Computerised Working Memory Training in Adults With ADHD: A Randomised Controlled Trial
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 102
- 试验地点
- 2
- 主要终点
- Change in a composite measure of working memory capacity
研究概览
简要总结
The purpose of this study is to evaluate whether computerised working memory training improves cognitive performance, ADHD symptoms, psychosocial functioning and quality of life in adults with ADHD, from psychiatric outpatient clinics (N=100) as well as from a high-security prison facility (N=50).
详细描述
The primary aim is to evaluate whether 5 weeks of computerised working memory training improves working memory capacity. Secondary aims are to explore whether improvements in working memory capacity will be transferred to improvements in learning abilities and fluid intelligence. Also, far transfer effects on executive functioning, ADHD symptoms, psychosocial functioning and quality of life will be explored. Finally, it will also be assessed to what extent improvements gained from 5 weeks of working memory training will be maintained 3 and 6 months post-study, respectively.
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
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
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
- 否
入选标准
- •Confirmed ADHD according to DSM-IV criteria; ADHD combined type, ADHD inattentive type or ADHD UNS, primarily inattentive type.
- •Unmedicated for ADHD during the course of the trial, or being under stable ADHD medication for at least one month at baseline visit and without any planned changes in medication until post-study assessments have taken place.
排除标准
- •Previous participation in computerised working memory training (completed training).
- •Any psychiatric disorder that in the judgment of the investigator, may interfere with study participation and/or study assessments, also including current substance abuse.
- •Participation in psychological treatment addressing ADHD during the course of the 5-week training period (psychoeducation is accepted).
- •Initiation of psychological treatment for coexistent disorders during the course of the study (treatment already ongoing at baseline visit is accepted if there are no planned changes during the 5-week training period).
结局指标
主要结局
Change in a composite measure of working memory capacity
时间窗: Baseline and 7 weeks
The composite measure of working memory capacity comprises the sum score of: * Digit Span score (forwards/backwards) * Span Board score (forwards/backwards) * Arithmetics score * Spatial Working Memory score
次要结局
- Change in Digit Span Forwards/Backwards score(Baseline, 7 and 31 weeks)
- Change in Arithmetics score(Baseline, 7 and 31 weeks)
- Change in Qbtest scores(Baseline, 7 and 31 weeks)
- Change in a composite measure of working memory capacity(Baseline and 31 weeks)
- Change in EuroQol- 5 Dimensions (EQ-5D) questionnaire(Baseline, 7, 19, and 31 weeks)
- Montgomery Åsberg Depression Rating Scale-Self report (MADRS-S)(Baseline and 7 weeks)
- Change in Span Board Forwards/Backwards score(Baseline, 7 and 31 weeks)
- Change in Spatial Working Memory score(Baseline, 7 and 31 weeks)
- Change in Sheehan Disability Scale (SDS)(Baseline, 7, 19, and 31 weeks)
- Change in Raven´s Standard Progressive Matrices score(Baseline, 7 and 31 weeks)
- Change in Adult ADHD Self-Report Scale (ASRS-v1.1) Symptom Checklist(Baseline, 7, 19, and 31 weeks)
- Change in Adult ADHD Quality of Life Measure (AAQoL)(Baseline, 7, 19, and 31 weeks)
- Adverse events(Baseline and 7 weeks)
研究者
Ylva Ginsberg, MD, PhD
Senior consultant psychiatrist, clinical postdoc
Karolinska Institutet