Effects of Structured Skills Training Group in Treatment of ADHD in Adults: a Controlled Multicentre Study
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 120
- 试验地点
- 2
- 主要终点
- Behaviour Rating Inventory of Executive Functions (BRIEF)
研究概览
简要总结
This study aims to examine if structured skills training group therapy for ADHD in adults has beneficial effects superior to 'treatment as usual' including medication in a controlled outpatient setting on clinically relevant outcomes including symptoms, functioning and quality of life measures.
The trial is designed as a multicenter randomized controlled, parallel group study. Patients are randomized into 1 of 2 treatment arms with 14-week duration: one arm with initial intervention by structured skills training groups by weekly sessions or one with control condition (treatment as usual). Then after 15 weeks patients in the control condition arm are switched to the active intervention by 14 weeks of structured group therapy. All patients are assessed for defined outcomes after six months.
详细描述
Background: The focus in recent years on evidence for non-pharmacological treatment in adults with ADHD raises the question of potential effects of structured group therapy. Structured skills training groups have shown beneficial effects in some studies in an outpatient psychiatric context by reduction in ADHD symptoms in individuals who remained stable regarding medication status.
Aims: The main objective for the trial is to investigate the potential effects of structured skills training groups in a clinically relevant but still controlled setting on broader outcomes including both symptomatic, functional and health related quality of life measures.
Methods/Design: The trial is designed as a multicenter randomized controlled parallel group design. At each outpatient site the enrolled patients are randomized into two groups for either Group 1 (G1) with start of weekly treatment in active structured skills training group lasting for 14 weeks or allocated to Group 2 (G2) with treatment as usual/clinical management and with 15 weeks delayed start of their group treatment for comparison wth patients in the other arm. Those patients in the control condition arm receiving treatment as usual or clinical management of individual patients (G2), are thereafter switched to active structured skills training group therapy.All patients are followed up after six months with assessments of primary and secondary outcomes.
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 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Diagnosis of ADHD according to the Diagnostic and Statistical Manual of Mental Disorders, 4th. Edition (DSM-IV) persisting in adulthood
排除标准
- •Any psychotic disorder
- •Recently suicidal behaviour
- •Substance or alcohol abuse or dependence within three months prior to screening for inclusion
- •Pervasive developmental disorder
- •Intellectual disability
- •Seizures or any neurological diseases causing mental handicap
研究组 & 干预措施
Initial group therapy
'Structural skills training group' - Start up with weekly structured skills training group for 14 weeks supplemented by homework training
干预措施: Structural skills training group (Behavioral)
Initial control condition
Treatment as usual/clinical management the first 15 weeks pending deferred start of group therapy (partially cross-over)
干预措施: Treatment as usual (Other)
结局指标
主要结局
Behaviour Rating Inventory of Executive Functions (BRIEF)
时间窗: two years
Change in executive function impairments
次要结局
- Adult ADHD self-report scale (ASRSv1.1), 18 items version(two years)
- Beck Depression Inventory (BDI)(two years)
- Beck Anxiety Inventory (BAI)(two years)
- Weiss Functional Impairment Rating Scale, self-report (WIFRS)(two years)
- Global Assessment of functioning (GAF)(two years)
- Adult ADHD Quality of Life Scale (AAQoL)(two years)
- Difficulties in Emotion Regulation Scale (DERS)(two years)
- Safety issue - Monitoring of adverse events(two years)
研究者
Mats Fredriksen
Chief Attending Physician
University of Oslo