Clinical trial NCT01147614: Brief Cognitive Behavioral Therapy (CBT) for Pediatric Anxiety and Depression in Primary Care
Official title: Brief CBT for Pediatric Anxiety and Depression in Primary Care
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Anxiety
Depression
Keywords: Child
adolescent
anxiety
depression
internalizing
cognitive behavioral therapy
pediatric primary care
Lead sponsor: San Diego State University
Sponsor class: OTHER
Collaborators: name: University of Pittsburgh
name: Kaiser Permanente
name: National Institute of Mental Health (NIMH)
First posted: 2010-06-22
Enrollment: 185
Sex: ALL
Minimum age (years): 8
Maximum age (years): 16
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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 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)

Primary outcomes:
measure: Clinical Global Impression
timeFrame: measured at baseline (week 0)
measure: Clinical Global Impression
timeFrame: measured at post-treatment (week 16)
measure: Clinical Global Impression
timeFrame: measured at 8 month follow-up (week 32)
Secondary outcomes:
measure: Pediatric Anxiety Rating Scale
timeFrame: measured at baseline (week 0)
measure: Children's Depression Rating Scale - Revised
timeFrame: measured at baseline (week 0)
measure: Health Utilities Index
timeFrame: measured at baseline (week 0)
measure: Pediatric Anxiety Rating Scale
timeFrame: measured at post-treatment (week 16)
measure: Pediatric Anxiety Rating Scale
timeFrame: measured at 8 month follow-up (week 32)
measure: Children's Depression Rating Scale - Revised
timeFrame: measured at post-treatment (week 16)
measure: Children's Depression Rating Scale - Revised
timeFrame: measured at 8 month follow-up (week 32)
measure: Health Utilities Index
timeFrame: measured at post-treatment (week 16)
measure: Health Utilities Index
timeFrame: measured at 8 month follow-up (week 32)
Other outcomes:
Locations:
city: San Diego
country: United States
facility: San Diego State University
state: California
city: Pittsburgh
country: United States
facility: Western Psychiatric Institute and Clinics
state: Pennsylvania
Study officials:
affiliation: San Diego State University
name: V. Robin Weersing, Ph.D.
role: PRINCIPAL_INVESTIGATOR
affiliation: Western Psychiatric Institute and Clinics
name: David A Brent, M.D.
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.
citation: Schwartz KTG, Kado-Walton M, Dickerson JF, Rozenman M, Brent DA, Porta G, Lynch FL, Gonzalez A, Weersing VR. Brief Behavioral Therapy for Anxiety and Depression in Pediatric Primary Care: Breadth of Intervention Impact. J Am Acad Child Adolesc Psychiatry. 2023 Feb;62(2):230-243. doi: 10.1016/j.jaac.2022.08.007. Epub 2022 Aug 24.
citation: Brent DA, Porta G, Rozenman MS, Gonzalez A, Schwartz KTG, Lynch FL, Dickerson JF, Iyengar S, Weersing VR. Brief Behavioral Therapy for Pediatric Anxiety and Depression in Primary Care: A Follow-up. J Am Acad Child Adolesc Psychiatry. 2020 Jul;59(7):856-867. doi: 10.1016/j.jaac.2019.06.009. Epub 2019 Jul 3.
citation: Weersing VR, Brent DA, Rozenman MS, Gonzalez A, Jeffreys M, Dickerson JF, Lynch FL, Porta G, Iyengar S. Brief Behavioral Therapy for Pediatric Anxiety and Depression in Primary Care: A Randomized Clinical Trial. JAMA Psychiatry. 2017 Jun 1;74(6):571-578. doi: 10.1001/jamapsychiatry.2017.0429.