Clinical and Cost Effectiveness of Brief Cognitive-Behavioral Therapy (CBT) for Pediatric Internalizing Disorders

This study has been completed.
Sponsor:
Collaborators:
William T. Grant Foundation
Information provided by:
Robert Wood Johnson Foundation
ClinicalTrials.gov Identifier:
NCT00669526
First received: April 28, 2008
Last updated: April 29, 2008
Last verified: April 2008
  Purpose

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.


Condition Intervention Phase
Depression
Anxiety
Behavioral: BCBT
Behavioral: SMHC referral
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Clinical and Cost Effectiveness of Brief CBT for Pediatric Internalizing Disorders

Resource links provided by NLM:


Further study details as provided by Robert Wood Johnson Foundation:

Primary Outcome Measures:
  • Clinician Global Impressions - Improvement (CGI-I) [ Time Frame: weeks 12 and 24 ] [ Designated as safety issue: No ]

Enrollment: 60
Study Start Date: October 2004
Study Completion Date: April 2007
Primary Completion Date: March 2007 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: SMHC referral
Referral to local Specialty Mental Health Care Services
Behavioral: SMHC referral
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.).
Experimental: BCBT
Brief Cognitive Behavioral Therapy
Behavioral: BCBT
Brief Cognitive Behavioral Therapy. This BCBT protocol consists of up to 8 CBT sessions to be conducted over a maximum of 12 weeks.
Other Names:
  • CBT
  • Cognitive-Behavioral Therapy

  Eligibility

Ages Eligible for Study:   7 Years to 17 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria for depression:

  • Ages 11 to 17 years
  • Meet diagnostic criteria for Major Depression, Dysthymia, or Minor Depression
  • Live with a legal guardian

Inclusion Criteria for anxiety:

  • 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

Exclusion Criteria:

  • 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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00669526

Locations
United States, Pennsylvania
University of Pittsburgh Medical Center
Pittsburgh, Pennsylvania, United States, 15213
Sponsors and Collaborators
Robert Wood Johnson Foundation
William T. Grant Foundation
Investigators
Principal Investigator: V. Robin Weersing, Ph.D. SDSU/UCSD Joint Doctoral Program in Clinical Psychology
  More Information

Additional Information:
Publications:
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.

Responsible Party: V. Robin Weersing, Ph.D. / Principal Investigator, SDSU/UCSD Joint Doctoral Program in Clinical Psychology
ClinicalTrials.gov Identifier: NCT00669526     History of Changes
Other Study ID Numbers: 051653
Study First Received: April 28, 2008
Last Updated: April 29, 2008
Health Authority: United States: Institutional Review Board

Keywords provided by Robert Wood Johnson Foundation:
anxiety
depression
Major Depressive Disorder
child
adolescent
CBT
Cognitive-Behavioral Therapy
primary care

Additional relevant MeSH terms:
Depression
Depressive Disorder
Behavioral Symptoms
Mood Disorders
Mental Disorders

ClinicalTrials.gov processed this record on September 29, 2014