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临床试验/NCT00705380
NCT00705380已完成不适用

Cognitive-Behavioral Treatment of Panic in Adolescence

Boston University Charles River Campus1 个研究点 分布在 1 个国家目标入组 25 人开始时间: 1998年7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
25
试验地点
1
主要终点
Anxiety Disorders Interview Schedule-Child and Parent Versions: Clinical Severity Rating, Agoraphobia Ratings, Weekly Panic Attack Frequency Scores, and Monthly Panic Attack Frequency Scores

研究概览

简要总结

This study will evaluate the effectiveness of cognitive behavioral therapy with a panic control treatment component in treating adolescents with panic disorder.

详细描述

More than 3 million people in the United States will experience a panic attack at some point in their lives. A panic attack occurs when a person experiences an intense feeling of sudden fear as well as physical sensations of breathlessness, rapid heart beat, and dizziness. Panic disorder, which is characterized by reoccurring panic attacks, often develops during childhood or adolescence and, if left untreated, can interfere with a child's normal development, relationships, school work, and psychological well-being. Cognitive behavioral therapy (CBT) with a panic control treatment (PCT) component is a type of psychotherapy that teaches new ways to control anxiety or panic attacks. It has been found to be effective in treating adults with panic disorder. However, more research is needed to determine if CBT with PCT, when adapted specifically for adolescents, is also effective in treating adolescents with panic disorder. This study will evaluate the effectiveness of CBT with a PCT component in treating adolescents with panic disorder.

Participation in this study will last up to 18 months. All participants will first undergo baseline assessments that will include a behavioral/psychological assessment while wearing a heart-rate monitoring device; questionnaires relating to experiences of anxiety, fear, and depression; and parent and child clinical interviews. Participants will then be assigned randomly to receive either immediate CBT with PCT or delayed CBT with PCT, which will occur after a 12-week waitlist period. CBT with PCT for all participants will include 11 weekly individual sessions, lasting 60 minutes each. During sessions, participants will learn specifically designed ways for adolescents to reduce or overcome panic attacks. Throughout treatment, participants will keep daily records of their anxiety and will complete self-monitoring forms to monitor panic attacks. During the 12-week waitlist period, the waitlist group participants will complete the same daily records and self-monitoring forms. The waitlist group participants will also meet with a therapist once every other week to discuss the nature of any panic attacks or address any concerns. Once all 12 weeks have passed, they will begin CBT with PCT. All participants will repeat the baseline assessments at Months 3, 6, and 12 after treatment.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Treatment
盲法
Single (Outcomes Assessor)

入排标准

年龄范围
12 Years 至 17 Years(Child)
性别
All
接受健康志愿者
否

入选标准

  • •Meets DSM-IV criteria for principal diagnosis of panic disorder or panic disorder with agoraphobia prior to treatment
  • •If on medication, must undergo a 1-month stabilization period for benzodiazepines or 3-month stabilization period for selective serotonin reuptake inhibitors or tricyclics before study entry

排除标准

  • •Positive diagnosis of schizophrenia, pervasive developmental disorder, organic brain syndrome, or mental retardation
  • •Current suicidal ideation
  • •Refusal of parent to accept random assignment to treatment condition
  • •Refusal of parent or adolescent to accept stabilization of medication

研究组 & 干预措施

1

Experimental

Participants will receive cognitive behavioral therapy with panic control treatment.

干预措施: Cognitive behavioral therapy (CBT) with panic control treatment (PCT) for adolescents (Behavioral)

2

Active Comparator

Participants will receive cognitive behavioral therapy with panic control treatment after a 12-week waitlist period.

干预措施: Cognitive behavioral therapy (CBT) with panic control treatment (PCT) for adolescents (Behavioral)

2

Active Comparator

Participants will receive cognitive behavioral therapy with panic control treatment after a 12-week waitlist period.

干预措施: Waitlist control (Behavioral)

结局指标

主要结局

Anxiety Disorders Interview Schedule-Child and Parent Versions: Clinical Severity Rating, Agoraphobia Ratings, Weekly Panic Attack Frequency Scores, and Monthly Panic Attack Frequency Scores

时间窗: Measured at pretreatment; post-treatment; and Months 3, 6, and 12 of follow-up

Weekly Record of Anxiety and Depression (WRAD)

时间窗: Measured at pretreatment; post-treatment; and Months 3, 6, and 12 of follow-up

The Panic Attack Record (PAR)

时间窗: Measured at pretreatment; post-treatment; and Months 3, 6, and 12 of follow-up

次要结局

  • The Childhood Anxiety Sensitivity Index (CASI)(Measured at pretreatment; post-treatment; and Months 3, 6, and 12 of follow-up)
  • Children's Depression Inventory (CDI)(Measured at pretreatment; post-treatment; and Months 3, 6, and 12 of follow-up)
  • The Fear Survey Schedule for Children - Revised(Measured at pretreatment; post-treatment; and Months 3, 6, and 12 of follow-up)
  • The Revised Children's Manifest Anxiety Scale(Measured at pretreatment; post-treatment; and Months 3, 6, and 12 of follow-up)
  • Behavioral Approach Test (BAT)(Measured at pretreatment; post-treatment; and Months 3, 6, and 12 of follow-up)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (1)

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