Clinical and Cost Effectiveness of Brief Cognitive-Behavioral Therapy (CBT) for Pediatric Internalizing Disorders
April 29, 2008 updated by: Robert Wood Johnson Foundation
Clinical and Cost Effectiveness of Brief CBT for Pediatric Internalizing Disorders
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.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Study Type
Interventional
Enrollment (Actual)
60
Phase
- Phase 2
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
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Pennsylvania
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Pittsburgh, Pennsylvania, United States, 15213
- University of Pittsburgh Medical Center
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Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
7 years to 17 years (Child)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
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
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
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Active Comparator: SMHC referral
Referral to local Specialty Mental Health Care Services
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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.).
|
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Experimental: BCBT
Brief Cognitive Behavioral Therapy
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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:
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
|---|---|
|
Clinician Global Impressions - Improvement (CGI-I)
Time Frame: weeks 12 and 24
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weeks 12 and 24
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Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Principal Investigator: V. Robin Weersing, Ph.D., SDSU/UCSD Joint Doctoral Program in Clinical Psychology
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
General 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.
Helpful Links
- The National Institute of Mental Health (NIMH) is the largest scientific organization in the world dedicated to research focused on the understanding, treatment, and prevention of mental disorders and the promotion of mental health.
- The Robert Wood Johnson Foundation (RWJF) focuses on the pressing health and health care issues facing our country.
- William T. Grant Foundation's mission focuses on improving the lives of youth ages 8 to 25 in the United States. We accomplish this by providing grants primarily for high-quality empirical studies.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
October 1, 2004
Primary Completion (Actual)
March 1, 2007
Study Completion (Actual)
April 1, 2007
Study Registration Dates
First Submitted
April 28, 2008
First Submitted That Met QC Criteria
April 29, 2008
First Posted (Estimate)
April 30, 2008
Study Record Updates
Last Update Posted (Estimate)
April 30, 2008
Last Update Submitted That Met QC Criteria
April 29, 2008
Last Verified
April 1, 2008
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- 051653
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.