Open Trial of Behavioral Activation Therapy for Depressed or Anxious Adolescents With Cancer
试验速览
- 阶段
- 不适用
- 状态
- 撤回
- 试验地点
- 1
- 主要终点
- Change in Multidimensional Anxiety Scale for Children (MASC 2)
研究概览
简要总结
At present, there are no established treatments for depression or anxiety in adolescents with cancer, creating an important clinical and research gap. Fortunately, there is now substantial evidence documenting the efficacy of psychotherapy in the treatment of depressed and anxious adolescents in the general population.
详细描述
Despite the high prevalence of depression and anxiety in cancer patients, little is known about the efficacy of psychotherapy in depressed and anxious adolescents with cancer.
Behavioral activation therapy (BAT) is a brief, manualized therapy that has shown efficacy in the treatment of major depressive disorder (MDD) and generalized anxiety disorder (GAD) in several controlled trials patients, including adult cancer patients. The goal of this open label clinical trial is to obtain preliminary evidence of the efficacy of BAT(6 sessions) in a group of adolescent cancer patients with MDD, GAD or adjustment disorder with mood or anxiety features.
We will test the efficacy of BAT using the Multidimensional Anxiety Scale for Children at several time points of the treatment.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- Single (Outcomes Assessor)
入排标准
- 年龄范围
- 12 Years 至 21 Years（Child, Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •A primary psychiatric diagnosis of Major Depressive Disorder, Generalized Anxiety Disorder or Adjustment Disorder with Mood or Anxiety features as defined by DSM-IV.
- •Cancer patients.
- •Parent consent and child assent to participate for patients younger than
- •Patient consent for subjects 18-
- •Diagnosis of cancer (stage 1-4), but healthy enough to complete study procedures.
排除标准
- •Lifetime history of psychosis or bipolar disorder.
- •Current suicide risk.
- •History of substance abuse or dependence in the three months prior to the study.
- •Patients who have ever failed BAT in the context of cancer.
- •Receiving other concurrent therapy for same disorder and patients who are receiving effective medication for depression.
- •Mental retardation.
- •CNS tumors.
- •Patients undergoing Stem Cell Transplantation.
结局指标
主要结局
Change in Multidimensional Anxiety Scale for Children (MASC 2)
时间窗: baseline, and every two weeks till week 10
10 to 15 minutes of mood assessment.
次要结局
未报告次要终点