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
|
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Condition or disease | Intervention/treatment | Phase |
---|---|---|
Anxiety Depression | Behavioral: Brief Cognitive Behavioral Therapy (BCBT) Behavioral: Specialty mental health care referral (SMHC) | Not Applicable |
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 |
Actual Primary Completion Date : | April 2016 |
Actual Study Completion Date : | April 2016 |

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
|
- 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) ]
- 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.

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Ages Eligible for Study: | 8 Years to 16 Years (Child) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |
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)

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
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 |
Principal Investigator: | V. Robin Weersing, Ph.D. | San Diego State University | |
Principal Investigator: | David A Brent, M.D. | Western Psychiatric Institute and Clinics |
Additional Information:
Publications:
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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 |