E-SMART: Examining Strategy Monitoring and Remediation Training for Schizophrenia
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 90
- 试验地点
- 2
- 主要终点
- Specific Levels of Functioning Scale
研究概览
简要总结
Executive Function Training is a cognitive training approach that specifically trains executive functioning for people with schizophrenia-spectrum disorders. The current study compares full executive function training to computerized training alone and to strategy monitoring alone.
详细描述
All interventions will involve 4 weeks of group treatment consisting of two 1-hour group sessions per week and additional practice at home between sessions. The Executive Training condition will consist of 50% of the session practicing computerized cognitive training exercises, and 50% of the session developing cognitive strategies to use in the computerized exercises. Participants are encouraged to complete 40 minutes of computerized training per day, and complete strategy worksheets, at home between sessions. In Computerized Cognitive Training only participants will spend the entire one-hour session practicing computerized training exercises. Between sessions participants will be encouraged to practice the computerized exercises at home for 40 minutes per day. There will be no strategy development in this condition. In Strategy Development only participants will engage in cognitive strategy discussions to develop new executive function strategies that can be used in daily life. Between sessions, participants will be encouraged to practice their cognitive strategies in their daily life and track their strategies using the strategy worksheet. There will be no computerized cognitive training in this condition. All interventions will be delivered virtually in the participant's home and group sessions will be conducted using the online platform Zoom.
90 participants with schizophrenia-spectrum disorders will be recruited. Power analyses, conducted with GPower, indicate that 90 participants (30 per treatment condition), accounting for an upper limit of 25% attrition observed in my previous trials of ET, provides 80% power to detect a medium effect size (cohen's f = 0.2) difference between conditions.
Primary and secondary outcomes will be examined using Linear Mixed Models on the Intent-to-Treat sample with missing data interpolated using maximum likelihood estimation. The primary endpoint is the 3-month follow-up assessment, and secondary endpoint of post-treatment will also be examined.
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
- Double (Participant, Outcomes Assessor)
盲法说明
Participants will be informed that they will be randomized to one of three types of cognitive training, however, will have no idea what the conditions or the hypotheses. Outcome assessors will be blind to condition.
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
- •clinical diagnosis of schizophrenia, schizoaffective disorder or any other psychotic disorder (based on DSM-V)
- •18-65 years of age
- •know how to use a computer
- •not abusing drugs or alcohol
- •can read and speak English.
排除标准
- •enrolled in a cognitive training program in the last 6 months
- •neurological disease or neurological damage
- •medical illnesses that can change neurocognitive function
- •medical history of head injury with loss of consciousness
- •physical handicaps
结局指标
主要结局
Specific Levels of Functioning Scale
时间窗: Change from Baseline to 12-Week Follow-up
The SLOF is a behavioral questionnaire assessing community functioning. It includes 43 items, grouped into six subscales: Physical functioning; Personal care skills; Interpersonal relationships; Social acceptability; Activities of community living; and Work skills. Each of the 43 questions in the above subscales is rated on a 5-point Likert scale (1 = poorest function, 5 = best function) with anchors describing the frequency of the behavior and/or patient's level of independence. The higher the total score, the better the overall functioning of the individual. Scores range from 43 - 215.
次要结局
- Motivation and Pleasure Scale - Self-Report (MAP-SR)(Change from Baseline to 12-Week Follow-up)
- Generalized Self-Efficacy Scale (GSES)(Change from Baseline to 12-Week Follow-up)
- Need for Cognition Scale (NCS)(Change from Baseline to 12-Week Follow-up)
- Cognitive Failures Questionnaire (CFQ)(Change from Baseline to 12-Week Follow-up)
- Cambridge Neuropsychological Test Automated Battery (CANTAB)(Change from Baseline to 12-Week Follow-up)
- Wide Range Achievement Test (WRAT)(Change from Baseline to 12-Week Follow-up)
- Questionnaire About the Process of Recovery (QPR)(Change from Baseline to 12-Week Follow-up)
- Quality of Life Enjoyment and Satisfaction Questionnaire (Q-LES-Q)(Change from Baseline to 12-Week Follow-up)
- Dysfunctional Attitudes Scale (DAS)(Change from Baseline to 12-Week Follow-up)
- Brief Core Schema Scale (BCSS)(Change from Baseline to 12-Week Follow-up)
- Davos Assessment of Cognitive Biases (DACOBS)(Change from Baseline to 12-Week Follow-up)
- Brief Psychiatric Rating Scale (BPRS)(Change from Baseline to 12-Week Follow-up)
研究者
Michael Best
Assistant Professor
University of Toronto