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临床试验/CTRI/2022/04/042305
CTRI/2022/04/042305尚未招募不适用

Feasibility of social cognition and interaction training in persons with schizophrenia adapted to an Indian context

NIMHANS1 个研究点 分布在 1 个国家目标入组 30 人开始时间: 2022年2月5日最近更新:

试验速览

阶段
不适用
状态
尚未招募
发起方
NIMHANS
入组人数
30
试验地点
1
主要终点
Primary outcome is Social Cognition

研究概览

简要总结

Aim and Objectives: The primary aim of this study is to adapt Social Cognition and Interaction Training (SCIT) to an Indian Context and evaluate its feasibility in patients with Schizophrenia.  Following are the  objectives as per the phase in which the study will take place:

 Phase I:

To adapt SCIT to an Indian context.

Phase II:

To evaluate the feasibility of a contextually adapted intervention for social cognition in patients with schizophrenia.

(1)   To examine the rate of recruitment to the study among eligible patients with schizophrenia.

(2)   To examine the attrition rate among eligible patients consenting to receive the intervention.

(3)   To examine the acceptability of the intervention among eligible patients receiving the intervention.

(4)   To conduct limited efficacy testing of the adapted intervention on outcome measures of social cognition, symptoms of schizophrenia, neurocognition,   recovery, quality of life, and disability.

 Background and Rationale: Social cognition refers to mental operations that underlie social interactions, including perceiving, interpreting, and generating responses to the intentions, dispositions, and behaviors of others. Social cognition is considered to have four primary domains: emotional and social perception, theory of mind (ToM), and attributional style. Social Cognition has been identified as a deficit consistently across various stages and episodes in persons with Schizophrenia. In the Indian context, though social cognition as a domain has been researched along with the adaptation of tools to measure social cognition, published research on comprehensive interventions for social cognition as well as their availability and implementation is limited. Hence, it was decided to adapt called “Social Cognition and Interaction Training (SCIT)†in an Indian context, which has efficacy in various settings and has been adapted in various countries. This intervention widely covers the domains of social cognition and approaches intervention purely from a social cognitive perspective while taking a practical standpoint. It is thus important to have a contextualized intervention that is also feasible to use.

Method: This study will follow an open-label design with a single-arm experimental research design with baseline, post-module (aspects of acceptability), and post-intervention assessments. This study will be conducted in two main phases wherein the first phase would involve adaptation (in terms of the process, duration, frequency, mode of delivery, content, language, images, video, audio files, etc.) of the intervention in consultation with the authors (with expert validation), and a pilot study for patients with schizophrenia early in their course.

The second phase of the study aims to evaluate the feasibility of the intervention in domains of acceptability, recruitment rate, attrition, and limited-efficacy testing (n=30) for patients with schizophrenia early in their course, with > 10 years duration of illness, between 18-50 years of age with minimum education till class 7. Some of the outcome measures associated with limited-efficacy testing include symptomatology, social cognition, neuro-cognition, recovery, quality of life, and disability. Towards the end, attempts will be made to manualize the adapted intervention and make it widely accessible for use.

Analysis: Appropriate statistical analysis techniques involving descriptive and inferential statistics will be used, along with thematic analysis for the qualitative aspects for interpretation.

研究设计

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

入排标准

年龄范围
18.00 Year(s) 至 50.00 Year(s)(—)
性别
All

入选标准

  • Persons diagnosed with Schizophrenia 2) Duration of illness <10 years 3) CGI score<3 4) Change of medications by less than 25% of their dose in the past 8 weeks 5) Minimum education up to class
  • 18-50 years of age 7) Working knowledge of English or Hindi.

排除标准

  • Co-morbid neurological conditions 2) History of head injury 3) Currentsubstancedependence,except nicotine 4) Clinical evidence of intellectual disability 5) Current symptoms of severe depression 6) Having undergone electroconvulsive therapy in the preceding six months 7) Having received social skills/cognition training of at least ten sessions in the past one year.

结局指标

主要结局

Primary outcome is Social Cognition

时间窗: Baseline and post-intervention.

次要结局

  • Symptomatology, neuro-cognition, recovery, quality of life and disability.(Other aspects of feasibility i.e. acceptability, attrition rate and rate of recruitment.)

研究者

发起方
NIMHANS
申办方类型
Research institution and hospital

研究点 (1)

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