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临床试验/NCT01147614
NCT01147614已完成不适用

Brief CBT for Pediatric Anxiety and Depression in Primary Care

San Diego State University4 个研究点 分布在 1 个国家目标入组 185 人开始时间: 2010年9月最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
185
试验地点
4
主要终点
Clinical Global Impression

研究概览

简要总结

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.

详细描述

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.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Treatment
盲法
Single (Outcomes Assessor)

入排标准

年龄范围
8 Years 至 16 Years(Child)
性别
All
接受健康志愿者

入选标准

  • 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

排除标准

  • 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)

结局指标

主要结局

Clinical Global Impression

时间窗: measured at 8 month follow-up (week 32)

次要结局

  • Health Utilities Index(measured at 8 month follow-up (week 32))
  • Pediatric Anxiety Rating Scale(measured at 8 month follow-up (week 32))
  • Children's Depression Rating Scale - Revised(measured at 8 month follow-up (week 32))

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

V. Robin Weersing

Associate Professor

San Diego State University

研究点 (4)

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