Prevention of Depression in At-Risk Adolescents
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 316
- 试验地点
- 4
- 主要终点
- Onset of a probable or definite depressive episodes (i.e., Depression Symptom Rating greater or equal to 4)
研究概览
简要总结
This study examines the impact of a group cognitive behavioral program aimed at preventing depressive disorders and symptoms in adolescents at risk for developing depression.
详细描述
Depression is a prevalent, chronic, and impairing condition that is often undetected and becomes more difficult to treat as chronicity increases. There is an increasing need to conduct large-scale depression prevention studies in adolescents. This study evaluates a cognitive-behavioral prevention (CBP) program to determine its effectiveness in preventing depressive disorders in at-risk adolescents. The study also will ascertain the costs this intervention to inform attempts at future dissemination of the program in "real world" settings.
Participants in this study are randomly assigned to receive either CBP for eight weekly and 6 monthly continuation sessions or usual care. Depressive symptoms and disorders, levels of functioning, and medical and mental health care utilization are assessed at baseline and again at 2, 8, 20, and 32 months after intake.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- Single (Outcomes Assessor)
盲法说明
Outcome assessor were unaware of condition assignment
入排标准
- 年龄范围
- 13 Years 至 17 Years（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •A parent has had a depressive disorder during child's life
- •Adolescent has had a past depressive episode or has current subsyndromal depressive symptoms measured on the Center for Epidemiological Studies Depression Scale (CES-D)
排除标准
- •adolescent or parent ever diagnosed with bipolar I or schizophrenia;
- •adolescent has a current DSM-IV mood disorder diagnosis
研究组 & 干预措施
1= Cognitive behavioral prevention of depression program
Participants receive a group cognitive-behavioral prevention program, which involved 8 weekly sessions and 6 monthly sessions of CBT skills such as cognitive restructuring, problem-solving, assertivenss, and behavioral activation. Participants in this arm also were able to seek the same kinds of nonstudy treatments as described in the usual care arm.
干预措施: Cognitive-behavioral prevention program (Behavioral)
2 = Usual care
Participants receive usual care, which involves any type of treatment (e.g., psychotherapy, counseling, pharmacotherapy).
干预措施: Usual care (Other)
结局指标
主要结局
Onset of a probable or definite depressive episodes (i.e., Depression Symptom Rating greater or equal to 4)
时间窗: Time to a score of 4 or higher between baseline and 9 months using survival analysis
a score of 4 or greater is considered an onset
次要结局
- Number of depression-free days(Measured continuously through Month 33)
研究者
Judith Garber
Professor
Vanderbilt University