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

Sponsor

San Diego State University (Other)

Overall Status

Completed

CT.gov ID

NCT01147614

Collaborator

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

185

Enrollment

Locations

Arms

Duration (Months)

92.5

Patients Per Site

1.4

Patients Per Site Per Month

Study Details

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.

Condition or Disease	Intervention/Treatment	Phase
Anxiety Depression	Behavioral: Brief Cognitive Behavioral Therapy (BCBT) Behavioral: Specialty mental health care referral (SMHC)	N/A

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

Study Type:

Interventional

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 :

Sep 1, 2010

Actual Primary Completion Date :

Apr 1, 2016

Actual Study Completion Date :

Apr 1, 2016

Arms and Interventions

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

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

Outcome Measures

Primary Outcome Measures

Clinical Global Impression [measured at baseline (week 0)]
Clinical Global Impression [measured at post-treatment (week 16)]
Clinical Global Impression [measured at 8 month follow-up (week 32)]

Secondary Outcome Measures

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

Eligibility Criteria

Criteria

Ages Eligible for Study:

8 Years to 16 Years

Sexes Eligible for Study:

All

Accepts 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)

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	San Diego State University	San Diego	California	United States	92120
2	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