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

Not Applicable

Completed

• Conditions: Anxiety; Depression
• Interventions: Behavioral: Specialty mental health care referral (SMHC); Behavioral: Brief Cognitive Behavioral Therapy (BCBT)

• Registration Number: NCT01147614
• Lead Sponsor: San Diego State University

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.

Study Timeline

• Study First Submitted: 2010-06-17
• Study First Submitted QC: 2010-06-21
• Study First Posted: 2010-06-22
• Study Start: 2010-09
• Status Verified: 2016-04
• Primary Completion: 2016-04
• Study Completion: 2016-04
• Last Update Submitted: 2016-04-12
• Last Update Posted: 2016-04-14

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 185

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)

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
specialty mental health care referral	Specialty mental health care referral (SMHC)	-
Brief Cognitive Behavioral Therapy	Brief Cognitive Behavioral Therapy (BCBT)	-

Primary Outcome Measures

Name	Time	Method
Clinical Global Impression	measured at 8 month follow-up (week 32)

Secondary Outcome Measures

Name	Time	Method
Health Utilities Index	measured at 8 month follow-up (week 32)	This measure will aid in cost-effectiveness analyses.
Pediatric Anxiety Rating Scale	measured at 8 month follow-up (week 32)
Children's Depression Rating Scale - Revised	measured at 8 month follow-up (week 32)

Trial Locations

Locations (2)

San Diego State University; 🇺🇸 San Diego, California, United States

Western Psychiatric Institute and Clinics; 🇺🇸 Pittsburgh, Pennsylvania, United States