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

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ClinicalTrials.gov Identifier: NCT01147614
Recruitment Status : Completed
First Posted : June 22, 2010
Last Update Posted : April 14, 2016
Sponsor:
Collaborators:
Information provided by (Responsible Party):

Study Description
Brief Summary:
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 or disease Intervention/treatment
Anxiety Depression Behavioral: Brief Cognitive Behavioral Therapy (BCBT) Behavioral: Specialty mental health care referral (SMHC)

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.

Study Design

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 185 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Brief CBT for Pediatric Anxiety and Depression in Primary Care
Study Start Date : September 2010
Primary Completion Date : April 2016
Study Completion Date : April 2016

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Arms and Interventions

Arm Intervention/treatment
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


Outcome Measures

Primary Outcome Measures :
  1. Clinical Global Impression [ Time Frame: measured at baseline (week 0) ]
  2. Clinical Global Impression [ Time Frame: measured at post-treatment (week 16) ]
  3. Clinical Global Impression [ Time Frame: measured at 8 month follow-up (week 32) ]

Secondary Outcome Measures :
  1. Pediatric Anxiety Rating Scale [ Time Frame: measured at baseline (week 0) ]
  2. Children's Depression Rating Scale - Revised [ Time Frame: measured at baseline (week 0) ]
  3. Health Utilities Index [ Time Frame: measured at baseline (week 0) ]
    This measure will aid in cost-effectiveness analyses.

  4. Pediatric Anxiety Rating Scale [ Time Frame: measured at post-treatment (week 16) ]
  5. Pediatric Anxiety Rating Scale [ Time Frame: measured at 8 month follow-up (week 32) ]
  6. Children's Depression Rating Scale - Revised [ Time Frame: measured at post-treatment (week 16) ]
  7. Children's Depression Rating Scale - Revised [ Time Frame: measured at 8 month follow-up (week 32) ]
  8. Health Utilities Index [ Time Frame: measured at post-treatment (week 16) ]
    This measure will aid in cost-effectiveness analyses.

  9. Health Utilities Index [ Time Frame: measured at 8 month follow-up (week 32) ]
    This measure will aid in cost-effectiveness analyses.


Eligibility Criteria

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Ages Eligible for Study:   8 Years to 16 Years   (Child)
Sexes Eligible for Study:   All
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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 ( U.S. NIH Grant/Contract )
First Posted: June 22, 2010    Key Record Dates
Last Update Posted: April 14, 2016
Last Verified: April 2016

Keywords provided by V. Robin Weersing, 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