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临床试验/CTRI/2025/08/093551
CTRI/2025/08/093551尚未招募不适用

Utility of Mobile Messages in Preventing Relapse in Patients of Alcohol Dependence: A Pilot Randomized Controlled Study

All India Institute of Medical Sciences, Raipur1 个研究点 分布在 1 个国家目标入组 100 人开始时间: 2025年9月5日最近更新:

试验速览

阶段
不适用
状态
尚未招募
入组人数
100
试验地点
1
主要终点
To compare time to relapse in patients with alcohol dependence receiving mobile messages and treatment-as-usual with those receiving only treatment-as-usual

研究概览

简要总结

STUDY TITLE: Utility of Mobile Messages in Preventing Relapse in Patients of Alcohol Dependence: A Pilot Randomized Controlled Study

BACKGROUND:

As per NMHS, 2015-16, the prevalence of Alcohol Use Disorder (AUD) is 4.7%, while the treatment gap for the same is 86.3%. Relapse rates in patients of AUD can vary from 3-90%. Studies have shown that SMS reminders can work as a simple yet cost-effective tool to deliver healthcare services in low resource settings.

JUSTIFICATION OF THE STUDY

Given the significant treatment gap in alcohol use disorder and limited healthcare resources, it is crucial to leverage available tools, especially technology, in creative, cost-effective, and impactful ways, particularly in low- to middle-income settings.

Research shows that SMS based interventions could improve treatment outcomes in patients with AUD. Few studies in India have explored mobile interventions, mostly targeting hazardous alcohol use. Research is needed to assess the effectiveness of SMS-based support in alcohol dependence

OBJECTIVE

To compare time to relapse in patients with alcohol dependence receiving mobile messages and treatment-as-usual with those receiving only treatment-as-usual

METHODOLOGY

After recruitment, patients will be randomly allocated to one of the two groups, the intervention or the control group. Randomization will be done in blocks of four. Patients in the intervention group will receive 2 messages per week, whereas patients in the control group will receive one message every 15 days. The content of the messages sent to the two groups will be different. Patients in both the treatment arms will receive the treatment as usual as well. Patients will be assessed at 1, 2 and 3 months after recruitment to the study.

研究设计

研究类型
Interventional
分配方式
Randomized
盲法
Investigator Blinded

入排标准

年龄范围
18.00 Year(s) 至 80.00 Year(s)(—)
性别
Male

入选标准

  • Diagnosis of Alcohol Dependence (6C40.2) as per ICD-11 Has used alcohol at least once in the last one month Has not used alcohol for at least last seven days CIWA-Ar score less than 10 Possesses a personal, functional mobile phone and familiar with the process of reading a text message Able to read Hindi Provides written informed consent for participation in the study.

排除标准

  • Patients dependent on any other substance except nicotine and caffeine 2) Presence of any other psychiatric disorder, organic mental disorder, or mental retardation 3) Patients with unstable medical conditions including delirium, seizure, or severe alcohol withdrawal requiring priority medical management.
  • Patient who has received in-patient treatment for alcohol dependence in the last three months.

结局指标

主要结局

To compare time to relapse in patients with alcohol dependence receiving mobile messages and treatment-as-usual with those receiving only treatment-as-usual

时间窗: Participants will be followed up at 1,2 and 3 months after recruitment. The endpoint of the study shall be an event of relapse or completion of three months’ time since enrolment in the study.

次要结局

  • 1) Time to first drink in the two groups(2) Total days of abstinence in two groups)

研究者

申办方类型
Government medical college
责任方
Principal Investigator
主要研究者

Dr Avika Gupta

All India Institute of Medical Sciences, Raipur

研究点 (1)

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