Brief Cognitive Behavioral Therapy (CBT) for Pediatric Anxiety and Depression in Primary Care (BCBT-PC)
This study is currently recruiting participants.
Verified June 2012 by San Diego State University
Sponsor:
San Diego State University
Collaborators:
University of Pittsburgh
Kaiser Permanente
Information provided by:
San Diego State University
ClinicalTrials.gov Identifier:
NCT01147614
First received: June 17, 2010
Last updated: July 5, 2012
Last verified: June 2012
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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 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.
| Estimated Enrollment: | 210 |
| Study Start Date: | September 2010 |
| Estimated Study Completion Date: | August 2015 |
| Estimated Primary Completion Date: | August 2015 (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 |
| 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
Please refer to this study by its ClinicalTrials.gov identifier: NCT01147614
Contacts
| Contact: Megan C Jeffreys, B.A. | (619) 594-8898 | mjeffrey@ucsd.edu |
| Contact: Gina Acquavita, M.S.Ed | (412) 246-5602 | acquavitagm@upmc.edu |
Locations
| United States, California | |
| San Diego State University | Recruiting |
| San Diego, California, United States, 92120 | |
| Contact: Megan C Jeffreys, B.A. 619-594-8898 mjeffrey@ucsd.edu | |
| Principal Investigator: V. Robin Weersing, Ph.D. | |
| United States, Pennsylvania | |
| Western Psychiatric Institute and Clinics | Recruiting |
| Pittsburgh, Pennsylvania, United States, 15213 | |
| Contact: Gina Acquavita, M.S.Ed acquavitagm@upmc.edu | |
| Principal Investigator: David A Brent, M.D. | |
Sponsors and Collaborators
San Diego State University
University of Pittsburgh
Kaiser Permanente
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, Ph.D. / Assistant Professor, San Diego State University |
| ClinicalTrials.gov Identifier: | NCT01147614 History of Changes |
| Other Study ID Numbers: | 7887933, R01MH084935 |
| Study First Received: | June 17, 2010 |
| Last Updated: | July 5, 2012 |
| 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:
|
Anxiety Disorders Depression Depressive Disorder |
Mental Disorders Behavioral Symptoms Mood Disorders |
ClinicalTrials.gov processed this record on May 23, 2013