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临床试验/NCT01717508
NCT01717508已完成不适用

Examination of the Neural Components Underlying the Treatment of Adolescent Major Depression

Mclean Hospital1 个研究点 分布在 1 个国家目标入组 112 人开始时间: 2012年10月1日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
已完成
入组人数
112
试验地点
1
主要终点
EEG Activity

研究概览

简要总结

The goal of the study is to examine how cognitive behavioral therapy (CBT), a common treatment for adolescent depression, affects brain functioning. Depressed adolescents will complete an initial assessment consisting of an interview, questionnaires, computer tasks, and an EEG recording. EEG (electroencephalography) measures brain activity by recording the electrical activity along the scalp caused by the firing of neurons within the brain. They will then complete 12 sessions of cognitive behavioral therapy, which will be 50 minutes long and held once a week for 12 weeks. Before their third therapy session, participants will complete a computer task while EEG data are recorded. After completing the treatment, the participants will complete a final assessment, which will include questionnaires, computer tasks, and an EEG recording. They will also complete follow-up assessments over the phone 1, 3, and 6 months after completing the treatment.

This study will also include healthy control participants. They will complete an initial assessment consisting of an interview, questionnaires, computer tasks, and an EEG recording. Three weeks later, they will return to complete a behavioral task while EEG data are recorded. Twelve weeks after the initial assessment, they will complete a final assessment, which will include questionnaires, computer tasks, and an EEG recording.

详细描述

The purpose of the study is to examine the impact of individual cognitive behavioral therapy (CBT) for adolescent depression on neural functioning. Specifically, the study will utilize Brent and Poling's (1997) cognitive behavioral therapy (CBT) manual (Cognitive Therapy Treatment Manual for Depressed and Suicidal Youth), and investigators will examine pre- to post- neural activity patterns for children and adolescents who receive individual CBT for depression. Electroencephalography (EEG) techniques will be utilized to assess treatment-related effects on brain activity (i.e., anterior cingulate cortex and dorsolateral prefrontal cortex functioning). Neural activity patterns will also be compared to non-depressed, healthy controls.

研究设计

研究类型
Interventional
分配方式
Non Randomized
干预模型
Parallel
主要目的
Treatment
盲法
None

入排标准

年龄范围
13 Years 至 18 Years(Child, Adult)
性别
Female
接受健康志愿者
是

入选标准

  • •, Major Depressive Disorder Participants:
  • •Ages 13-18 years at time of initial assessment
  • •Current major depressive disorder (MDD) diagnosed according to the K-SADS Axis I semi-structured interview
  • •English as first language or English fluency

排除标准

  • •, Major Depressive Disorder Participants:
  • •Mania/Hypomania
  • •Current anxiety disorders [e.g., Panic Disorder (PD), Generalized Anxiety Disorder (GAD), Obsessive Compulsive Disorder (OCD)]
  • •Eating Disorders
  • •Substance Abuse/Dependency
  • •Conduct Disorder/Antisocial Disorder
  • •Psychosis
  • •Mental Retardation
  • •Organic Brain Syndrome
  • •Current Psychotherapy Treatment
  • •Medical & neurological illness (head injury, loss of consciousness for more than 5 minutes, seizures)
  • •Current use of psychotropic medication for treatment of MDD with the exception of SSRIs (selective serotonin reuptake inhibitors)
  • •Active suicidality
  • •Inclusion Criteria, Healthy Control Participants:
  • •Ages 13-18 years at time of initial assessment
  • •English as first language or English fluency
  • •Exclusion Criteria, Healthy Control Participants (in addition to the exclusion criteria of the MDD group):
  • •Elevated depressive symptoms as assessed in phone screen

研究组 & 干预措施

Cognitive Behavioral Therapy

Other

12 weekly sessions of cognitive behavioral therapy

干预措施: Cognitive Behavioral Therapy (Behavioral)

Healthy Controls

No Intervention

结局指标

主要结局

EEG Activity

时间窗: 12 weeks

EEG and ERP measures collected during resting state and behavioral tasks

次要结局

未报告次要终点

研究者

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

Randy P. Auerbach

Principal Investigator

Mclean Hospital

研究点 (1)

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