Child/Adolescent Anxiety Multimodal Treatment Study
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 488
- 试验地点
- 6
- 主要终点
- Clinical Global Impression - Improvement Scale
研究概览
简要总结
This randomized, controlled trial compared the efficacy of the medication sertraline (Zoloft®), cognitive-behavioral therapy, the combination of these treatments, and placebo for youth with anxiety disorders.
详细描述
Anxiety disorders are among the most common conditions affecting children and adolescents. These disorders impair school, social, and family functioning. When left untreated, they also put children at risk for major depression and substance abuse in late adolescence and adulthood. Previous studies demonstrated the efficacy of cognitive behavioral therapy and selective serotonin-reuptake inhibitors for the treatment of child anxiety disorders. This study is testing the relative and combined efficacy of cognitive behavioral therapy and selective serotonin reuptake inhibitors as compared to each other and pill placebo.
During Phase I of this two-phase study, 488 participants were randomly assigned to receive sertraline (Zoloft), cognitive behavioral therapy, a combination of these treatments, or a placebo for 12 weeks. Phase II involved a 6-month maintenance period for participants.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Factorial
- 主要目的
- Treatment
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 7 Years 至 17 Years（Child）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Diagnostic and Statistical Manual of Mental Disorders (DSM-IV) criteria for separation anxiety disorder, social phobia, or generalized anxiety disorder
排除标准
- •Major neurological disorder or medical illness that would interfere with participation in the study
研究组 & 干预措施
Sertraline
Participants received sertraline for 12 weeks.
干预措施: Sertraline (SRT) (Drug)
CBT
Participants received cognitive behavioral therapy for 12 weeks
干预措施: Cognitive Behavioral Therapy (CBT) (Behavioral)
SRT + CBT
Participants received both sertraline and CBT for 12 weeks.
干预措施: Sertraline (SRT) (Drug)
SRT + CBT
Participants received both sertraline and CBT for 12 weeks.
干预措施: Cognitive Behavioral Therapy (CBT) (Behavioral)
Placebo
Participants received a placebo pill for 12 weeks.
干预措施: Placebo (Drug)
结局指标
主要结局
Clinical Global Impression - Improvement Scale
时间窗: Measured at Week 12
The Clinical Global Impression - Improvement scale (CGI-I) is a 7 point scale that requires the clinician to assess how much the patient's illness has improved or worsened relative to a baseline state at the beginning of the intervention and rated as: 1-Very much improved; 2-Much improved; 3-Minimally improved; 4-No change; 5-Minimally worse; 6-Much worse; 7-Very much worse. Response rates are reported as a percentage of participants who score 1-Very much improved; 2-Much improved on the The Clinical Global Impression - Improvement scale.
次要结局
未报告次要终点