A Study of the Effectiveness of Cognitive Adaptation Training in Early Intervention for Psychosis
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 67
- 试验地点
- 1
- 主要终点
- Change in Adaptive Functioning (SOFAS)
研究概览
简要总结
The proposed study will involve a randomized trial of Cognitive Adaptation Training (CAT) for early intervention as compared against an active control in which Action Based Cognitive Remediation (ABCR) will be applied.
详细描述
The proposed project will expand knowledge of the role of compensatory and restorative cognitive interventions for early intervention population individuals with schizophrenia. The investigators will conduct a two arm randomized trial comparing the impacts of CAT and Action Based Cognitive Remediation (ABCR) for individuals with schizophrenia who are under the age of 30. The model would mirror the investigators' preliminary work at CAMH (Kidd et al., 2014) in which there will be 4 months of specialist-delivered treatment followed by 5 months of maintenance by case managers with pre, 4 month, and 9 month evaluations conducted. This study will be among the most rigorous examinations of such interventions to date, would be among the first to examine integrative approaches, and would make a substantial contribution to the early intervention literature.
The questions for the purposes of this project are:
- Is CAT effective among individuals with schizophrenia under the age of 30?
and 2. Does integrating cognitive remediation with CAT enhance outcomes as compared with CAT alone?
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
- 16 Years 至 29 Years（Child, Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Participants must be CAMH clients, have an assigned caseworker, be between the ages of 16-34 and have a psychosis such as schizophrenia or schizoaffective disorder.
排除标准
- •not currently experiencing high level of paranoia.
研究组 & 干预措施
Cognitive Adaptation Training
Cognitive Adaptation Training (CAT) is a standardized approach to the use of environmental supports for improving multiple domains of adaptive functioning including adherence to medication, grooming, and activities of daily living in patients with schizophrenia.
干预措施: Cognitive Adaptation Training (Behavioral)
Action Based Cognitive Remediation
ABCR is applied in once weekly 2 hour sessions in small groups (6-8 per group). In these group sessions, simulated bridging activities are done immediately following computerized cognitive activation to increase the chance that participants retain the strategies just developed in a real life environment.
干预措施: Action Based Cognitive Remediation (Behavioral)
结局指标
主要结局
Change in Adaptive Functioning (SOFAS)
时间窗: Change from baseline to 4 months and 9 months
A global level of social and occupational functioning will be obtained using the Social and Occupational Functioning Scale from the DSM-IV (American Psychiatric Association, 2000). The SOFAS rates global functioning on a scale from 0 to 100. The rating does not take into account level of symptomatology.
Change in Adaptive Functioning (SFS)
时间窗: Change from baseline to 4 months and 9 months
The Social Functioning Scale (SFS; Birchwood et al., 1990) will be administered. This is a self-report measure that details the frequency and intensity with which the person engages in functional activities. A total score and domain scores for social withdrawal, relationships, social activity, recreational activity, independence (competence), independence (performance) and employment are generated.
change in Adaptive Functioning (MCAS)
时间窗: Change from baseline to 4 months and 9 months
Both client and clinician versions of 17-item The Multnomah Community Ability Scale (MCAS, Barker et al., 1994) will be used to assess functionality.
次要结局
- Medication Adherence(Throughout the 9 months of participation.)
- Hospitalization(Throughout the 9 months of participation.)
- Change in Goal Attainment (GAS)(Change from baseline to 4 months and 9 months)
- Change in Caregiver Burden (IEQ)(Change from baseline to 4 months and 9 months)
- Change in Cognition (WRAT-III)(Change from baseline to 4 months and 9 months)
- Change in Cognition (Trail Making test part A)(Change from baseline to 4 months and 9 months)
- Change in Cognition (Digit Span Subtest of the Weschler Adult Intelligence Scale - III )(Change from baseline to 4 months and 9 months)
- Change in Cognition (CVLT)(Change from baseline to 4 months and 9 months)
- Change in Cognition (Trail Making Test, Part B, and the Wisconsin Card Sorting Test)(Change from baseline to 4 months and 9 months)
- Change in Positive symptoms (BPRS-E)(Change from baseline to 4 months and 9 months)
- Change in Negative symptoms (NSA)(Change from baseline to 4 months and 9 months)
研究者
Sean Kidd
Clinician Scientist
Centre for Addiction and Mental Health