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

San Diego State University

Status: Completed

Conditions: Depression; Anxiety

Treatments: Behavioral: Brief Cognitive Behavioral Therapy (BCBT); Behavioral: Specialty mental health care referral (SMHC)

Study type: Interventional

Funder types: Other; NIH

Identifiers

NCT01147614

7887933

5R01MH084935 (U.S. NIH Grant/Contract)

Details and patient eligibility

About

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.

Full 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.

Enrollment: 185 patients

Sex: All

Ages: 8 to 16 years old

Volunteers: No Healthy Volunteers

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)

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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185 participants in 2 patient groups

specialty mental health care referral

Active Comparator group

Treatment:

Behavioral: Specialty mental health care referral (SMHC)

Brief Cognitive Behavioral Therapy

Experimental group

Treatment:

Behavioral: Brief Cognitive Behavioral Therapy (BCBT)