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

Study Description

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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

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.

Condition or disease	Intervention/treatment	Phase
Anxiety; Depression	Behavioral: Brief Cognitive Behavioral Therapy (BCBT); Behavioral: Specialty mental health care referral (SMHC)	Not Applicable

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 Design

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Study Type :	Interventional (Clinical Trial)
Actual Enrollment :	185 participants
Allocation:	Randomized
Intervention Model:	Parallel Assignment
Masking:	Single (Outcomes Assessor)
Primary Purpose:	Treatment
Official Title:	Brief CBT for Pediatric Anxiety and Depression in Primary Care
Study Start Date :	September 2010
Actual Primary Completion Date :	April 2016
Actual Study Completion Date :	April 2016

Arms and Interventions

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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

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 Name: 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 Name: BCBT

Outcome Measures

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Primary Outcome Measures :

1. Clinical Global Impression [ Time Frame: measured at baseline (week 0) ]
2. Clinical Global Impression [ Time Frame: measured at post-treatment (week 16) ]
3. Clinical Global Impression [ Time Frame: measured at 8 month follow-up (week 32) ]

Secondary Outcome Measures :

1. Pediatric Anxiety Rating Scale [ Time Frame: measured at baseline (week 0) ]
2. Children's Depression Rating Scale - Revised [ Time Frame: measured at baseline (week 0) ]
3. Health Utilities Index [ Time Frame: measured at baseline (week 0) ]
   This measure will aid in cost-effectiveness analyses.
4. Pediatric Anxiety Rating Scale [ Time Frame: measured at post-treatment (week 16) ]
5. Pediatric Anxiety Rating Scale [ Time Frame: measured at 8 month follow-up (week 32) ]
6. Children's Depression Rating Scale - Revised [ Time Frame: measured at post-treatment (week 16) ]
7. Children's Depression Rating Scale - Revised [ Time Frame: measured at 8 month follow-up (week 32) ]
8. Health Utilities Index [ Time Frame: measured at post-treatment (week 16) ]
   This measure will aid in cost-effectiveness analyses.
9. Health Utilities Index [ Time Frame: measured at 8 month follow-up (week 32) ]
   This measure will aid in cost-effectiveness analyses.

Eligibility Criteria

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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Ages Eligible for Study:	8 Years to 16 Years (Child)
Sexes Eligible for Study:	All
Accepts Healthy Volunteers:	No

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)

Contacts and Locations

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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Locations

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

Sponsors and Collaborators

San Diego State University

University of Pittsburgh

Kaiser Permanente

National Institute of Mental Health (NIMH)

Investigators

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

More Information

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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Additional Information:

Click here for more information about this study: Brief CBT for Pediatric Anxiety and Depression in Primary Care 

Click here for more information about this study: Brief CBT for Pediatric Anxiety and Depression in Primary Care 

Publications:

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.

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

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.

Responsible Party:	V. Robin Weersing, Associate Professor, San Diego State University
ClinicalTrials.gov Identifier:	NCT01147614 History of Changes
Other Study ID Numbers:	7887933; 5R01MH084935 ( U.S. NIH Grant/Contract )
First Posted:	June 22, 2010
Last Update Posted:	April 14, 2016
Last Verified:	April 2016

Keywords provided by V. Robin Weersing, San Diego State University:

Child; adolescent; anxiety; depression	internalizing; cognitive behavioral therapy; pediatric primary care

Additional relevant MeSH terms:

Depression; Depressive Disorder; Anxiety Disorders	Behavioral Symptoms; Mood Disorders; Mental Disorders