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

Brief CBT for Pediatric Anxiety and Depression in Primary Care

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT01147614
Acronym
BCBT-PC
Enrollment
185
Registered
2010-06-22
Start date
2010-09-30
Completion date
2016-04-30
Last updated
2016-04-14

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Anxiety, Depression

Keywords

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

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.

Interventions

BCBT: 8-12 sessions over 16 weeks of cognitive-behavioral therapy administered by Master's-level clinicians in primary care setting

BEHAVIORALSpecialty mental health care referral (SMHC)

SMHC: specialty mental health care referrals provided

Sponsors

University of Pittsburgh
CollaboratorOTHER
Kaiser Permanente
CollaboratorOTHER
National Institute of Mental Health (NIMH)
CollaboratorNIH
San Diego State University
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Outcomes Assessor)

Eligibility

Sex/Gender
ALL
Age
8 Years to 16 Years
Healthy volunteers
No

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)

Design outcomes

Primary

MeasureTime frame
Clinical Global Impressionmeasured at baseline (week 0)

Secondary

MeasureTime frameDescription
Pediatric Anxiety Rating Scalemeasured at baseline (week 0)
Children's Depression Rating Scale - Revisedmeasured at baseline (week 0)
Health Utilities Indexmeasured at baseline (week 0)This measure will aid in cost-effectiveness analyses.

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Mar 2, 2026