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临床试验/NCT00391677
NCT00391677已完成不适用

Effectiveness Trial of Attention Shaping for Schizophrenia

University of Medicine and Dentistry of New Jersey3 个研究点 分布在 1 个国家目标入组 120 人开始时间: 2007年1月最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
120
试验地点
3
主要终点
Observational ratings of in-group attentiveness

研究概览

简要总结

This study will evaluate the effectiveness of attention shaping procedures in improving attentiveness and learning abilities in people undergoing psychosocial skills training treatment for schizophrenia.

详细描述

Schizophrenia is a disabling mental disorder that can interfere with a person's ability to function both alone and in social situations. Various treatments have been effective in treating schizophrenia, including antipsychotic medications and cognitive therapy. Psychosocial skills training, a type of cognitive therapy, is often used to help people with schizophrenia cope with their condition and improve social functioning in day-to-day life. However, many individuals with schizophrenia experience difficulty paying attention, and this is a significant barrier to successful outcomes in psychosocial skills training interventions. Attention shaping procedures (ASP) is a behavioral intervention that helps individuals with impaired attention capacities to benefit from skills-based treatment. This study will evaluate the effectiveness of ASP in improving attentiveness and learning abilities in people undergoing psychosocial skills training treatment for schizophrenia.

Participants in this 5-month, single-blind study will be randomly assigned to ASP plus basic conversation skills training (BCS), which is a social skills training group, or BCS alone. Training sessions for both groups will be held when participants attend regular hospital visits. During the first month, participants will complete two sessions of interviews, self-report scales, and social and cognitive functional assessments. Over the next 3 months, training sessions for both groups will occur twice a week for approximately 1 hour. ASP sessions will focus on setting goals and increasing the quality and duration of participants' attentiveness during psychosocial interventions. BCS will train participants in the following five skill areas: recognizing verbal and non-verbal cues; starting a friendly conversation; keeping conversation going; ending a conversation politely; and incorporating all of these skills together. During the last month, participants will attend two interview sessions lasting approximately 4 hours each. One follow-up session will occur 6 months after completing the intervention.

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
Single (Outcomes Assessor)

入排标准

年龄范围
18 Years 至 55 Years(Adult)
性别
All
接受健康志愿者

入选标准

  • Diagnosis of schizophrenia, as confirmed by a diagnostic interview
  • Has experienced difficulty paying attention while in groups during a treatment program, as determined by program staff
  • Has experienced problems with social skills, as determined by program staff and study clinicians
  • Social skill deficits, as determined by study clinicians

排除标准

  • Diagnosis of mental retardation (including borderline or mild mental retardation)
  • Diagnosis of autism, Asperger's syndrome, or another childhood disorder involving learning or relating to other people
  • History of a neurological disorder, including epilepsy, traumatic brain injury with loss of consciousness, coma, stroke, Parkinson's disease, etc.
  • Diagnosis of active substance abuse (history of a substance abuse disorder without a current substance abuse problem will not be a criterion for exclusion)

结局指标

主要结局

Observational ratings of in-group attentiveness

时间窗: Measured two times per week for 16 weeks

Observational ratings of in-group attentiveness in non-study groups

时间窗: Measured at Month 6 follow-up

Changes in knowledge of information about social skills taught in the study

时间窗: Measured at pre- and post-treatment and at Month 6 follow-up

Changes in ability to demonstrate behavioral skills taught in the study

时间窗: Measured at pre- and post-treatment and at Month 6 follow-up

Level of social functioning

时间窗: Measured at pre- and post-treatment and at Month 6 follow-up

次要结局

  • Self-efficacy(Measured at pre- and post-treatment and at Month 6 follow-up)
  • Working alliance(Measured at pre- and post-treatment and at Month 6 follow-up)
  • Satisfaction with treatment(Measured at pre- and post-treatment and at Month 6 follow-up)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (3)

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