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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

185 participants

Study Classification

INTERVENTIONAL

Study Start Date

2010-09-30

Study Completion Date

2016-04-30

Brief Summary

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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.

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Detailed Description

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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.

Conditions

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Anxiety Depression

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Outcome Assessors

Study Groups

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specialty mental health care referral

Group Type ACTIVE_COMPARATOR

Specialty mental health care referral (SMHC)

Intervention Type BEHAVIORAL

SMHC: specialty mental health care referrals provided

Brief Cognitive Behavioral Therapy

Group Type EXPERIMENTAL

Brief Cognitive Behavioral Therapy (BCBT)

Intervention Type BEHAVIORAL

BCBT: 8-12 sessions over 16 weeks of cognitive-behavioral therapy administered by Master's-level clinicians in primary care setting

Interventions

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Brief Cognitive Behavioral Therapy (BCBT)

BCBT: 8-12 sessions over 16 weeks of cognitive-behavioral therapy administered by Master's-level clinicians in primary care setting

Intervention Type BEHAVIORAL

Specialty mental health care referral (SMHC)

SMHC: specialty mental health care referrals provided

Intervention Type BEHAVIORAL

Other Intervention Names

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BCBT SMHC

Eligibility Criteria

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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)

Minimum Eligible Age

8 Years

Maximum Eligible Age

16 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No