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临床试验/CTRI/2017/04/008351
CTRI/2017/04/008351已完成不适用

“Modification and Demonstration of Efficacy of an Existing Module for Affect Recognition Training in Schizophreniaâ€

Indian Council of Social Science Research1 个研究点 分布在 1 个国家目标入组 40 人开始时间: 2014年9月23日最近更新:

试验速览

阶段
不适用
状态
已完成
入组人数
40
试验地点
1
主要终点
Primary outcome is improvement in facial emotion recognition.

研究概览

简要总结

Schizophrenia is one of the chronic mental illness and one among the global burden of diseases. It effect not only individual it also effects family member and whole society. schizophrenia patients basically faces deficits in their self care, interpersonal relationships, communication and in their occupation and in family life. Research studies have already established that schizophrenia patients also have cognitive disabilities. In recent time it also found that schizophrenia patients have social cognition deficits too. It means they have difficulty in understanding others emotions and social situations and attributional bias and deficits in their theory of mind. Western countries have already developed psychological inteventional programs to reduce this deficits and improve their social functioning. However in India we do have assessment tools for identifying these deficits but we do not have intervention program to reduce this deficits. Hence this study would like to fill this gap in research field as well as would like to help our patients population in reducing their deficits in social cognition. Researcher hypothesis is this intervention program will help in reducing facial emotion recognition deficits in schizophrenia patients.

Results: In this study person with schizophrenia (study group) found statistically significant improvement in their ability in identifying facial emotions than control group patients. However there was no significant improvement noticed in patients socio-occupational functioning after the intervention program. It may be also possible that training of affect recognition influence higher order social functioning which is not assessed by socio-occupational functioning scale (SOFS). Hence it require further studies on these area with more number of sample size and adequate socio occupational functioning assessment scale which can assess  the improvement occurred due to the emotion recognition training program.

研究设计

研究类型
Interventional
分配方式
Not Applicable
盲法
Open Label

入排标准

年龄范围
18.00 Year(s) 至 55.00 Year(s)(—)
性别
All

入选标准

  • Persons who give consent for the study
  • Educated at least up to 7th standard and should be able to read Kannada.
  • Persons who meet the criteria of schizophrenia according to ICD
  • PANSS score of ≤ 70
  • Clinical Global impression Severity(CGI-S) ≤3
  • Hindi Mental State Examination score >24
  • On stable dose of antipsychotic medication for last 4 weeks.

排除标准

  • Patients with comorbid neurological disorder such as seizure disorder, stroke, head trauma or mental retardation.
  • Patients with comorbid depression or OCD on clinical interview.
  • Patients meeting criteria for substance dependence other than nicotine in the last 6 weeks.
  • During the intervention if patient shows signs of relapse, PANSS will be repeated and if he/she scores more than 70 in PANSS, he/she will be dropped from the study.

结局指标

主要结局

Primary outcome is improvement in facial emotion recognition.

时间窗: Baseline to post assessment (one and half month) and the conducting two to three months of followup after the post assessment

次要结局

  • secondary outcome is improvement in attention and working memory(Baseline to post assessment (one and half month) and the conducting two to three months of followup after the post assessment)

研究者

申办方类型
Government funding agency

研究点 (1)

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