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

This study has been completed.
Sponsor:
Collaborators:
University of Pittsburgh
Kaiser Permanente
National Institute of Mental Health (NIMH)
Information provided by (Responsible Party):
V. Robin Weersing, San Diego State University
ClinicalTrials.gov Identifier:
NCT01147614
First received: June 17, 2010
Last updated: April 12, 2016
Last verified: April 2016
  Purpose
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.

Condition Intervention
Anxiety
Depression
Behavioral: Brief Cognitive Behavioral Therapy (BCBT)
Behavioral: Specialty mental health care referral (SMHC)

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Brief CBT for Pediatric Anxiety and Depression in Primary Care

Resource links provided by NLM:


Further study details as provided by San Diego State University:

Primary Outcome Measures:
  • Clinical Global Impression [ Time Frame: measured at baseline (week 0) ] [ Designated as safety issue: No ]
  • Clinical Global Impression [ Time Frame: measured at post-treatment (week 16) ] [ Designated as safety issue: No ]
  • Clinical Global Impression [ Time Frame: measured at 8 month follow-up (week 32) ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Pediatric Anxiety Rating Scale [ Time Frame: measured at baseline (week 0) ] [ Designated as safety issue: No ]
  • Children's Depression Rating Scale - Revised [ Time Frame: measured at baseline (week 0) ] [ Designated as safety issue: No ]
  • Health Utilities Index [ Time Frame: measured at baseline (week 0) ] [ Designated as safety issue: No ]
    This measure will aid in cost-effectiveness analyses.

  • Pediatric Anxiety Rating Scale [ Time Frame: measured at post-treatment (week 16) ] [ Designated as safety issue: No ]
  • Pediatric Anxiety Rating Scale [ Time Frame: measured at 8 month follow-up (week 32) ] [ Designated as safety issue: No ]
  • Children's Depression Rating Scale - Revised [ Time Frame: measured at post-treatment (week 16) ] [ Designated as safety issue: No ]
  • Children's Depression Rating Scale - Revised [ Time Frame: measured at 8 month follow-up (week 32) ] [ Designated as safety issue: No ]
  • Health Utilities Index [ Time Frame: measured at post-treatment (week 16) ] [ Designated as safety issue: No ]
    This measure will aid in cost-effectiveness analyses.

  • Health Utilities Index [ Time Frame: measured at 8 month follow-up (week 32) ] [ Designated as safety issue: No ]
    This measure will aid in cost-effectiveness analyses.


Enrollment: 185
Study Start Date: September 2010
Study Completion Date: April 2016
Primary Completion Date: April 2016 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: specialty mental health care referral Behavioral: Specialty mental health care referral (SMHC)
SMHC: specialty mental health care referrals provided
Other Name: SMHC
Experimental: Brief Cognitive Behavioral Therapy 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
Other Name: BCBT

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.
  Eligibility

Ages Eligible for Study:   8 Years to 16 Years   (Child)
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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)
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01147614

Locations
United States, California
San Diego State University
San Diego, California, United States, 92120
United States, Pennsylvania
Western Psychiatric Institute and Clinics
Pittsburgh, Pennsylvania, United States, 15213
Sponsors and Collaborators
San Diego State University
University of Pittsburgh
Kaiser Permanente
National Institute of Mental Health (NIMH)
Investigators
Principal Investigator: V. Robin Weersing, Ph.D. San Diego State University
Principal Investigator: David A Brent, M.D. Western Psychiatric Institute and Clinics
  More Information

Additional Information:
Publications:
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.

Responsible Party: V. Robin Weersing, Associate Professor, San Diego State University
ClinicalTrials.gov Identifier: NCT01147614     History of Changes
Other Study ID Numbers: 7887933  5R01MH084935 
Study First Received: June 17, 2010
Last Updated: April 12, 2016
Health Authority: United States: Institutional Review Board

Keywords provided by San Diego State University:
Child
adolescent
anxiety
depression
internalizing
cognitive behavioral therapy
pediatric primary care

Additional relevant MeSH terms:
Depression
Depressive Disorder
Anxiety Disorders
Behavioral Symptoms
Mood Disorders
Mental Disorders

ClinicalTrials.gov processed this record on August 30, 2016