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Completed

NCT Number: NCT01147614

Brief Cognitive Behavioral Therapy (CBT) for Pediatric Anxiety and Depression in Primary Care

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.

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Key information

Age range

8 year–16 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

San Diego State University, San Diego, California, United States

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About this study

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.

Who can participate

Healthy volunteers accepted: No

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

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)

Treatment and study plan

Brief Cognitive Behavioral Therapy (BCBT)

Behavioral

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

Other names: BCBT

Specialty mental health care referral (SMHC)

Behavioral

SMHC: specialty mental health care referrals provided

Other names: SMHC

Primary outcomes

  1. Clinical Global Impression

    Time frame: measured at baseline (week 0)

  2. Clinical Global Impression

    Time frame: measured at post-treatment (week 16)

  3. Clinical Global Impression

    Time frame: measured at 8 month follow-up (week 32)

Secondary outcomes

  1. Pediatric Anxiety Rating Scale

    Time frame: measured at baseline (week 0)

  2. Children's Depression Rating Scale - Revised

    Time frame: measured at baseline (week 0)

  3. Health Utilities Index

    Time frame: measured at baseline (week 0)

    This measure will aid in cost-effectiveness analyses.

  4. Pediatric Anxiety Rating Scale

    Time frame: measured at post-treatment (week 16)

  5. Pediatric Anxiety Rating Scale

    Time frame: measured at 8 month follow-up (week 32)

  6. Children's Depression Rating Scale - Revised

    Time frame: measured at post-treatment (week 16)

  7. Children's Depression Rating Scale - Revised

    Time frame: measured at 8 month follow-up (week 32)

  8. Health Utilities Index

    Time frame: measured at post-treatment (week 16)

    This measure will aid in cost-effectiveness analyses.

  9. Health Utilities Index

    Time frame: measured at 8 month follow-up (week 32)

    This measure will aid in cost-effectiveness analyses.

Sponsors and collaborators

Lead sponsor

San Diego State University

Other

Collaborators

  • Kaiser Permanente
  • National Institute of Mental Health (NIMH)
  • University of Pittsburgh

Registry information

Official study title

Brief CBT for Pediatric Anxiety and Depression in Primary Care

Acronym: BCBT-PC

Important dates

Study start
2010
Primary completion
2016
Study completion
2016
First posted
Jun 22, 2010
Registry last updated
Apr 14, 2016

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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