NCT00669526

Brief Summary

This project assesses the clinical and cost effectiveness of brief cognitive-behavioral therapy (CBT) for depressed (ages 11-17) and anxious (ages 8-17) youths seen for services in pediatric primary care. This study is designed to compare the impact of brief CBT delivered on-site in pediatric primary care to referral to specialty mental health care (SMHC), as well as obtain an estimate of the total costs of the CBT protocols for depression and anxiety and the cost-effectiveness of the protocols compared to referral to and utilization of SMHC services.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
60

participants targeted

Target at P25-P50 for phase_2 depression

Timeline
Completed

Started Oct 2004

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

October 1, 2004

Completed
2.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2007

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

April 1, 2007

Completed
1.1 years until next milestone

First Submitted

Initial submission to the registry

April 28, 2008

Completed
2 days until next milestone

First Posted

Study publicly available on registry

April 30, 2008

Completed
Last Updated

April 30, 2008

Status Verified

April 1, 2008

Enrollment Period

2.4 years

First QC Date

April 28, 2008

Last Update Submit

April 29, 2008

Conditions

Keywords

anxietydepressionMajor Depressive DisorderchildadolescentCBTCognitive-Behavioral Therapyprimary care

Outcome Measures

Primary Outcomes (1)

  • Clinician Global Impressions - Improvement (CGI-I)

    weeks 12 and 24

Study Arms (2)

SMHC referral

ACTIVE COMPARATOR

Referral to local Specialty Mental Health Care Services

Behavioral: SMHC referral

BCBT

EXPERIMENTAL

Brief Cognitive Behavioral Therapy

Behavioral: BCBT

Interventions

BCBTBEHAVIORAL

Brief Cognitive Behavioral Therapy. This BCBT protocol consists of up to 8 CBT sessions to be conducted over a maximum of 12 weeks.

Also known as: CBT, Cognitive-Behavioral Therapy
BCBT
SMHC referralBEHAVIORAL

Referral to local Speciality Mental Health Care. Families were referred to local mental health care providers, and could freely choose any treatment or combination of treatments offered (e.g., anti-depressant medication, individual psychotherapy, family psychotherapy, etc.).

SMHC referral

Eligibility Criteria

Age7 Years - 17 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17)

You may qualify if:

  • Ages 11 to 17 years
  • Meet diagnostic criteria for Major Depression, Dysthymia, or Minor Depression
  • Live with a legal guardian
  • Ages 7 to 17 years
  • Meet full or probable (missing one, non-core symptom) diagnostic criteria for Separation Anxiety Disorder, Generalized Anxiety Disorder, Social Phobia, or Specific Phobia
  • Live with a legal guardian

You may not qualify if:

  • Require treatment other than brief CBT (namely, youths with bipolar disorder, psychosis, active suicidal ideation with plan, post-traumatic stress disorder, substance dependence, or mental retardation
  • Experience of recent physical or sexual maltreatment
  • Serious or unstable physical illness
  • Current participation in an alternate, active intervention for the target condition of interest

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of Pittsburgh Medical Center

Pittsburgh, Pennsylvania, 15213, United States

Location

Related Publications (1)

  • Weersing, V. R., Gonzalez, A., Campo, J. V., & Lucas, A. N. Brief Behavioral Therapy for Pediatric Anxiety and Depression: Piloting an Integrated Treatment Approach. Cognitive and Behavioral Practice (in press), 2008.

    BACKGROUND

Related Links

MeSH Terms

Conditions

DepressionAnxiety DisordersDepressive Disorder, Major

Interventions

Cognitive Behavioral Therapy

Condition Hierarchy (Ancestors)

Behavioral SymptomsBehaviorMental DisordersDepressive DisorderMood Disorders

Intervention Hierarchy (Ancestors)

Behavior TherapyPsychotherapyBehavioral Disciplines and Activities

Study Officials

  • V. Robin Weersing, Ph.D.

    SDSU/UCSD Joint Doctoral Program in Clinical Psychology

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER

Study Record Dates

First Submitted

April 28, 2008

First Posted

April 30, 2008

Study Start

October 1, 2004

Primary Completion

March 1, 2007

Study Completion

April 1, 2007

Last Updated

April 30, 2008

Record last verified: 2008-04

Locations