A Randomized Controlled Study of Cognitive Behavioral Therapy for Adults With Attention Deficit Disorder
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 108
- 试验地点
- 1
- 主要终点
- Change in ADHD Rating Scale
研究概览
简要总结
The purpose of this study is to determine whether cognitive behavioral therapy (CBT) is effective in the treatment of attention deficit and emotional, executive function and social function dysregulation due to attention deficit disorder (ADHD).
详细描述
Participations will be randomly assigned to 3 groups which are CBT with booster sessions group, CBT only group and waiting group.With the comparison of first tow groups we will explore the effect of booster sessions, and the last two groups the effect of CBT programme.
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
- Triple (Participant, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 45 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Outpatients from Peking University Sixth Hospital
- •Diagnosis of adult ADHD based on Diagnostic and statistical manual of mental disorders, Fourth Edition (DSM-IV)
- •Stable on medications for adult ADHD for at least 2 months
排除标准
- •Severe major depression, clinically significant panic disorder, bipolar disorder, organic mental disorders, psychotic disorders, or pervasive developmental disorders
- •Intelligence Quotient (IQ) less than 90
- •Suicide risk
- •Unstable physical condition
- •Prior participation in cognitive behavioral therapy for ADHD or other psychological therapy
结局指标
主要结局
Change in ADHD Rating Scale
时间窗: Baseline, at the end of week 1, 2, 3, 4, 5, 6, 7, 8, 9, 10, and 11 in treatment, 12 weeks (post), 24 weeks (FU6), 36 weeks (FU9), and 48 weeks (FU12)
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
- Change in Conners Adult ADHD Rating Scale Self-report Screening Version (CAARS-S:SV)(Baseline, at the end of week 1, 2, 3, 4, 5, 6, 7, 8, 9, 10, and 11 in treatment, 12 weeks (post), 24 weeks (FU6), 36 weeks (FU9), and 48 weeks (FU12))
- Change in Self-rating depression scale (SDS)(Baseline, at the end of week 1, 2, 3, 4, 5, 6, 7, 8, 9, 10, and 11 in treatment, 12 weeks (post), 24 weeks (FU6), 36 weeks (FU9), and 48 weeks (FU12))
- Change in self-esteem scale (SES)(Baseline, 12 weeks (post), 24 weeks (FU6), and 48 weeks (FU12))
- Change in World Health Organization Quality of Life-Brief Version (WHOQOL-BREF)(Baseline, 12 weeks (post), 24 weeks (FU6), and 48 weeks (FU12))
- Change in Cambridge Neuropsychological Test Automatic Battery (CANTAB)(Baseline, 12 weeks (post), 24 weeks (FU6), and 48 weeks (FU12))
- Change in Barratt impulsiveness scale (BIS)(Baseline, 12 weeks (post), 24 weeks (FU6), and 48 weeks (FU12))
- Change in Brain Oxygenation Level Dependent (BOLD) Signal(Baseline, 12 weeks (post))
- Change in Self-Rating Anxiety Scale (SAS)(Baseline, at the end of week 1, 2, 3, 4, 5, 6, 7, 8, 9, 10, and 11 in treatment, 12 weeks (post), 24 weeks (FU6), 36 weeks (FU9), and 48 weeks (FU12))
- Change in Behavior Rating Inventory of Executive Function-Adult Version (BRIEF-A)(Baseline, 12 weeks (post), 24 weeks (FU6), and 48 weeks (FU12))
研究者
Qiujin Qian
PhD
Peking University Sixth Hospital