Brief Cognitive Behavioral Therapy (CBT) for Pediatric Anxiety and Depression in Primary Care (BCBT-PC)

April 12, 2016 updated by: V. Robin Weersing, San Diego State University

Brief CBT for Pediatric Anxiety and Depression in Primary Care

The purpose of this study is to determine whether a brief (12 week) psychological treatment program, based in primary care, can help youths struggling with anxiety and/or depression. This brief cognitive behavioral therapy program will be compared to enhanced referral to specialty mental health care.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

Mood and anxiety disorders in childhood and adolescence are disabling, distressing, and prevalent and produce added costs to health systems. This two-site randomized controlled trial will test the effects of a brief cognitive behavioral therapy (BCBT) protocol (8-12 sessions) in a large sample (N=210) of children and adolescents (age 8-16) presenting with anxiety and/or depression in primary care. Clinical and cost-effectiveness of BCBT will be compared to a plausible public health alternative - enhanced referral to specialty mental health care (SMHC). This investigation is noteworthy in adopting a deployment-focused model and testing this intervention early in its development within a real world context (primary care) and against a plausible public health comparison condition (SMHC) relevant for future treatment dissemination.

Study Type

Interventional

Enrollment (Actual)

185

Phase

  • Not Applicable

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

  • United States
    • California
      • San Diego, California, United States, 92120
        • San Diego State University
    • Pennsylvania
      • Pittsburgh, Pennsylvania, United States, 15213
        • Western Psychiatric Institute and Clinics

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

8 years to 16 years (Child)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • meet full or probable diagnostic criteria for Separation Anxiety Disorder, Generalized Anxiety Disorder, Social Phobia, Major Depression, Dysthymic Disorder, or Minor Depression
  • age 8.0 to 16.9
  • live with legal, consenting guardian for at least 6 months

Exclusion Criteria:

  • youths requiring alternate intervention (e.g., youths with bipolar disorder, psychosis, active suicidal ideation with plan, PTSD, substance dependence, current physical or sexual abuse, or mental retardation
  • suffer from serious or unstable physical illness (e.g., uncontrolled diabetes)
  • currently in active, alternate intervention for anxiety or depression (e.g., antidepressant use)

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
Active Comparator: specialty mental health care referral
Behavioral: Specialty mental health care referral (SMHC)
SMHC: specialty mental health care referrals provided
Other Names:
  • SMHC
Experimental: Brief Cognitive Behavioral Therapy
Behavioral: Brief Cognitive Behavioral Therapy (BCBT)
BCBT: 8-12 sessions over 16 weeks of cognitive-behavioral therapy administered by Master's-level clinicians in primary care setting
Other Names:
  • BCBT

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Clinical Global Impression
Time Frame: measured at baseline (week 0)
measured at baseline (week 0)
Clinical Global Impression
Time Frame: measured at post-treatment (week 16)
measured at post-treatment (week 16)
Clinical Global Impression
Time Frame: measured at 8 month follow-up (week 32)
measured at 8 month follow-up (week 32)

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Pediatric Anxiety Rating Scale
Time Frame: measured at baseline (week 0)
measured at baseline (week 0)
Children's Depression Rating Scale - Revised
Time Frame: measured at baseline (week 0)
measured at baseline (week 0)
Health Utilities Index
Time Frame: measured at baseline (week 0)
This measure will aid in cost-effectiveness analyses.
measured at baseline (week 0)
Pediatric Anxiety Rating Scale
Time Frame: measured at post-treatment (week 16)
measured at post-treatment (week 16)
Pediatric Anxiety Rating Scale
Time Frame: measured at 8 month follow-up (week 32)
measured at 8 month follow-up (week 32)
Children's Depression Rating Scale - Revised
Time Frame: measured at post-treatment (week 16)
measured at post-treatment (week 16)
Children's Depression Rating Scale - Revised
Time Frame: measured at 8 month follow-up (week 32)
measured at 8 month follow-up (week 32)
Health Utilities Index
Time Frame: measured at post-treatment (week 16)
This measure will aid in cost-effectiveness analyses.
measured at post-treatment (week 16)
Health Utilities Index
Time Frame: measured at 8 month follow-up (week 32)
This measure will aid in cost-effectiveness analyses.
measured at 8 month follow-up (week 32)

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

San Diego State University

Collaborators

National Institute of Mental Health (NIMH)
University of Pittsburgh
Kaiser Permanente

Investigators

  • Principal Investigator: V. Robin Weersing, Ph.D., San Diego State University
  • Principal Investigator: David A Brent, M.D., Western Psychiatric Institute and Clinics

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

Helpful Links

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

September 1, 2010

Primary Completion (Actual)

April 1, 2016

Study Completion (Actual)

April 1, 2016

Study Registration Dates

First Submitted

June 17, 2010

First Submitted That Met QC Criteria

June 21, 2010

First Posted (Estimate)

June 22, 2010

Study Record Updates

Last Update Posted (Estimate)

April 14, 2016

Last Update Submitted That Met QC Criteria

April 12, 2016

Last Verified

April 1, 2016

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 7887933
  • 5R01MH084935 (U.S. NIH Grant/Contract)

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.

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