Cognitive Remediation in Late-Life Schizophrenia

赞助:

合作者:

信息的提供 (责任方):

Angela Golas，Centre for Addiction and Mental Health

追踪信息

首次提交日期 ^ICMJE

September 3, 2018

首次发布日期e ^ICMJE

October 4, 2018

最后更新发布日期

October 4, 2018

预计研究开始日期 ^ICMJE

October 2018

预计主要完成日期

September 2020 (主要结果测量的最终数据收集日期)

目前主要观察指标 ^ICMJE

Assess the effect of CR on cognitive performance as indicated by total Montreal Cognitive Assessment (MoCA) scores[ Time Frame: approximately 12 weeks after the baseline ]

Total score out of 30 possible points, with 30/30 indicating best possible score

原始主要观察测量 ^ICMJE

与当前相同

目前的二级观察 ^ICMJE

Assess effect of Cognitive Remediation (CR) on tolerability of CR according to the percentage of participants completing the 12-week course[ Time Frame: approximately 12 weeks after the baseline ]
Range of 0-100% individuals completing, with 100% completers indicating best possible outcome.
Change in general, positive, and negative symptoms of Schizophrenia as assessed by the Positive and Negative Syndrome Scale[ Time Frame: At baseline and approximately 12 weeks after the baseline ]
Total score range of 30-210, 30 indicating the best possible score
Change in depressive symptoms as assessed by the Calgary Depression Scale for Schizophrenia[ Time Frame: At baseline and approximately 12 weeks after the baseline ]
Score range of 0-27, 0 indicating the best possible score
Change in cognition as assessed by the Montreal Cognitive Assessment[ Time Frame: At baseline and approximately 12 weeks after the baseline ]
Score range of 0-30, 30 indicating best possible score
Change in visuospatial/executive domains of cognition as assessed by the Trail making Test B and A[ Time Frame: At baseline and approximately 12 weeks after the baseline ]
Scored via number of correct moves ranging from 0-24, 24 indicating best possible score. Also scored via number of errors made, ranging from 0-24, 0 indicating best possible score
Change in immediate memory, visuospatial/constructional cognition, language, attention, and delayed memory as assessed by the Repeatable Battery for the Assessment of Neuropsychological Status (RBANS)[ Time Frame: At baseline and approximately 12 weeks after the baseline ]
Subscales include List Learning (0-40, 40 indicating best possible score) and Story Memory (0-24, 24 indicating best possible score) for testing of immediate memory. Figure Copy (0-20, 20 indicating best possible score) and Line Orientation (0-20, 20 indicating best possible score) for testing of visuospatial/constructional cognition. Picture Naming (0-10, 10 indicating best possible score) and Semantic Fluency (4-40, 40 indicating best possible score) for testing of language. Digit Span (0-16, 16 indicating best possible score) and Coding (0-89, 89 indicating best possible score) for testing of attention. List Recall (0-10, 10 indicating best possible score), List Recognition (0-20, 20 indicating best possible score), Story Recall (0-12, 12 indicating best possible score), and Figure Recall (0-20, 20 indicating best possible score) for testing of delayed memory.
Change in executive functioning and planning ability as assessed by the Tower of London[ Time Frame: At baseline and approximately 12 weeks after the baseline ]
Change in executive functioning and planning ability as assessed by the Tower of London
Change in verbal working memory as assessed by the Letter Number Span[ Time Frame: At baseline and approximately 12 weeks after the baseline ]
Score range of 0-24, 24 indicating best possible score
Change in visual working memory as assessed by the Wechsler Memory Scale Spatial Span[ Time Frame: At baseline and approximately 12 weeks after the baseline ]
Scored via number of correct forward items (0-16, 16 indicating best possible score). Also scored via number of correct backwards items (0-16, 16 indicating best possible score)
Degree of anticholinergic burden of medication used by our participants, quantified by the Anticholinergic Burden Scale (ACB)[ Time Frame: At baseline ]
A total ACB scale score of three or more is considered clinically relevant

描述性信息

简略标题 ^ICMJE

Cognitive Remediation in Late-Life Schizophrenia

正式标题 ^ICMJE

Cognitive Remediation in Late-Life Schizophrenia

简要概况

Cognitive Remediation (CR) involving restorative and strategy-based methods has been previously validated in a pilot study for late life schizophrenia (LLS), where CR demonstrated a moderate effect on overall cognition. This study proposes to study the efficacy of CR in a larger cohort of participants with LLS and to assess the interaction of medication management with CR on cognitive outcomes. Eligible participants will receive CR during 12 weeks. CR consists of a series of computerized exercises targeting various cognitive functions, such as memory, attention and processing speed. It will be administered during facilitated group sessions consisting of 4-6 people. The study aims to enroll 30 LLS participants age 55 or older who will undergo the CR intervention for two, 2-hour weekly classes over 12 weeks (24 classes in total). There will be baseline assessments (clinical and NP) prior to enrollment in the classes. In order to assess whether there has been a change in cognition, and some of the assessments will be repeated after the 12-week intervention.

