Clinical and Cost Effectiveness of Brief Cognitive-Behavioral Therapy (CBT) for Pediatric Internalizing Disorders

Clinical and Cost Effectiveness of Brief CBT for Pediatric Internalizing Disorders

Status

Completed

Phases

Phase 2

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00669526

Enrollment

Registered

2008-04-30

Start date

2004-10-31

Completion date

2007-04-30

Last updated

2008-04-30

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

Conditions

Anxiety, Depression

Keywords

anxiety, depression, Major Depressive Disorder, child, adolescent, CBT, Cognitive-Behavioral Therapy, primary care

Brief summary

This project assesses the clinical and cost effectiveness of brief cognitive-behavioral therapy (CBT) for depressed (ages 11-17) and anxious (ages 8-17) youths seen for services in pediatric primary care. This study is designed to compare the impact of brief CBT delivered on-site in pediatric primary care to referral to specialty mental health care (SMHC), as well as obtain an estimate of the total costs of the CBT protocols for depression and anxiety and the cost-effectiveness of the protocols compared to referral to and utilization of SMHC services.

Interventions

BEHAVIORALBCBT

Brief Cognitive Behavioral Therapy. This BCBT protocol consists of up to 8 CBT sessions to be conducted over a maximum of 12 weeks.

BEHAVIORALSMHC referral

Referral to local Speciality Mental Health Care. Families were referred to local mental health care providers, and could freely choose any treatment or combination of treatments offered (e.g., anti-depressant medication, individual psychotherapy, family psychotherapy, etc.).

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

SINGLE (Outcomes Assessor)

Eligibility

Sex/Gender

ALL

Age

7 Years to 17 Years

Healthy volunteers

Inclusion criteria

for depression: * Ages 11 to 17 years * Meet diagnostic criteria for Major Depression, Dysthymia, or Minor Depression * Live with a legal guardian Inclusion Criteria for anxiety: * Ages 7 to 17 years * Meet full or probable (missing one, non-core symptom) diagnostic criteria for Separation Anxiety Disorder, Generalized Anxiety Disorder, Social Phobia, or Specific Phobia * Live with a legal guardian

Exclusion criteria

* Require treatment other than brief CBT (namely, youths with bipolar disorder, psychosis, active suicidal ideation with plan, post-traumatic stress disorder, substance dependence, or mental retardation * Experience of recent physical or sexual maltreatment * Serious or unstable physical illness * Current participation in an alternate, active intervention for the target condition of interest

Design outcomes

Primary

Measure	Time frame
Clinician Global Impressions - Improvement (CGI-I)	weeks 12 and 24

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026