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

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01147614
First Posted: June 22, 2010
Last Update Posted: April 14, 2016
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Collaborators:
University of Pittsburgh
Kaiser Permanente
National Institute of Mental Health (NIMH)
Information provided by (Responsible Party):
V. Robin Weersing, San Diego State University
June 17, 2010
June 22, 2010
April 14, 2016
September 2010
April 2016   (Final data collection date for primary outcome measure)
  • 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) ]
Same as current
Complete list of historical versions of study NCT01147614 on ClinicalTrials.gov Archive Site
  • 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.
Same as current
Not Provided
Not Provided
 
Brief Cognitive Behavioral Therapy (CBT) for Pediatric Anxiety and Depression in Primary Care
Brief CBT for Pediatric Anxiety and Depression in Primary Care
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.
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.
Interventional
Not Provided
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Treatment
  • Anxiety
  • Depression
  • 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
  • Behavioral: Specialty mental health care referral (SMHC)
    SMHC: specialty mental health care referrals provided
    Other Name: SMHC
  • Active Comparator: specialty mental health care referral
    Intervention: Behavioral: Specialty mental health care referral (SMHC)
  • Experimental: Brief Cognitive Behavioral Therapy
    Intervention: Behavioral: Brief Cognitive Behavioral Therapy (BCBT)
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.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
185
April 2016
April 2016   (Final data collection date for primary outcome measure)

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)
Sexes Eligible for Study: All
8 Years to 16 Years   (Child)
No
Contact information is only displayed when the study is recruiting subjects
United States
 
 
NCT01147614
7887933
5R01MH084935 ( U.S. NIH Grant/Contract )
Yes
Not Provided
Not Provided
V. Robin Weersing, San Diego State University
San Diego State University
  • University of Pittsburgh
  • Kaiser Permanente
  • National Institute of Mental Health (NIMH)
Principal Investigator: V. Robin Weersing, Ph.D. San Diego State University
Principal Investigator: David A Brent, M.D. Western Psychiatric Institute and Clinics
San Diego State University
April 2016

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP