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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:
San Diego State University
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
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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 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 V. Robin Weersing, San Diego State University:
Primary Outcome 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 Outcome 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.
| 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) |
| 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
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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
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 ( US NIH Grant/Contract Award Number ) |
| Study First Received: | June 17, 2010 |
| Last Updated: | April 12, 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 |
ClinicalTrials.gov processed this record on June 22, 2017