Trial record 15 of 158 for:    "mental health" AND (teen OR adolescents) | Open Studies

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:
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
  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 April 16, 2014