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

Study Overview
=================
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.

Official Title
-----------------
Brief CBT for Pediatric Anxiety and Depression in Primary Care

Conditions
-----------------
Anxiety, Depression

Intervention / Treatment
-----------------
* Behavioral: Brief Cognitive Behavioral Therapy (BCBT)
* Behavioral: Specialty mental health care referral (SMHC)


Participation Criteria
=================
Eligibility Criteria
-----------------
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)

Ages Eligible for Study
-----------------
Minimum Age: 8 Years
Maximum Age: 16 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: specialty mental health care referral<br> | Behavioral: Specialty mental health care referral (SMHC)<br>* SMHC: specialty mental health care referrals provided<br>* Other names: SMHC;|
| Experimental: Brief Cognitive Behavioral Therapy<br> | Behavioral: Brief Cognitive Behavioral Therapy (BCBT)<br>* BCBT: 8-12 sessions over 16 weeks of cognitive-behavioral therapy administered by Master's-level clinicians in primary care setting<br>* Other names: BCBT;|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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

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

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Child, adolescent, anxiety, depression, internalizing, cognitive behavioral therapy, pediatric primary care