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Completed

NCT Number: NCT00669526

Clinical and Cost Effectiveness of Brief Cognitive-Behavioral Therapy (CBT) for Pediatric Internalizing Disorders

This project assesses the clinical and cost effectiveness of brief cognitive-behavioral therapy (CBT) for depressed (ages 11-17) and anxious (ages 8-17) youths seen for services in pediatric primary care. This study is designed to compare the impact of brief CBT delivered on-site in pediatric primary care to referral to specialty mental health care (SMHC), as well as obtain an estimate of the total costs of the CBT protocols for depression and anxiety and the cost-effectiveness of the protocols compared to referral to and utilization of SMHC services.

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Key information

Conditions

Depression Anxiety Anxiety Disorders Behavior Behavioral Symptoms Depressive Disorder Depressive Disorder, Major Mental Disorders Mood Disorders

Age range

7 year–17 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

University of Pittsburgh Medical Center

Pittsburgh, Pennsylvania, 15213, United States

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

for depression:

  • Ages 11 to 17 years
  • Meet diagnostic criteria for Major Depression, Dysthymia, or Minor Depression
  • Live with a legal guardian

Inclusion criteria

for anxiety:

  • Ages 7 to 17 years
  • Meet full or probable (missing one, non-core symptom) diagnostic criteria for Separation Anxiety Disorder, Generalized Anxiety Disorder, Social Phobia, or Specific Phobia
  • Live with a legal guardian

Exclusion criteria

  • Require treatment other than brief CBT (namely, youths with bipolar disorder, psychosis, active suicidal ideation with plan, post-traumatic stress disorder, substance dependence, or mental retardation
  • Experience of recent physical or sexual maltreatment
  • Serious or unstable physical illness
  • Current participation in an alternate, active intervention for the target condition of interest

Treatment and study plan

BCBT

Behavioral

Brief Cognitive Behavioral Therapy. This BCBT protocol consists of up to 8 CBT sessions to be conducted over a maximum of 12 weeks.

Other names: CBT, Cognitive-Behavioral Therapy

SMHC referral

Behavioral

Referral to local Speciality Mental Health Care. Families were referred to local mental health care providers, and could freely choose any treatment or combination of treatments offered (e.g., anti-depressant medication, individual psychotherapy, family psychotherapy, etc.).

Primary outcomes

  1. Clinician Global Impressions - Improvement (CGI-I)

    Time frame: weeks 12 and 24

Sponsors and collaborators

Lead sponsor

Robert Wood Johnson Foundation

Other

Collaborators

  • National Institute of Mental Health (NIMH)
  • William T. Grant Foundation

Registry information

Official study title

Clinical and Cost Effectiveness of Brief CBT for Pediatric Internalizing Disorders

Important dates

Study start
2004
Primary completion
2007
Study completion
2007
First posted
Apr 30, 2008
Registry last updated
Apr 30, 2008

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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