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

Overview

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 Title of Study: “Brief CBT for Pediatric Anxiety and Depression in Primary Care”

Study Type

  • Study Type: Interventional
  • Study Design
    • Allocation: Randomized
    • Intervention Model: Parallel Assignment
    • Primary Purpose: Treatment
    • Masking: Single (Outcomes Assessor)
  • Study Primary Completion Date: April 2016

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.

Interventions

  • Behavioral: 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
  • Behavioral: Specialty mental health care referral (SMHC)
    • SMHC: specialty mental health care referrals provided

Arms, Groups and Cohorts

  • Active Comparator: specialty mental health care referral
  • Experimental: Brief Cognitive Behavioral Therapy

Clinical Trial Outcome Measures

Primary Measures

  • Clinical Global Impression
    • Time Frame: measured at baseline (week 0)
  • Clinical Global Impression
    • Time Frame: measured at post-treatment (week 16)
  • Clinical Global Impression
    • Time Frame: measured at 8 month follow-up (week 32)

Secondary Measures

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

Participating in This Clinical Trial

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)

Gender Eligibility: All

Minimum Age: 8 Years

Maximum Age: 16 Years

Are Healthy Volunteers Accepted: No

Investigator Details

  • Lead Sponsor
    • San Diego State University
  • Collaborator
    • University of Pittsburgh
  • Provider of Information About this Clinical Study
    • Principal Investigator: V. Robin Weersing, Associate Professor – San Diego State University
  • Overall Official(s)
    • V. Robin Weersing, Ph.D., Principal Investigator, San Diego State University
    • David A Brent, M.D., Principal Investigator, Western Psychiatric Institute and Clinics

References

Weersing VR, Gonzalez A, Campo JV, Lucas AN. Brief behavioral therapy for pediatric anxiety and depression: Piloting an integrated treatment approach. Cognitive and Behavioral Practice 15: 126-139, 2008.

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