief version of the Beck Hopelessness scale and the C-CASA (Columbia University). Teens needing referral to a behavioral health specialist will be referred by the nurse and/or the pediatrician for further evaluation and treatment.

  12 weeks

Secondary Outcomes (5)

• Evidence of program efficacy as indicate by changes in subjects' knowledge of depression.

  12 weeks

• Evidence of program efficacy as indicated by development of self-efficacy skills.

  12 weeks

• Evidence of program efficacy as indicated by the establishment of therapeutic alliance.

  12weeks

• Evidence of program efficacy as indicated by fidelity and treatment quality.

  12 weeks

• Evidence of program efficacy as indicated by program acceptance.

  12 weeks

Study Arms (2)

Telephonic CBT

ACTIVE COMPARATOR

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

Behavioral: Telephonic CBT

Wait List Control

SHAM COMPARATOR

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

Behavioral: Wait List Control

Interventions

Telephonic CBT 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.

Also known as: iTAD, ITEMS-TAD, Computer-guided CBT, TAD

Telephonic CBT

Wait List Control BEHAVIORAL

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

Wait List Control

Eligibility Criteria

• Age: 12 Years - 17 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• 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

You may not qualify if:

• 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)

Sponsors & Collaborators

• iHope Network, Inc.: lead
• Woburn Pediatric Associates: collaborator
• UConn Health: collaborator

Study Sites (2)

University of Connecticut Health Center

Farmington, Connecticut, 06030, United States

Location

Woburn Pediatric Associates

Woburn, Massachusetts, 01801, United States

Location

MeSH Terms

Conditions

Depressive Disorder, Major; Psychological Well-Being; Depression

Condition Hierarchy (Ancestors)

Depressive Disorder; Mood Disorders; Mental Disorders; Personal Satisfaction; Behavior; Behavioral Symptoms

Study Officials

• Steven E Locke, MD

  iHope Network, Inc.

  PRINCIPAL INVESTIGATOR

• Thomas J. McLaughlin, ScD

  iHope Network, Inc.

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 19, 2012
• First Posted: April 20, 2012
• Study Start: March 1, 2012
• Primary Completion: December 1, 2014
• Study Completion: December 1, 2014
• Last Updated: April 30, 2015

Record last verified: 2015-04

Locations

US (2)