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

Primary Purpose

Anxiety, Depression

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Brief Cognitive Behavioral Therapy (BCBT)
Specialty mental health care referral (SMHC)
Sponsored by
San Diego State University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Anxiety focused on measuring Child, adolescent, anxiety, depression, internalizing, cognitive behavioral therapy, pediatric primary care

Eligibility Criteria

8 Years - 16 Years (Child)All SexesDoes not accept healthy volunteers

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)

Sites / Locations

  • San Diego State University
  • Western Psychiatric Institute and Clinics

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Experimental

Arm Label

specialty mental health care referral

Brief Cognitive Behavioral Therapy

Arm Description

Outcomes

Primary Outcome Measures

Clinical Global Impression
Clinical Global Impression
Clinical Global Impression

Secondary Outcome Measures

Pediatric Anxiety Rating Scale
Children's Depression Rating Scale - Revised
Health Utilities Index
This measure will aid in cost-effectiveness analyses.
Pediatric Anxiety Rating Scale
Pediatric Anxiety Rating Scale
Children's Depression Rating Scale - Revised
Children's Depression Rating Scale - Revised
Health Utilities Index
This measure will aid in cost-effectiveness analyses.
Health Utilities Index
This measure will aid in cost-effectiveness analyses.

Full Information

First Posted
June 17, 2010
Last Updated
April 12, 2016
Sponsor
San Diego State University
Collaborators
University of Pittsburgh, Kaiser Permanente, National Institute of Mental Health (NIMH)
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1. Study Identification

Unique Protocol Identification Number
NCT01147614
Brief Title
Brief Cognitive Behavioral Therapy (CBT) for Pediatric Anxiety and Depression in Primary Care
Acronym
BCBT-PC
Official Title
Brief CBT for Pediatric Anxiety and Depression in Primary Care
Study Type
Interventional

2. Study Status

Record Verification Date
April 2016
Overall Recruitment Status
Completed
Study Start Date
September 2010 (undefined)
Primary Completion Date
April 2016 (Actual)
Study Completion Date
April 2016 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
San Diego State University
Collaborators
University of Pittsburgh, Kaiser Permanente, National Institute of Mental Health (NIMH)

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

Brief Summary
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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Anxiety, Depression
Keywords
Child, adolescent, anxiety, depression, internalizing, cognitive behavioral therapy, pediatric primary care

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
185 (Actual)

8. Arms, Groups, and Interventions

Arm Title
specialty mental health care referral
Arm Type
Active Comparator
Arm Title
Brief Cognitive Behavioral Therapy
Arm Type
Experimental
Intervention Type
Behavioral
Intervention Name(s)
Brief Cognitive Behavioral Therapy (BCBT)
Other Intervention Name(s)
BCBT
Intervention Description
BCBT: 8-12 sessions over 16 weeks of cognitive-behavioral therapy administered by Master's-level clinicians in primary care setting
Intervention Type
Behavioral
Intervention Name(s)
Specialty mental health care referral (SMHC)
Other Intervention Name(s)
SMHC
Intervention Description
SMHC: specialty mental health care referrals provided
Primary Outcome Measure Information:
Title
Clinical Global Impression
Time Frame
measured at baseline (week 0)
Title
Clinical Global Impression
Time Frame
measured at post-treatment (week 16)
Title
Clinical Global Impression
Time Frame
measured at 8 month follow-up (week 32)
Secondary Outcome Measure Information:
Title
Pediatric Anxiety Rating Scale
Time Frame
measured at baseline (week 0)
Title
Children's Depression Rating Scale - Revised
Time Frame
measured at baseline (week 0)
Title
Health Utilities Index
Description
This measure will aid in cost-effectiveness analyses.
Time Frame
measured at baseline (week 0)
Title
Pediatric Anxiety Rating Scale
Time Frame
measured at post-treatment (week 16)
Title
Pediatric Anxiety Rating Scale
Time Frame
measured at 8 month follow-up (week 32)
Title
Children's Depression Rating Scale - Revised
Time Frame
measured at post-treatment (week 16)
Title
Children's Depression Rating Scale - Revised
Time Frame
measured at 8 month follow-up (week 32)
Title
Health Utilities Index
Description
This measure will aid in cost-effectiveness analyses.
Time Frame
measured at post-treatment (week 16)
Title
Health Utilities Index
Description
This measure will aid in cost-effectiveness analyses.
Time Frame
measured at 8 month follow-up (week 32)

10. Eligibility

Sex
All
Minimum Age & Unit of Time
8 Years
Maximum Age & Unit of Time
16 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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)
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
V. Robin Weersing, Ph.D.
Organizational Affiliation
San Diego State University
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
David A Brent, M.D.
Organizational Affiliation
Western Psychiatric Institute and Clinics
Official's Role
Principal Investigator
Facility Information:
Facility Name
San Diego State University
City
San Diego
State/Province
California
ZIP/Postal Code
92120
Country
United States
Facility Name
Western Psychiatric Institute and Clinics
City
Pittsburgh
State/Province
Pennsylvania
ZIP/Postal Code
15213
Country
United States

12. IPD Sharing Statement

Citations:
Citation
Weersing VR, Gonzalez A, Campo JV, Lucas AN. Brief behavioral therapy for pediatric anxiety and depression: Piloting an integrated treatment approach. Cognitive and Behavioral Practice 15: 126-139, 2008.
Results Reference
background
PubMed Identifier
36030033
Citation
Schwartz KTG, Kado-Walton M, Dickerson JF, Rozenman M, Brent DA, Porta G, Lynch FL, Gonzalez A, Weersing VR. Brief Behavioral Therapy for Anxiety and Depression in Pediatric Primary Care: Breadth of Intervention Impact. J Am Acad Child Adolesc Psychiatry. 2023 Feb;62(2):230-243. doi: 10.1016/j.jaac.2022.08.007. Epub 2022 Aug 24.
Results Reference
derived
PubMed Identifier
31278996
Citation
Brent DA, Porta G, Rozenman MS, Gonzalez A, Schwartz KTG, Lynch FL, Dickerson JF, Iyengar S, Weersing VR. Brief Behavioral Therapy for Pediatric Anxiety and Depression in Primary Care: A Follow-up. J Am Acad Child Adolesc Psychiatry. 2020 Jul;59(7):856-867. doi: 10.1016/j.jaac.2019.06.009. Epub 2019 Jul 3.
Results Reference
derived
PubMed Identifier
28423145
Citation
Weersing VR, Brent DA, Rozenman MS, Gonzalez A, Jeffreys M, Dickerson JF, Lynch FL, Porta G, Iyengar S. Brief Behavioral Therapy for Pediatric Anxiety and Depression in Primary Care: A Randomized Clinical Trial. JAMA Psychiatry. 2017 Jun 1;74(6):571-578. doi: 10.1001/jamapsychiatry.2017.0429.
Results Reference
derived
Links:
URL
http://www.sci.sdsu.edu/chaamp/
Description
Click here for more information about this study: Brief CBT for Pediatric Anxiety and Depression in Primary Care
URL
http://www.Pedspittnet.pitt.edu
Description
Click here for more information about this study: Brief CBT for Pediatric Anxiety and Depression in Primary Care

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

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