Interventional study to evaluate effectiveness of brief motivational interviewing on motivation and consumption of alcohol in patients of alcohol use disorder in tertiary care hospital
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- 入组人数
- 80
- 试验地点
- 1
- 主要终点
- Change in Alcohol Consumption - Change in scores of Alcohol Use Disorder Identification Test scale.
研究概览
简要总结
This study aims to evaluate the effectiveness of Brief Motivational Interviewing on motivation and alcohol consumption in patients with Alcohol Use Disorder.
The primary hypothesis is that there will be no significant difference in the change in alcohol consumption and motivation between The Standard Of Care group and The Brief Motivational Interviewing combined with Standard Of Care group.
Motivational Interviewing is a person-centered, guiding method of communication and counseling designed to elicit and strengthen motivation for change.
The study is designed as a randomized controlled trial with two groups.
Participants diagnosed with Alcohol Use Disorder will be randomly assigned to either the Standard of Care group or the Brief Motivational Interviewing combined with Standard of Care group.
The total sample size is 80 participants, with 40 individuals in each group.
The intervention will be delivered using a structured and validated module in English, Marathi and Hindi language based on the Motivational Enhancement Therapy manual, which is part of the National Institute on Alcohol Abuse and Alcoholism’s Project MATCH.
The intervention consists of two sessions: the first session will last for 30 to 45 minutes, and the second session for 10 to 15 minutes. The co-investigator delivering the intervention has been trained and certified in motivational interviewing techniques.
Outcomes will be measured in both groups at baseline and 12 weeks after the intervention. Motivation will be assessed using the Readiness to Change Questionnaire RCQ, and alcohol consumption will be evaluated using the Alcohol Use Disorder Identification Test AUDIT.
研究设计
- 研究类型
- Interventional
- 分配方式
- Computer generated randomization
- 盲法
- Participant Blinded
入排标准
- 年龄范围
- 21.00 Year(s) 至 60.00 Year(s)（—）
- 性别
- All
入选标准
- •1.Patients who fulfill the DSM 5 TR criteria for alcohol use disorder
- •Age group of 21- 60 years.
排除标准
- •1.Patients with other psychiatric disorders.
- •Other major medical comorbidities involving serious liver pathology.
- •E.g. hepatic carcinoma, advanced alcoholic liver cirrhosis, etc.
- •who is not in a state to undergo interventional therapy.
- •Other substance use disorders except tobacco.
- •Patient not able to read and write Marathi or Hindi or English language.
结局指标
主要结局
Change in Alcohol Consumption - Change in scores of Alcohol Use Disorder Identification Test scale.
时间窗: 3 months
Change in Motivation - change in Readiness to Change Questionnaire Total Score and subscale (stage-wise) scores (Precontemplation, Contemplation, Action) between baseline and end of intervention
时间窗: 3 months
次要结局
未报告次要终点