NEUROCOM: Cognitive Training for Patients With First Episode Schizophrenia
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 发起方
- Neurocom
- 入组人数
- 117
- 试验地点
- 2
- 主要终点
- USCD Performance-Based Skills Assessment
研究概览
简要总结
The study examines the effect of cognitive training on cognitive functioning and everyday competencies of patients with schizophrenia.
120 patients are expected to be included in this randomized controlled trial running at two sites in Denmark starting January 2007 The effect of a 16-week, manualized program of cognitive training integrated in a comprehensive psychosocial treatment (OPUS) for first-episode schizophrenia patients is compared with the effect of standard treatment (OPUS). A six month follow-up assessment is conducted to investigate a possible long-term learning effect of cognitive training.
Blinded assessments include the MATRICS Consensus Cognitive Battery and a co-primary outcome measure of cognitive improvement: A translated version of the UCSD Performance-based Skills Assessment (UPSA) adjusted to a Danish context.
The cognitive training consists of four modules focusing on the domain of attention, executive functioning, learning and memory. Module 1 and 2 are based on computer-assisted training tasks, and the following modules focus on more practical everyday tasks and calendar training. Cognitive training takes place twice a week and every other week the patient and trainer engage in a dialogue on the patient's cognitive difficulties, motivational goals and his/her progress in competence level.
The use of errorless learning principles, scaffolding and attentional externalisation aims at improving the patients' performance on cognitive and everyday tasks by learning to apply compensation techniques as well as limiting dysfunctional uses of available cognitive ressources (i.e. excessive self-focus, rumination).
The study will provide MATRICS Consensus Cognitive Battery results from a relatively large Danish sample of first-episode schizophrenia and contribute with valuable normative data on the UPSA.
It is hypothesized that cognitive training integrated in OPUS treatment enhances both cognitive and everyday competence of patients more than OPUS treatment alone. Expectations are that cognitive training will demonstrate a small to moderate effect on cognitive functioning and a moderate effect on everyday functioning as measured with the UPSA. Moreover, patients allocated to cognitive training are expected to show an improvement in self-esteem.
详细描述
Neurocognition and competence in schizophrenia A randomized controlled trial of cognitive training (CT) integrated in OPUS treatment versus OPUS treatment-as-usual
The presence of cognitive deficits in schizophrenia It is a well-established fact that cognitive deficits play a major role in functional outcome in schizophrenia (Keefe et al, 2006; Gold, 2004). Up to 85 % patients demonstrate cognitive dysfunctions in the range of 1½-2 SD below norm (Fagerlund, 2004; Corrigan & Penn, 2001; Heinrichs & Zankanis, 1998). Cognitive dysfunctions associated with schizophrenia involve attention, information processing, memory, and executive functions leading to difficulties in learning and poor problem solving abilities.
Evidence for the effect of rehabilitation on everyday competencies In spite of the severely debilitating cognitive dysfunctions, a relatively large number of patients have shown themselves capable of acquiring new abilities (e.g. Kern et al, 2005; Sartory et al, 2005; Ueland & Rund, 2004; Krabbendam & Aleman, 2003, Pilling et al, 2002, Harvey & Sharma, 2001; Tsang & Pearson, 2001, Danion et al, 2001, Bell et al, 2003, Wykes et al, 1999, 2003). Research has shown that training in symptom handling, social proficiency training, and supportive provisions in occupational relations apparently can help patients with schizophrenia to function in their daily lives, learn solving concrete practical and social tasks, and manage relatively independently. These improvements enhance self-esteem.
Effect studies of cognitive rehabilitation A Cochrane review done by Hayes & McGrath (2000) include three small randomized controlled trials and fails to provide conclusive data on evidence for or against cognitive training as a treatment for schizophrenia.
Krabbendam & Aleman's review (2003) of 12 controlled studies finds a weighted mean effect size (Cohen's d) of 0.45 with 95% CI, 0.26-0.64), which indicates a small to moderate effect of cognitive training (CT) for patients with schizophrenia.
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 35 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age between 18-35 years,
- •First-episode schizophrenia og schizotypal disorder in ICD-10,
- •Post-acute phase of illness,
- •Sufficient comprehension of Danish,
- •Written informed consent
排除标准
- •Rejection of participation,
- •Organic disorder,
- •Misuse of psychoactive drugs
结局指标
主要结局
USCD Performance-Based Skills Assessment
时间窗: 2009
次要结局
未报告次要终点