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

This study has been completed.

Sponsor:

Collaborators:

National Institute of Mental Health (NIMH)

William T. Grant Foundation (WTGF)

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

History of Changes

Tracking Information

First Received Date ^ICMJE

April 28, 2008

Last Updated Date

April 29, 2008

Start Date ^ICMJE

October 2004

Primary Completion Date

March 2007 (final data collection date for primary outcome measure)

Current Primary Outcome Measures ^ICMJE

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

Original Primary Outcome Measures ^ICMJE

Same as current

Change History

Complete list of historical versions of study NCT00669526 on ClinicalTrials.gov Archive Site

Current Secondary Outcome Measures ^ICMJE

Original Secondary Outcome Measures ^ICMJE

Current Other Outcome Measures ^ICMJE

Original Other Outcome Measures ^ICMJE

Descriptive Information

Brief Title ^ICMJE

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

Official Title ^ICMJE

Clinical and Cost Effectiveness of Brief CBT for Pediatric Internalizing Disorders

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.

Detailed Description

Study Type ^ICMJE

Interventional

Study Phase

Phase 2

Study Design ^ICMJE

Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Outcomes Assessor)
Primary Purpose: Treatment

Condition ^ICMJE

Depression
Anxiety

Intervention ^ICMJE

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
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.).

Study Arm (s)

Active Comparator: SMHC referral
Referral to local Specialty Mental Health Care Services

Intervention: Behavioral: SMHC referral
Experimental: BCBT
Brief Cognitive Behavioral Therapy

Intervention: Behavioral: BCBT

Publications *

* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.

Recruitment Information

Recruitment Status ^ICMJE

Completed

Enrollment ^ICMJE

Completion Date

April 2007

Primary Completion Date

March 2007 (final data collection date for primary outcome measure)

Eligibility Criteria ^ICMJE

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

Gender

Both

Ages

7 Years to 17 Years

Accepts Healthy Volunteers

Contacts ^ICMJE

Contact information is only displayed when the study is recruiting subjects

Location Countries ^ICMJE

United States

Administrative Information

NCT Number ^ICMJE

NCT00669526

Other Study ID Numbers ^ICMJE

051653

Has Data Monitoring Committee

Responsible Party

V. Robin Weersing, Ph.D. / Principal Investigator, SDSU/UCSD Joint Doctoral Program in Clinical Psychology

Study Sponsor ^ICMJE

Robert Wood Johnson Foundation

Collaborators ^ICMJE

National Institute of Mental Health (NIMH)
William T. Grant Foundation (WTGF)

Investigators ^ICMJE

Principal Investigator:

V. Robin Weersing, Ph.D.

SDSU/UCSD Joint Doctoral Program in Clinical Psychology

Information Provided By

Robert Wood Johnson Foundation

Verification Date

April 2008

^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP

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