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临床试验/NCT00118911
NCT00118911已完成不适用

Efficacy of CBT for Residual ADHD in Adults

Massachusetts General Hospital2 个研究点 分布在 1 个国家目标入组 86 人开始时间: 2004年9月最近更新:
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
86
试验地点
2
主要终点
Post-treatment ADHD Symptoms

研究概览

简要总结

This study will determine the efficacy of cognitive behavioral therapy in treating adults with attention deficit hyperactivity disorder.

详细描述

Attention deficit hyperactivity disorder (ADHD), previously believed to be a disorder of childhood, affects as many as 5 percent of adults. Adults with ADHD are at high risk for academic and occupational underachievement, relationship difficulties, and reduced quality of life. This study will determine whether cognitive behavioral therapy (CBT) is more effective than ADHD education and relaxation techniques in treating adults with ADHD.

Participants will be randomly assigned to receive 12 to 15 weekly sessions of either CBT or training in which they will learn relaxation techniques and receive detailed information about ADHD. Questionnaires will be used to assess participants' ADHD symptoms at study entry and at study completion.

The study is being conducted at Massachusetts General Hospital in Boston and requires 5 assessment visits and 12 weekly therapy visits. Participants must be able to travel to Boston on a weekly basis in order to participate in the study.

Study hypothesis: CBT is a more efficacious treatment for adult ADHD than education and relaxation techniques.

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
None

入排标准

年龄范围
18 Years 至 65 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Diagnosis of adult ADHD of at least mild clinical severity (CGI score of 3 or greater)
  • Stable on medications for adult ADHD for at least 2 months
  • Between 18 and 65 years old
  • Be able to give informed consent and comply with study procedures

排除标准

  • Moderate to severe major depression, clinically significant panic disorder (CGI for depression or panic greater than 4), bipolar disorder, organic mental disorders, psychotic disorders, or pervasive developmental disorders
  • Active suicidality (HAM-D suicidality item rated 3 or 4)
  • Current substance abuse or dependence
  • IQ less than 90
  • Suicide risk
  • Prior participation in cognitive behavioral therapy for ADHD

研究组 & 干预措施

Cognitive-Behavioral Therapy

Experimental

Participants will receive cognitive-behavioral therapy following our protocol.

干预措施: Cognitive behavioral therapy (CBT) (Behavioral)

Relaxation with Educational Support

Active Comparator

Applied relaxation plus educational support (RES).

干预措施: Relaxation techniques and education about ADHD (Other)

结局指标

主要结局

Post-treatment ADHD Symptoms

时间窗: post-treatment (after receiving 12 sessions of treatment)

ADHD symptom severity as measured by the ADHD rating scale (DuPaul, et al., 1998) a scale that ranges from 0-54 with 0 indicating lower severity.

次要结局

  • Maintenance of Gains in CBT Condition(12 month follow-up (12 months after baseline assessment))

研究者

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

Steven A. Safren

Principal Investigator

National Institute of Mental Health (NIMH)

研究点 (2)

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