A randomized control trial to study the efficacy of Tamil version of Metacognitive Training in patients with schizophrenia in Coimbatore
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 70
- 试验地点
- 1
- 主要终点
- •Score on Positive and Negative Symptom Scale (PANSS)
研究概览
简要总结
The study is a randomized control trial, a parallel group design with allocation ratio of 1:1, conducted at Krishna Nursing Home, Coimbatore.The two arms of the trial are: metacognitive training (experimental arm) and (active control arm) treatment as usual (TAU). The aim of the trial is to study the efficacy of Tamil version of metacognitive training.The primary outcome will be the score on Positive and Negative Symptom Scale measured two weeks after the intervention.The secondary outcomes will be score on Positive and Negative Symptom Scale measured 6 months and one year after the intervention termination, effect of metacognitive training on patient’s insight( as assessed by Beck’s Cognitive Insight Scale), relationship of positive symptoms and insight, effect of metacognitive training on patient’s belief (as assessed by Brown’s Assessment of Belief Scale), if metacognitive training improves patient’s metacognitive functioning ( as assessed by scores of metacognitive assessment scale) and to study the effect of metacognitive training on patient’s functioning (as assessed by World Health Organization Disability Assessment scale).The final outcome will be analyzed on intention to treat basis.The outcome assessors in the trial will masked to the allocation details. The metacognitive training, comprises of 10 modules consisting of PowerPoint slides. Each module addresses cognitive biases in a way that explains how they contribute to the formation of delusion followed by specific exercises to raise awareness about negative consequences of cognitive biases and concludes with learning aims and alternative thinking strategies to help them avoid cognitive biases that can lead to delusional beliefs. The therapy is intended as a supportive therapy along with the pharmacological treatment, aims to increase metacognitive awareness in patients.It is expected to reduce positive symptoms by making patients aware of their cognitive experiences facilitating adaptive responses and act prophylactically against relapse. Each session will last between 45 to 60 minutes.The participants will be block randomized and stratified according to participant’s age and years since diagnosis.
研究设计
- 研究类型
- Interventional
- 分配方式
- Stratified block randomization
- 盲法
- Outcome Assessor Blinded
入排标准
- 年龄范围
- 18.00 Year(s) 至 65.00 Year(s)（—）
- 性别
- All
入选标准
- •1.primary diagnosis of schizophrenia confirmed by Mini International Neuropsychiatric Interview (M.I.N.I), supplemented by DSM-V and clinical diagnosis.
- •2.participants should have at least 8 years of education 3.participants should have provided informed consent 4.participants should be able to read and speak Tamil language 5.all participant should be symptomatically stable at the time of enrollment, 6.Positive and Negative Syndrome Scale (PANSS) scores should be under 75, ratings of 3 (mild) or less on the PANSS psychosis items.
排除标准
- •1.any co-morbid psychiatric disorder, neurological disorders 2.history of substance or alcohol, formal thought disorder, aggressive behavior 3.IQ <70.
结局指标
主要结局
•Score on Positive and Negative Symptom Scale (PANSS)
时间窗: After 2 weeks, 6 months and 1 year of completion of intervention
•The experimentalintervention group is expected to show 40% reduction in the PANSS score whereas the control or the treatment as usual group is expected to show 10% reduction in the PANSS score.
时间窗: After 2 weeks, 6 months and 1 year of completion of intervention
Outcome Name:
时间窗: After 2 weeks, 6 months and 1 year of completion of intervention
Expected Outcome:
时间窗: After 2 weeks, 6 months and 1 year of completion of intervention
次要结局
- •To study the effect of metacognitive therapy on patient’s insight(•To study the relationship of positive symptom(as assessed by PANSS)and insight)