Cognitive Behavioural Therapy and Recreational Activity for Adults With Autism Spectrum Disorders. A Randomized Controlled Trial.
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 68
- 试验地点
- 2
- 主要终点
- The Quality of Life Inventory (QOLI, Frisch et al. 1992)
研究概览
简要总结
The purpose of this study is to determine if adults with autism spectrum disorder and with normal intelligence improve from 36 sessions (1 calendar year) of group treatment with Cognitive Behavioural Therapy or recreational activity in groups with 6-8 participants.
详细描述
The purpose of this study was to compare two group interventions for psychiatric patients with Autism spectrum disorder and normal intelligence: Cognitive Behavioural Therapy developed to suit adults with Autism spectrum disorder, and recreational activity, enabling social interaction. The recreational activity intervention served as a low-impact option, easily organised within the community. It is not a placebo; rather it controls for the positive effects that come out of a structured social environment and group setting. The investigators hypothesized that both interventions would lead to improvement in quality of life, well-being and relief in psychiatric symptoms, with a greater effect in the Cognitive Behavioural Therapy intervention compared to recreational activity. A cumulative follow-up was made, within 5 1/2 years after the start of the treatments. Additional questions adapted to the patient group were added at this 5 1/2 year time point.
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
- •Clinical diagnosis of autism spectrum disorders
- •Normal intelligence as assumed by mainstream schooling
- •Acceptance of a group setting
- •Being able to transport themselves to the clinic (with or without support)
排除标准
- •Current substance abuse
- •Current psychosis
结局指标
主要结局
The Quality of Life Inventory (QOLI, Frisch et al. 1992)
时间窗: Baseline, after 36 sessions (1 calendar year) and at a cumulative follow-up within 5 years after treatment termination
Changes in the Quality of Life Inventory from baseline.
Clinical Global Impression scale - Improvement (patient CGI-I)
时间窗: Before treatment (at baseline) and at a cumulative follow-up within 5 years after treatment termination
Patient rating on a seven-step Likert scale
Sense of Coherence (SoC, Antonovsky 1993)
时间窗: At baseline and after 36 sessions (1 calendar year)
Self-rating scale, change from baseline
The ten-item Rosenberg Self Esteem Scale (RSES, Rosenberg 1962)
时间窗: Before treatment (baseline) and after 36 sessions (1 calendar year)
This was used to measure self esteem, change from baseline.
The patient versions of the Clinical Global Impression scale - Severity (patient CGI-S)
时间窗: Before treatment and after 36 sessions (1 calendar year)
Severity of impairment at baseline rated by the patient. Change from baseline.
次要结局
- Autism Quotient (AQ, Baron-Cohen et al. 2001)(At baseline and after 36 sessions (1 calendar year))
- Adult ADHD Self-Report Scale (ASRS, Kessler et al. 2005)(At baseline and after 36 sessions (1 calendar year))
- Beck Depression Inventory (BDI, Beck et al. 1996)(At baseline and after 36 sessions (1 calendar year))
- Symptom Checklist 90 (SCL-90, Derogatis & Cleary 1977)(At baseline and after 36 sessions (1 calendar year))
研究者
Susanne Bejerot
Associate professor
Karolinska Institutet