NCT01147614

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
185

participants targeted

Target at P75+ for not_applicable anxiety

Timeline
Completed

Started Sep 2010

Longer than P75 for not_applicable anxiety

Geographic Reach
1 country

2 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

June 17, 2010

Completed
5 days until next milestone

First Posted

Study publicly available on registry

June 22, 2010

Completed
2 months until next milestone

Study Start

First participant enrolled

September 1, 2010

Completed
5.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 1, 2016

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

April 1, 2016

Completed
Last Updated

April 14, 2016

Status Verified

April 1, 2016

Enrollment Period

5.6 years

First QC Date

June 17, 2010

Last Update Submit

April 12, 2016

Conditions

Keywords

Childadolescentanxietydepressioninternalizingcognitive behavioral therapypediatric primary care

Outcome Measures

Primary Outcomes (3)

  • Clinical Global Impression

    measured at baseline (week 0)

  • Clinical Global Impression

    measured at post-treatment (week 16)

  • Clinical Global Impression

    measured at 8 month follow-up (week 32)

Secondary Outcomes (9)

  • Pediatric Anxiety Rating Scale

    measured at baseline (week 0)

  • Children's Depression Rating Scale - Revised

    measured at baseline (week 0)

  • Health Utilities Index

    measured at baseline (week 0)

  • Pediatric Anxiety Rating Scale

    measured at post-treatment (week 16)

  • Pediatric Anxiety Rating Scale

    measured at 8 month follow-up (week 32)

  • +4 more secondary outcomes

Study Arms (2)

specialty mental health care referral

ACTIVE COMPARATOR
Behavioral: Specialty mental health care referral (SMHC)

Brief Cognitive Behavioral Therapy

EXPERIMENTAL
Behavioral: Brief Cognitive Behavioral Therapy (BCBT)

Interventions

BCBT: 8-12 sessions over 16 weeks of cognitive-behavioral therapy administered by Master's-level clinicians in primary care setting

Also known as: BCBT
Brief Cognitive Behavioral Therapy

SMHC: specialty mental health care referrals provided

Also known as: SMHC
specialty mental health care referral

Eligibility Criteria

Age8 Years - 16 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17)

You may qualify if:

  • 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

You may not qualify if:

  • 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)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

San Diego State University

San Diego, California, 92120, United States

Location

Western Psychiatric Institute and Clinics

Pittsburgh, Pennsylvania, 15213, United States

Location

Related Publications (5)

  • 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.

    BACKGROUND
  • Baca SA, Goger P, Glaser D, Rozenman M, Gonzalez A, Dickerson JF, Lynch FL, Porta G, Brent DA, Weersing VR. Reduction in avoidance mediates effects of brief behavioral therapy for pediatric anxiety and depression. Behav Res Ther. 2023 May;164:104290. doi: 10.1016/j.brat.2023.104290. Epub 2023 Mar 8.

  • 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.

  • 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.

  • 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.

Related Links

MeSH Terms

Conditions

Anxiety DisordersDepression

Condition Hierarchy (Ancestors)

Mental DisordersBehavioral SymptomsBehavior

Study Officials

  • V. Robin Weersing, Ph.D.

    San Diego State University

    PRINCIPAL INVESTIGATOR
  • David A Brent, M.D.

    Western Psychiatric Institute and Clinics

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Associate Professor

Study Record Dates

First Submitted

June 17, 2010

First Posted

June 22, 2010

Study Start

September 1, 2010

Primary Completion

April 1, 2016

Study Completion

April 1, 2016

Last Updated

April 14, 2016

Record last verified: 2016-04

Locations