Neurofunctional Effects of Mindfulness Based Cognitive Therapy for Youth With Symptoms of Anxiety and a Familial Risk for Developing Bipolar Disorder
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 35
- 试验地点
- 2
- 主要终点
- The Pediatric Anxiety Rating Scale
研究概览
简要总结
Children who have parents with bipolar disorder are at risk for developing anxiety disorders.
详细描述
Children who have parents with bipolar disorder are at risk for developing anxiety disorders. Typical treatments for anxiety in children are SSRI antidepressants. However, these medications may accelerate the onset of mania or hypomania in children with a family history of bipolar disorder or cause suicidal thinking in children. Studies trying alternative treatments to anxiety and possible bipolar disorder in children are needed, to establish other methods for treating childhood mental health. These studies can also help with early intervention and possible future prevention strategies for bipolar disorder. This study involves treating anxious children with Mindfulness Based Cognitive Therapy. They will have 12 weeks of mindfulness therapy in a group with other children where they will be led by a trained group leader, how to pay attention to anxiety cues and react differently.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 10 Years 至 17 Years（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •10-17 years old
- •At least one parent with bipolar disorder
- •Meets clinical criteria for a specific anxiety disorder
- •PARS -5 item scale score > 10 at screening and baseline of initial study phase
- •Fluent in English;
- •Provision of written informed consent/assent
- •Agrees to participate in 75% of sessions
排除标准
- •CANNOT Have any of the Following:
- •Documented diagnosis of mental retardation or IQ <70
- •Previous participation in mindfulness-based treatment
- •Substance use disorder within last 3 months
- •Judged clinically to be suicide risk
- •Concurrent treatment with psychotropic medication (certain exceptions apply, ask for details)
- •Psychotherapy initiated within 2 months prior to screening or plan to initiate psychotherapy during study participation
- •Any lifetime diagnosis of bipolar disorder, cyclothymia, schizophrenia, or other psychotic disorder
- •Any symptom that requires admission to an inpatient psychiatric unit
- •Anxiety symptoms resulting from acute medical illness or acute intoxication or withdrawal from drugs or alcohol
结局指标
主要结局
The Pediatric Anxiety Rating Scale
时间窗: 12 weeks
Change from baseline to endpoint in the Pediatric Anxiety Rating Scale (PARS) score. The PARS is a rating scale (a form that a clinician fills out) to determine the severity of anxiety in children.
次要结局
- Mood(12 weeks)
- Behavioral(12 weeks)
- Change in other Anxiety(12 weeks)
- Quality of Life(12 weeks)
研究者
Melissa Delbello
MD
University of Cincinnati