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

Depression Clinical Trial

— BCBT-PC  

Official title:

Brief CBT for Pediatric Anxiety and Depression in Primary Care

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01147614
• Other study ID #: 7887933
• Secondary ID: 5R01MH084935
• Status: Completed
• Phase: N/A
• First received: June 17, 2010
• Last updated: April 12, 2016
• Start date: September 2010
• Est. completion date: April 2016

Study information

• Verified date: April 2016
• Source: San Diego State University
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 185
• Est. completion date: April 2016
• Est. primary completion date: April 2016
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 8 Years to 16 Years

Eligibility

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 Design

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

Related Conditions & MeSH terms

• Anxiety
• Anxiety Disorders
• Depression
• Depressive Disorder

Intervention

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
• Specialty mental health care referral (SMHC)
SMHC: specialty mental health care referrals provided

Locations

Country	Name	City	State
United States	Western Psychiatric Institute and Clinics	Pittsburgh	Pennsylvania
United States	San Diego State University	San Diego	California

Sponsors (4)

Lead Sponsor	Collaborator
San Diego State University	Kaiser Permanente, National Institute of Mental Health (NIMH), University of Pittsburgh

Country where clinical trial is conducted

United States, 

References & Publications (1)

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.

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Clinical Global Impression		measured at baseline (week 0)	No
Primary	Clinical Global Impression		measured at post-treatment (week 16)	No
Primary	Clinical Global Impression		measured at 8 month follow-up (week 32)	No
Secondary	Pediatric Anxiety Rating Scale		measured at baseline (week 0)	No
Secondary	Children's Depression Rating Scale - Revised		measured at baseline (week 0)	No
Secondary	Health Utilities Index	This measure will aid in cost-effectiveness analyses.	measured at baseline (week 0)	No
Secondary	Pediatric Anxiety Rating Scale		measured at post-treatment (week 16)	No
Secondary	Pediatric Anxiety Rating Scale		measured at 8 month follow-up (week 32)	No
Secondary	Children's Depression Rating Scale - Revised		measured at post-treatment (week 16)	No
Secondary	Children's Depression Rating Scale - Revised		measured at 8 month follow-up (week 32)	No
Secondary	Health Utilities Index	This measure will aid in cost-effectiveness analyses.	measured at post-treatment (week 16)	No
Secondary	Health Utilities Index	This measure will aid in cost-effectiveness analyses.	measured at 8 month follow-up (week 32)	No

External Links

•   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