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临床试验/CTRI/2024/07/070702
CTRI/2024/07/070702
尚未招募
不适用

Construction and validation of a tool for measuring visual abstract reasoning in patients with alcohol dependence (VisAR-AD)

Sai Chandana Mukkamala1 个研究点 分布在 1 个国家目标入组 168 人开始时间: 2024年8月1日最近更新:

概览

阶段
不适用
状态
尚未招募
发起方
Sai Chandana Mukkamala
入组人数
168
试验地点
1
主要终点
Score on visual abstract reasoning task

概览

简要总结

The review of literature highlights the impact of alcohol misuse on cognitive functions, particularly abstract reasoning, emphasizing the need for specialized assessments tailored to individuals with alcohol dependence. Existing neuropsychological evaluations often lack sensitivity in this population, underscoring the necessity of developing dedicated tools. Studies indicate significant differences in abstract reasoning abilities between alcohol-dependent individuals and healthy controls, reinforcing the importance of accurate assessment methods tailored to the target population.

The study aims to develop and validate a tool for assessing visual abstract reasoning among patients diagnosed with alcohol dependence in India, addressing the lack of culturally relevant assessment tools for this population. This tool’s construction and validation involve several steps, including the selection of culturally appropriate stimuli and validation among patients with alcohol dependence. The absence of such a tool hampers the precise evaluation of cognitive and psychological impairments linked to alcohol use and impedes the formulation of personalized treatment strategies.

Inclusion criteria for cases require a diagnosis of alcohol dependence according to ICD 11 criteria, while healthy controls must fall within specific age ranges and exhibit no signs of psychiatric illness. Exclusion criteria aim to eliminate factors such as other psychiatric diagnoses or major medical illnesses. The statistical methods employed include descriptive analysis, item analysis, and validation techniques to establish the tool’s reliability and validity. Tools utilized in the study encompass various assessments, including the General Health Questionnaire-5, Clinical Institute Withdrawal Scale, Severity of Alcohol Dependence Questionnaire, Verbal Similarities Test of Abstract Reasoning, and Digit Repetition Test.

The detailed procedure involves multiple phases, including item construction, expert validation, and pilot testing, culminating in the validation phase with data collection from cases and controls. Potential risks are minimal, mainly involving discomfort in answering sensitive questions, while benefits include the construction of a novel tool with implications for interventions. Ethical considerations prioritize informed consent, participant rights, confidentiality, and anonymity.

研究设计

研究类型
Observational

入排标准

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

入选标准

  • Diagnosed with the ICD 11 (DCR) criteria for Alcohol dependence
  • Males between the age group 18-
  • Ability to speak and understand either English or Kannada languages.
  • A score of lesser than 10 on Clinical Institute Withdrawal Scale (CIWA).
  • Healthy Controls
  • Males between the age group of 18-
  • Individuals scoring below 2 on the GHQ-5.

排除标准

  • Any other Axis 1 psychiatric diagnoses except nicotine dependence.
  • Any personal history of neurological, major medical illness and psychiatric illness(Schizophrenia, Mood disorder, Anxiety disorder and OCD).
  • Healthy Controls
  • Any personal history of neurological, major medical illness and psychiatric illness (Schizophrenia, Substance use disorder, Mood disorder, Anxiety disorder and OCD).

结局指标

主要结局

Score on visual abstract reasoning task

时间窗: Baseline & 12 weeks

Score on verbal abstarct reasoning task

时间窗: Baseline & 12 weeks

次要结局

未报告次要终点

研究者

发起方
Sai Chandana Mukkamala
申办方类型
Other [Self ]
责任方
Principal Investigator
主要研究者

Sai Chandana Mukkamala

Manipal college of health professions

研究点 (1)

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