Computerized Cognitive Skills Training in Severe Mental Illness
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 入组人数
- 448
- 试验地点
- 2
- 主要终点
- Measurement and Treatment Research to Improve Cognition in Schizophrenia (MATRICS)
研究概览
简要总结
The study is designed to evaluate the effectiveness of computerized cognitive skills training for improving memory and problem-solving skills in inpatients with schizophrenia.
详细描述
Subjects are stable inpatients and outpatients with schizophrenia or schizoaffective disorder who are receiving atipsychotic medication at Manhattan Psychiatric Center.
Patients receive baseline assessments (MCCB-MATRICS; Personal and Social Performance Scale, FEDT/FEIT and PANSS) and then are assigned to Cognitive Remediation (CRT) using the COGPACK program, patients are then randomly assigned to a social cognition program (Mind Reader Interactive Guide to Emotions) for a period of 12 weeks. Following 12 weeks of treatment in either CRT + Mind Reader or CRT alone, assessments are repeated by raters.
Cognitive Remediation (CRT): CRT (COGPACK, Marker and Olbrich, 1998) consists of computerized practice tests for seven cognitive domains. There are 64 programs for testing and training, each with several variants for the domains of visuomotor skills, comprehension, reaction, vigilance, memory, language, and intellectual skills. Exercises in COGPACK can be edited and expanded. Patients attend 2 (45-minutes each) groups and 1 discussion group.
Social Cognition Training: Mind Reader (Baron-Cohen et al, 2004) is an interactive computerized program of emotions and mental states. It is based on a taxonomic system of 412 emotions and mental states, grouped into 24 emotion groups, and six developmental levels (from age 4 to adulthood). The emotions and mental states are organized systematically, according to the emotion groups and developmental levels. Patients assigned to Mind Reader attend 1 group per week.
Both the CRT and Mind Reader are administered in small groups of six to eight patients each.
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)
盲法说明
Raters were blind to the type of interventions
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
- •Age 18 and above;
- •In- and out-patients;
- •DSM-IV diagnosis of schizophrenia (all subtypes) or schizoaffective disorder with illness duration >5 years;
- •Auditory and visual acuity adequate to complete cognitive tests;
- •Stable dose of oral atypical antipsychotic for at least 4 weeks;
- •Total PANSS score > 60;
- •Good physical health determined by physical examination from medical chart review;
- •Capacity and willingness to give written informed consent.
排除标准
- •Inability to read or speak English;
- •Documented disease of the central nervous system;
- •History of intellectual impairment pre-dating onset of symptoms of psychosis (e.g. mental retardation);
- •Clinically significant or unstable cardiovascular, renal, hepatic, gastrointestinal, pulmonary or hematological conditions;
- •Patients diagnosed with substance dependence;
- •Currently participating in another experimental study.
研究组 & 干预措施
Computerized Cognitive Remediation
Two arms: 1. Computerized Cognitive Remediation treatment using COGPACK. and 2. PositScience. Each arm is further randomized to either MindReader or no Mindreader.(Social Cognition Training).
干预措施: Computerized Cognitive Skill Training (Behavioral)
CRT + Social Cognition Training
Two 45-minute sessions of Computerized Cognitive Remediation using COGPACK, one 45-minute discussion session, plus one 45 minute Mind Reader Interactive Guide to Emotions per week for 12 weeks. compared to two 45-minute sessions of PositScience, plus one 45-min Discussion session plus one minute of Mind Reader, Interactive Guide to Emotions
干预措施: CRT and Social Cognition (Behavioral)
结局指标
主要结局
Measurement and Treatment Research to Improve Cognition in Schizophrenia (MATRICS)
时间窗: Week 0, and Week 12 (after completion of Cognitive Remediation)
Comprehensive battery of neuro-cognitive tests
次要结局
- Facial Emotional Discrimination Task (FEDT) and Facial Emotional Identification Task (FEIT)(Week 0, and Week 12 (after compeltion of Cognitive Remediation))
- Personal and Social Performance Scale (PSP)(Week 0, and Week 12 after completion of Cognitive Remediation)
- Positive and Negative Syndrome Scale (PANSS)(Week 0, Week 6 (Midpoint) and Week 12 after completion of Cognitive Remediation)
研究者
Jean-Pierre Lindenmayer
Director of Research
Nathan Kline Institute for Psychiatric Research