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

Study Overview
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Brief Summary
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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.

Official Title
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Clinical and Cost Effectiveness of Brief CBT for Pediatric Internalizing Disorders

Conditions
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Depression, Anxiety

Intervention / Treatment
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* Behavioral: BCBT
* Behavioral: SMHC referral


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 7 Years
Maximum Age: 17 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: SMHC referral<br>Referral to local Specialty Mental Health Care Services | Behavioral: SMHC referral<br>* 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.).<br>|
| Experimental: BCBT<br>Brief Cognitive Behavioral Therapy | Behavioral: BCBT<br>* Brief Cognitive Behavioral Therapy. This BCBT protocol consists of up to 8 CBT sessions to be conducted over a maximum of 12 weeks.<br>* Other names: Cognitive-Behavioral Therapy;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Clinician Global Impressions - Improvement (CGI-I) |  | weeks 12 and 24 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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anxiety, depression, Major Depressive Disorder, child, adolescent, CBT, Cognitive-Behavioral Therapy, primary care