Comparing Cognitive Remediation Approaches for Schizophrenia
试验速览
- 阶段
- 不适用
- 入组人数
- 135
- 试验地点
- 4
- 主要终点
- Matrics Consensus Cognitive Battery score (MCCB composite score)
研究概览
简要总结
This research compares the relative efficacy of two empirically-supported, standardized programs of cognitive remediation for treatment of cognitive deficits and community function in schizophrenia to help inform best practices. The proposed study advances public health by developing and evaluating new behavioral techniques for improving psychosocial outcome in individuals diagnosed with schizophrenia.
详细描述
Evidence over the past 30 years has revealed that 70-80% of individuals with schizophrenia exhibit marked neurocognitive deficits on measures of attention, learning and memory, problem-solving, language and sensory-motor skill. Particular significance has been attached to these deficits as their severity has been linked to impaired community function, social problem-solving and progress in psychosocial rehabilitation programs. Cognitive remediation (CR) is a type of behavioral intervention that addresses cognitive deficits in schizophrenia by restoring lost cognitive skills or providing strategies for bypassing deficits through task practice. Meta-analyses have revealed that cognitive remediation is a validated approach to improving cognitive function in schizophrenia, however a lack of precision regarding the active elements of the intervention have prevented its recommendation as a standard treatment for the illness. The present three-year proposal seeks to identify cognitive training mechanisms that are most effective at improving cognitive function in schizophrenia by comparing two different systematic programs of CR with different foci: drill-and-practice exercises vs. compensatory strategies. Both programs have strong preliminary empirical support. One-hundred and thirty-five clients diagnosed with schizophrenia or schizoaffective disorder will be randomly assigned to one of three groups: a neuroplasticity-based, drill-and-practice program of computer-assisted cognitive training exercises designed to restore lost cognitive capacity; a manualized strategy training method for bypassing deficits in cognition, or a computer games control condition. Study measures, organized according to an experimental therapeutics approach, with targets distinguished from outcomes, will assess generalization of any observed training effects.
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 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Meeting DSM-5 criteria for schizophrenia or schizoaffective disorder, presenting for intensive outpatient clinical care.
- •Stabilized on atypical antipsychotic medication for a minimum of 2 months prior to entry into the protocol.
- •A minimum of 2 months since discharge from last hospitalization.
排除标准
- •Uncorrected auditory or visual impairment.
- •Mental retardation (Full Scale IQ<70, as estimated by single word-reading from the WRAT and/or evidence of a history of services).
- •Traumatic brain injury with loss of consciousness for more than 10 minutes.
- •Presence or history of any neurologic illness.
- •Lack of proficiency in English
- •Criteria met for concurrent substance dependence,
- •Scoring within 1SD of healthy control performance (from published norms) on measures of visual vigilance, verbal learning, and working memory.
结局指标
主要结局
Matrics Consensus Cognitive Battery score (MCCB composite score)
时间窗: Measures change from study entry, after 3-months of treatment and at a 3-month follow-up.
The MCCB includes state-of-the-art cognitive probes selected by 74 experts using the RAND panel method. The battery has strong reliability in schizophrenia and includes multiple forms for many subtests to help control for practice effects. Summary T-scores range from 20 to 80 with higher scores indicating better cognitive performance.
UCSD Performance-Based Skills Assessment
时间窗: Measures change from study entry, after 3-months of treatment and at a 3-month follow-up.
This standardized performance-based instrument of everyday function, with evidence of reliability and validity in schizophrenia samples, provides information regarding patients' ability to manage information/planning, finance, communications, mobility and household management in role-play situations.Scores range from 0-20 with higher scores indicating better functioning.
Quality of Life Scale
时间窗: Measures change from study entry, after 3-months of treatment and at a 3-month follow-up.
A 21-item scale commonly used as a measure of psychosocial functioning in schizophrenia. The Quality-of-Life Scale balances subjective questions regarding life satisfaction and objective indicators of social and occupational role functioning.Scores range from 0-42 with higher scores indicating better functioning.
次要结局
未报告次要终点
研究者
Matthew M. Kurtz
Professor
Wesleyan University