详细说明

Thirty late life schizophrenia (LLS) participants, age 55 and over, will undergo the CR intervention after completion of the baseline assessments. CR is a group-based psychotherapy that will consist of two, 2-hour weekly therapist-guided classes over 12 weeks, with a half-hour lunch break. The 24 classes are divided into two iterations of 12 exercises each, repeated twice. CR consists of four techniques: (1) didactic teaching on the relevance of cognition for everyday functioning and the association between cognitive strategies and enhanced functioning (2) computerized drills targeting different cognitive domains, (3) in-class strategic monitoring to enhance metacognitive skills, and (4) discussion of the generalization of cognitive skills to daily life. The Brain Gym includes electronic tablets for participant use both during classroom sessions in addition to elective, drop-in practice sessions offered three times per week. Each group will consist of 4-6 participants. A group will be started once four to six consecutively referred participants complete baseline assessments. Each class is self-contained and the first class is always introductory to CR in order to enhance the comfort level with the computer equipment and program. Each of the 24 classes will have one, 5-10 minute block of didactic teaching, two 45-minute blocks of drill-and-practice of the online exercises, and a 20-minute lunch break. Exercises are delivered via Scientific Brain Training (SBT) Pro (2009). Computer exercises are designed to be enjoyable and reinforcing, with the difficulty level gradually increasing over time. The therapists optimize competency and motivation by individualizing the exercises for each participant. The difficulty level parameters are manually titrated according to exercise adherence and difficulty level progression, targeting 80 percent accuracy in order to optimize competency and motivation. In order to optimize learning and retention outside of weekly classes, participants are encouraged to return to the computer lab for ongoing practice of the online exercises, targeting 40 minutes of homework exercises per weekday for a total target of 200 minutes per week. Online logs allow for monitoring the time spent completing the computer exercises. The therapists review the online logs on a weekly basis with the participants at the end of the didactic class and before planning the homework for the following week. Participants' successful completion of a given exercise to the highest difficulty level is charted in the Brain Gym using their anonymized computer log-in name to serve as positive reinforcement and recognition of their achievement while maintaining privacy.

研究类型 ^ICMJE

Interventional

研究阶段

N/A

研究设计 ^ICMJE

分配:
干预模型: Single Group Assignment
干预模型描述:
盲法: Interventional
盲法描述:
主要目的: Treatment

适用条件 ^ICMJE

干预项目 ^ICMJE

Other: Cognitive Remediation Therapy
Cognitive Remediation is a well-established psychotherapy that aims to improve neurocognitive abilities such as memory performance, executive functioning, processing speed, and attention.

研究工具

Experimental: Cognitive Remediation

招募信息

招募状态 ^ICMJE

Recruiting

预计入组 ^ICMJE

原始预计入组 ^ICMJE

与当前相同

预计研究完成日期

December 2020

预计主要完成日期

September 2020 (主要结果测量的最终数据收集日期)

合格标准 ^ICMJE

Inclusion Criteria: 1. Age 55 years and above. The rationale of age cutoff of 55 is that this age is considered a typical geriatric age cutoff for participants with LLS. 2. Any race or ethnicity. 3. Females and males. 4. Meets DSM-V criteria for a current diagnosis of schizophrenia or schizoaffective disorder. 5. Clinically stable as operationalized by (1) having not been admitted to a psychiatric hospital within the 3 months prior to assessment, (2) having had no change in antipsychotic medication dosage within the 4 weeks prior to assessment, and (3) and ascertained to be clinically and medically stable by one of the study psychiatrists. 6. Willingness and ability to speak English 7. Willingness to provide informed consent 8. Corrected visual ability that enables reading of newspaper headlines and corrected hearing capacity that is adequate to respond to a raised conversational voice. Exclusion Criteria: 1. Meets criteria for a cognitive disorder secondary to a neurological or other medical disorder 2. Diagnosis of bipolar disorder or current major depressive episode 3. Meets diagnostic criteria for substance use or dependence within the 6 months prior to the initial assessment except for caffeine or nicotine 4. Electroconvulsive Therapy (ECT) within 6 months of initial assessment

性别

参与研究的性别:

All

年龄

最小年龄：55 Years ，最大年龄：N/A

接受健康的志愿者

没有

可入组国家 ^ICMJE

Canada

管理信息

数据检测委员会

研究涉及美国FDA监管的产品

研究美国FDA监管的药品: No
研究涉及美国FDA监管的设备产品: No

IPD 共享声明

计划分享 IPD:

责任方

Angela Golas，Centre for Addiction and Mental Health

研究赞助商 ^ICMJE

Centre for Addiction and Mental Health

合作者 ^ICMJE

研究员 ^ICMJE

Principal Investigator: Angela Golas, MD Centre for Addiction and Mental Health

PRS 账户

Centre for Addiction and Mental Health

验证日期

September 2018

^ICMJE 国际医学期刊编辑委员会和世界卫生组织 ICTRP 要求的元素

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