The Effectiveness of The Meta-cognitive Training Among Chronic Schizophrenia Patients Treated Within Community Support Groups in Poland.
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 50
- 试验地点
- 2
- 主要终点
- Psychotic Symptom Rating Scale (The PSYRATS)
研究概览
简要总结
The aim of the study is to compare the effectiveness of the meta-cognitive training (MCT) for schizophrenia against treatment as usual (TAU) among patients who attends community support groups. 4 weeks of MCT will be administered for patients two times per week. MCT consists of well structured cognitive behavioral therapy interventions. MCT will be administered according authors recommendations. All participants will be assessed at baseline (T0) and up to one week after the MCT intervention (T1, 4-5 week of the study).
详细描述
50 patients with established schizophrenia diagnosis will be included and randomized into two conditions: MCT (n= 25) and TAU (n=25). Exclusion criteria are: neurological diseases, substance dependence (alcohol and drugs).
A broad outcome measures will be provided including symptoms severity, cognitive biases, neurocognition, insight and social functioning. Changes in variable after the intervention will be compared between two condition.
Only patients with established schizophrenia with no neurological diseases will be included.
All patients will be assessed at two time points: T0 - at baseline, up to one week before the intervention starts and T1 up to one week after the intervention is finished. T1 assessment will be at 4-5 weeks after the study begun.
Measures
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 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •schizophrenia diagnosis accotding to the ICD-10 criteria
- •attending local community support groups for psychitatric patients
排除标准
- •neurological diseases
- •substance abuse
- •severe psychotic symptoms
研究组 & 干预措施
TAU
Treatment as Usual (TAU) vs meta-cogntive training (MCT) condition will be contrasted. In the TAU patients attend regular day programm that includes psychoeducation, social training, vocational rehabilitation, psychotherapy. The MCT condition is an active condition that includes structuralized therapy modules twice a week for four weeks (eight modules in total). There will be no additional differences in the interventions between two groups. Participants will be randomized from patients from the same population into two conditions.
结局指标
主要结局
Psychotic Symptom Rating Scale (The PSYRATS)
时间窗: week 0
The severity of delusions and hallucinations were assessed at the baseline and after the intervention with the semi-structured Psychotic Symptom Rating Scale. The PSYRATS comprises hallucination and delusions subscale, each design to assess psychological aspects of the symptoms on a five point scale from 0 to 4.
[change] Psychotic Symptom Rating Scale (The PSYRATS)
时间窗: week 4-5
The severity of delusions and hallucinations were assessed at the baseline and after the intervention with the semi-structured Psychotic Symptom Rating Scale. The PSYRATS comprises hallucination and delusions subscale, each design to assess psychological aspects of the symptoms on a five point scale from 0 to 4.
次要结局
- Cognitive Biases Questionnairre for Psychosis (CBQp)(week 0)
- [Change] Cognitive Biases Questionnairre for Psychosis (CBQp)(week 4-5)
研究者
Łukasz Gawęda
PhD
Medical University of Warsaw