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临床试验/CTRI/2024/07/071393
CTRI/2024/07/071393已完成不适用

Evaluation of anxiety symptoms in patients with alcohol use disorder and associated sociodemographic and clinical correlates: a tertiary hospital-based follow-up study

Kasturba medical college and Hospital1 个研究点 分布在 1 个国家目标入组 164 人开始时间: 2024年8月15日最近更新:

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
164
试验地点
1
主要终点
To evaluate for anxiety symptoms in patients diagnosed with alcohol use disorder.

研究概览

简要总结

This prospective longitudinal study aims to evaluate anxiety symptoms in patients with alcohol use disorder (AUD) and their impact on treatment outcomes. Conducted over a period of two years (July 2024 - July 2026) , the study will involve 164 patients aged 18-65 years, diagnosed with AUD as per DSM-5 criteria. The primary aim is to evaluate anxiety symptoms in patients with AUD and understanding its short term outcomes. Specific objectives include evaluating anxiety symptoms in AUD patients, comparing sociodemographic and clinical characteristics between patients with and without anxiety symptoms, and assessing the relationship between anxiety symptoms and drinking patterns over a three-month follow-up period. Inclusion criteria encompass patients of either gender, aged 18-65 years, outpatients and inpatients, who provide informed consent. Exclusion criteria include the presence of other substance use disorders (except nicotine dependence), comorbid depressive disorders or psychosis, and acute withdrawal (CIWA-Ar score >8). Justification for the study lies in the difficulty of diagnosing co-morbid anxiety disorders during initial assessment and detoxification phases, with existing literature showing inconsistent results regarding the outcomes of AUDs with co-morbid anxiety disorders. The study employs various tools including the semi-structured perfoma, Structured Clinical Interview for DSM-5 (SCID), State-Trait Anxiety Inventory (STAI-T5), Leeds Dependence Questionnaire (LDQ), Clinical Institute Withdrawal Assessment for Alcohol Scale (CIWA-Ar), Quick Drinking Screen (QDS), and Hospital Anxiety and Depression Scale (HADS) to collect data on sociodemographic details, alcohol use patterns, and anxiety levels. Although minimal risks are anticipated, primarily related to discomfort from interview questions, the study offers potential benefits by enhancing the understanding of anxiety prevalence in AUD patients, which could lead to improved management strategies for this population.

All the required permissions for using scales has been taken and translation of the scales to regional language has been done as per WHO translation guidelines.

研究设计

研究类型
Observational

入排标准

年龄范围
18.00 Year(s) 至 65.00 Year(s)(—)
性别
All

入选标准

  • Any patient diagnosed with alcohol use disorder coming to Kasturba Hospital Manipal and willing for follow up.

排除标准

  • Other substance use disorders except Nicotine dependence Patients with a comorbid diagnosis of depressive disorders and psychosis Patients in acute alcohol withdrawal.

结局指标

主要结局

To evaluate for anxiety symptoms in patients diagnosed with alcohol use disorder.

时间窗: At the time of recruitment

次要结局

  • To study the difference in socio demographic and clinical correlates in patients with alcohol(disorder with and without anxiety symptoms.)
  • To check if there is any relationship between presence of anxiety symptoms and drinking(pattern at a 3 month follow period.)

研究者

发起方
Kasturba medical college and Hospital
申办方类型
Private medical college
责任方
Principal Investigator
主要研究者

Neha P Shenoy

Kasturba Hospital, Manipal

研究点 (1)

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