Utility of Mobile Messages in Preventing Relapse in Patients of Alcohol Dependence: A Pilot Randomized Controlled Study
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
Dr Avika Gupta
All India Institute of Medical Sciences, Raipur
