A Randomized Control Trial to Study the Efficacy of Tamil Version of Integrated Psychological Therapy 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
- The scores on cognitive domains measured, which are:
研究概览
简要总结
The study is a randomized control trial, parallel group design with allocation ratio of 1:1, conducted at Krishna Nursing Home, Coimbatore.The two arms of the trial are: Integrated Psychological Therapy (experimental arm) and Treatment as usual (active control arm). The aim of the trial is to study the efficacy of the Tamil version of Integrated Psychological Therapy. Schizophrenia is a mental illness characterized by positive, negative, cognitive and mood symptoms. Studies have shown that cognitive variables are important predictors of patient’s functional outcome in spite of remission of positive and negative symptoms. Cognitive deficits which have a direct link with the functional outcome as proven by numerous studies continue to persist even as patients are clinically ’stable’.Cognition is studied as the primary outcome measure. The domains of cognition undertaken are speed of processing, attention/vigilance, working memory (non-verbal), working memory (verbal), verbal learning, visual learning, problem solving and social cognition. The proposed group intervention Integrated Psychological Therapy, focuses on rehabilitation of social cognitive and neurocognitive deficits among patients with schizophrenia.The therapy modules focus on developing the ability to regulate emotion and coping with emotional stress. The exercises are affectively neutral in the beginning and gradually advances to more complex and difficult tasks. The therapist is actively involved in the session, who is responsible for mediating and making the patient recognize appropriate and inappropriate show of emotion and discuss effective problem solving strategies.The project is unique in studying the treatment effectiveness of Tamil version of the therapy.It is expected that since literature suggests cognition as a strong predictor of functional outcome, remedying cognitive deficits would improve patient’s overall functioning and improve their employability
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
- •primary diagnosis of schizophrenia confirmed by The Mini International Neuropsychiatric Interview, (M.I.N. I) and supplemented by DSM-V 2)participants should have at least 8 years of education 3) able to read and speak Tamil language 4) all participants should be symptomatically stable at the time of enrollment 5) 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
- •Persons of 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
The scores on cognitive domains measured, which are:
时间窗: two weeks,6 months and one year after the intervention
Trail Making Test Part A, Wechsler’ subtests of Digit Span, Digit Symbol and Picture Arrangement, Rey–Osterrieth complex figure, Rey Auditory Verbal Learning Test, PGI Memory Scale
时间窗: two weeks,6 months and one year after the intervention
次要结局
- 1) Negative Symptoms Scores of the PANSS (Positive and Negative Syndrome Scale)(2) Social functioning (as assessed by World Health Organization Disability Assessment scale))