The Effectiveness and Efficacy of the Combination of the Integrated Psychological Therapy and Metacognitive Training in Schizophrenia and Treatment Resistant Schizophrenia. This is a Non-randomized Trial. The Therapy Lasts 60 Sessions.
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 发起方
- 入组人数
- 35
- 试验地点
- 2
- 主要终点
- Symptoms, PANSS Greek Version
研究概览
简要总结
The combination of the Integrated Psychological Therapy and Metacognitive Training in individuals with schizophrenia and treatment resistant schizophrenia.
Is it effective and efficacious?
详细描述
Individuals with schizophrenia and treatment resistant schizophrenia will participate on a group cognitive behavioral therapy and rehabilitation, in which Integrated Psychological Therapy and Metacognitive Training are going to be implemented. The therapy will last 60 biweekly sessions. This is a non randomized trial.
Speed of processing, working memory, verbal memory, visual memory, reasoning and problem solving, social cognition, symptoms, functional outcome and recovery will be evaluated before, after therapy and in a 6 months follow up.
MCCB, Social Perception Scale, the Greek Test for verbal memory, PANSS, WHO DAS 2. 0 (Greek), PSYRAT and the Recovery Assessment Scale will be used ih this study.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- Single (Outcomes Assessor)
入排标准
- 年龄范围
- 19 Years 至 60 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Diagnosis of schizophrenia
- •No relapse and hospitalization
- •Ambulant psychiatric treatment
排除标准
- •Other psychotic disorders
- •Relapse and hospitalization
- •Substance abuse
结局指标
主要结局
Symptoms, PANSS Greek Version
时间窗: Baseline T1 (preintervention)-follow-up T3 (after 6 months, up to 55 weeks)
(PANSS) Greek Version Positive symptoms (minimum 8 maximum 49) low scores better outcomes Negative symptoms: (minimum 8 maximum 49) low scores better outcomes General Psychopathology: (minimum 17 maximum 112) low scores better outcomes Total: Sum of positive, negative and general symptoms (minimum 31, maximum 210), low scores better outcomes The total score is used in the statistical analysis (PSYRAT) Auditory hallucinations (minimum 0 maximum 44) low scores better Delusion (minimum 0 maximum 24) low scores better Data is analyzed with SPSS 13
Functional Outcome
时间窗: Baseline T1 (preintervention)-follow-up T3 (after 6 months, up to 55 weeks)
WHO DAS 2.0 WHODAS total: (functional outcome) (minimum 0-maximum 100) low scores better outcomes Data are analyzed with SPSS 13
Recovery
时间窗: Baseline T1 (preintervention)-follow-up T3 (after 6 months, up to 55 weeks)
RAS-DS scale Total score (sum of the scores) (0-152) high scores are better outcomes Data is analyzed through SPSS 13
Cognitive Functions: Matrics Consensus Cognitive Battery (MCCB), Greek Verbal Test
时间窗: Baseline T1 (preintervention)-follow-up T3 (after 6 months, up to 55 weeks)
Greek verbal memory test: (verbal memory semantic condition (average) (minimum 0-maximum 40) (high scores better outcomes) MCCB: (Neuropsychological Assessment Battery) (NAB) (reasoning and problem solving): (minimum 0 maximum 26) (high scores better outcomes) Data is analyzed through SPS 13.
次要结局
- Intelligent Quotient(Baseline T1 (preintervention))