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临床试验/NCT06652802
NCT06652802尚未招募不适用

Effectiveness of Nurse-Conducted Brief Intervention (NCBI) Supplemented With Mobile-based Application for Monitoring and Relapse Prevention in Patients With Alcohol Use Disorders: A Randomized Controlled Trial

University of Pittsburgh0 个研究点目标入组 74 人开始时间: 2026年12月1日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
尚未招募
入组人数
74
主要终点
Effectiveness of Nurse-Conducted Brief Intervention (NCBI) supplemented with a Mobile Health Application in preventing relapse among patients with Alcohol Use Disorders (AUDs

研究概览

简要总结

The study is aimed to find out that combining Nurse-Conducted Brief Intervention (NCBI) with a Smart Mobile is better than Nurse-Conducted Brief Intervention (NCBI) only in preventing relapse among Alcohol Use Disorder patients. The high relapse rates among alcohol disorder patients may be benefitted by new technology using application for improved outcomes in managing and preventing alcohol addiction relapse.

详细描述

A Meta-analysis including 34 studies showed that Brief Intervention helped in reducing the amount of alcohol consumption after a study duration of 1 year in comparison with the control group. In India, there have been few studies on Brief Intervention. A comparison study of Brief intervention versus simple advice for Alcohol Use Disorder was conducted in North India in 2007, which showed a slight advantage for Brief intervention. But the results were not showing a significant outcome and it was concluded that booster sessions were required. A review of literature revealed that comprehensive recovery management systems using the capabilities of smart-phones to provide a variety of tools and services that can be tailored to individuals, including in-the-moment assessments and access to peer discussion groups have the strongest theoretical base and have yielded the strongest and longest-lasting effects for management of alcohol use disorders. [10]. A study review revealed that smartphone application has the potential to monitor alcohol use and craving in the natural environment and deliver tailored treatment to users when they need it most. A study revealed that smartphone-delivered coping strategies for alcohol cravings are effective in reducing craving cued drinking and that craving cues related to drinking environments and drinking times of day represent fruitful areas of intervention focus.

JUSTIFICATION / NEED FOR THE STUDY The present studies suggest that a substantial proportion of patients with alcohol use disorders relapse to alcohol during the course of treatment. Efforts are required to delay and avoid such relapse and maintain abstinence by effective treatment approaches. A major barrier to care is the lack of adequately skilled human resources to deliver contextually appropriate treatments. Nurse-conducted Brief Intervention supplemented with mobile application-based can be a beneficial approach to prevent relapse and support patients in their journey to overcome alcohol addiction. It also promotes a more continuous and connected recovery process by enabling regular communication and data sharing between the user and their counsellor.

Proposed Methodology: Only males will be included in the study.

  • Including women in this study would necessitate a gender-specific analysis [5], which could complicate the primary objective of evaluating the combined intervention of Nurse-Conducted Brief Intervention (NCBI) and a mobile based application.
  • To maintain the internal validity of this study and to ensure a clear, focused evaluation of the intervention, the investigators have chosen to initially focus on male participants.
  • The non-availability of female patients or a smaller number of female patients according to hospital admission records diagnosed with alcohol dependence admitted to the hospital ward due to stigma will also affect the data collection process.
  • Future studies will aim to address the effectiveness of these interventions specifically for women, considering their unique needs and responses to treatment.

SAMPLE SIZE and the BASIS for the same:

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Treatment
盲法
Single (Outcomes Assessor)

盲法说明

The study is designed as single-blind, meaning the outcome assessors and the data analysts will be blinded to the group allocations to reduce bias in the evaluation of the outcomes

入排标准

年龄范围
18 Years 至 59 Years(Adult)
性别
Male
接受健康志愿者

入选标准

  • Male patients.
  • Aged between 18 and 59 years.
  • Diagnosis of alcohol dependence use disorder based on ICD-10 criteria.
  • Patients with an Android smartphone and the ability to use mobile application.

排除标准

  • Female patients
  • Comorbid other substance abuse, except tobacco.
  • Comorbid major mental illness /physical illness.

研究组 & 干预措施

Nurse-Conducted Brief Intervention (NCBI). supplemented with mobile based application

Experimental

Experimental group participants receive Nurse-Conducted Brief Intervention (NCBI). supplemented with mobile based application. Due to the availability of Nurse Conducted Brief intervention (NCBI) service in Gastroenterology department by trained nurse it was done in the gastroentrology department.

干预措施: Nurse-Conducted Brief Intervention (NCBI). supplemented with mobile based application. (Behavioral)

Nurse-Conducted Brief Intervention (NCBI)

Active Comparator

Control group participants receive only Nurse-Conducted Brief Intervention (NCBI).

干预措施: Nurse-Conducted Brief Intervention (NCBI) (Behavioral)

结局指标

主要结局

Effectiveness of Nurse-Conducted Brief Intervention (NCBI) supplemented with a Mobile Health Application in preventing relapse among patients with Alcohol Use Disorders (AUDs

时间窗: Three months period

The primary endpoint of the study is the effectiveness of Nurse-Conducted Brief Intervention (NCBI) supplemented with a Mobile Health Application in preventing relapse among patients with Alcohol Use Disorders (AUDs) over a three-month period. • The primary outcome measure will be the difference in relapse rates between the group receiving NCBI with the mobile application and the group receiving only NCBI.

次要结局

  • Provide insight into the effectiveness and impact of the interventions: Sociodemographic(Baseline)
  • Provide insight into the effectiveness and impact of the interventions: Severity of AUD(Baseline)
  • Provide insight into the effectiveness and impact of the interventions:Lapse evaluation(Baseline)
  • Provide insight into the effectiveness and impact of the interventions: comparison with sociodemographic factors(Baseline)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Vishwajit Nimgaonkar, MD PhD

Professor of Psychiatry and Human Genetics

University of Pittsburgh

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