A Randomised Clinical Trial Examining Cognitive Remediation Plus Standard Treatment Versus Standard Treatment in Participants at Ultra-High Risk of Psychosis. - Effect on Cognitive Functioning, Functional Outcome and Symptomatology.
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 146
- 试验地点
- 2
- 主要终点
- Brief Assessment of Cognition in Schizophrenia (BACS)
研究概览
简要总结
Cognitive deficits are known to be a core feature of schizophrenia and seem to become manifest in the prodromal or Ultra-High Risk (UHR) state of psychosis. The cognitive deficits are known to pose a critical barrier to functional recovery. Hence it is of vital importance to find intervention strategies that can alleviate these cognitive deficits and consequently improve daily functioning, and quality of life, as well as the prognosis for UHR-patients. The investigators will examine whether:
- Cognitive remediation therapy will be superior to standard treatment in improving cognitive functioning in UHR- patients (null hypothesis: No difference between the two groups).
- Cognitive remediation therapy will be superior to standard treatment in improving psychosocial functioning and clinical symptoms in UHR-patients (null hypothesis: No difference between the two groups).
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 (Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 40 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age 18-40 yrs.
- •Fulfill criteria for being at Ultra-High Risk of psychosis (defined by one or more of the following):
- •Vulnerability (Trait and State Risk Factor) Group: Individuals with a combination of a trait risk factor (schizotypal personality disorder or a family history of psychotic disorder in a first degree relative) and a significant deterioration in functioning, or sustained low functioning during the past year.
- •Attenuated Psychotic Symptoms (APS) Group: Individuals with sub-threshold (intensity or frequency) positive psychotic symptoms. The symptoms must have been present during the past year.
- •Brief Limited Intermittent Psychotic Symptoms Group (BLIPS): Individuals with a recent history of frank psychotic symptoms that resolved spontaneously (without antipsychotic medication) within one week. The symptoms must have been present during the past year.
- •Provided informed consent.
排除标准
- •Past history of a treated or untreated psychotic episode of one week's duration or longer
- •Psychiatric symptoms that are explained by a physical illness with psychotropic effect or acute intoxication (e.g., cannabis use).
- •Diagnosis of a serious developmental disorder, e.g,. Asperger's syndrome
- •Currently receiving treatment with metylphenidate.
- •Rejects providing informed consent.
研究组 & 干预措施
Standard treatment + cognitive remediation
The cognitive remediation therapy targets neurocognition as well as social cognition.
干预措施: Cognitive remediation (Behavioral)
Standard treatment + cognitive remediation
The cognitive remediation therapy targets neurocognition as well as social cognition.
干预措施: Standard treatment (Behavioral)
Standard treatment
Patients allocated to the control condition are free to choose whatever standard treatment they are offered by the clinicians managing their treatment. Usually standard treatment consists of regular contact to health professionals in the in- and outpatient facilities in Copenhagen, Denmark, and encompass different kinds of supportive counselling
干预措施: Standard treatment (Behavioral)
结局指标
主要结局
Brief Assessment of Cognition in Schizophrenia (BACS)
时间窗: 6 and 12 months
BACS will be used to assess changes in cognition at the cessation of treatment at (6 months) and 12 months post baseline.
次要结局
- Brief Psychiatric Rating Scale Expanded Version (BPRS-E)(6 and 12 months)
- Scale for the Assessment of Negative Symptoms (SANS)(6 and 12 months)
- The Montgomery-Åsberg Depression Rating Scale (MADRS)(6 and 12 months)
- Personal and Social Performance Scale (PSP)(6 and 12 months)