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CTRI Number  CTRI/2022/09/045791 [Registered on: 22/09/2022] Trial Registered Prospectively
Last Modified On: 28/04/2026
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Behavioral 
Study Design  Randomized, Parallel Group Trial 
Public Title of Study   Effectiveness of brief intervention on alcohol consumption among Chronic Liver Disease patients with alcohol use disorder. 
Scientific Title of Study   Effectiveness of brief intervention on alcohol consumption among Chronic Liver Disease patients with alcohol use disorder at Institute of Liver and Biliary Sciences, New Delhi. 
Trial Acronym   
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Chestha Arora 
Designation  M.Sc Nursing student 
Affiliation  College of Nursing, Institute of Liver and Biliary Sciences 
Address  ILBS, Vasant Kunj, New Delhi
Nehru nagar, Panipat
New Delhi
DELHI
110070
India 
Phone  7027144566  
Fax    
Email  chestha.213@gmail.com  
 
Details of Contact Person
Scientific Query
 
Name  Jithin Thomas Parel 
Designation  Lecturer 
Affiliation  College of Nursing, Institute of Liver and Biliary Sciences, deemed university under the UGC act 
Address  ILBS, Vasant Kunj, New Delhi

New Delhi
DELHI
110070
India 
Phone  8368621295  
Fax    
Email  jithuparel@gmail.com  
 
Details of Contact Person
Public Query
 
Name  Chestha Arora 
Designation  PG Student 
Affiliation  College of Nursing, Institute of Liver and Biliary Sciences, deemed university under the UGC act 
Address  ILBS, Vasant Kunj, New Delhi

New Delhi
DELHI
110070
India 
Phone  7027144566  
Fax    
Email  chestha.213@gmail.com  
 
Source of Monetary or Material Support  
Institute of Liver and Biliary Sciences, New Delhi 
 
Primary Sponsor  
Name  ILBS 
Address  Vasant Kunj 
Type of Sponsor  Research institution and hospital 
 
Details of Secondary Sponsor  
Name  Address 
NIL  NIL 
 
Countries of Recruitment     India  
Sites of Study  
No of Sites = 1  
Name of Principal Investigator  Name of Site  Site Address  Phone/Fax/Email 
Ms Chestha  Institute of liver and Biliary Sciences  Outpatient and inpatient department
South West
DELHI 
7027144566

Chestha.213@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Communication of the Decision of the College of Nursing Ethics Commitee  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: H||Substance Abuse Treatment,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Intervention  Brief Intervention  Brief intervention in this study is motivational interviewing and advice sessions as per World Health Organization Module that is planned according to their addiction levels. 
Comparator Agent  Routine Treatment  Routine Treatment including counseling from psychotherapist 
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  80.00 Year(s)
Gender  Male 
Details  1. Under criteria ICD 10
2. Scores more than 8 in AUDIT (moderate to severe risk)
3. Can understand English/ Hindi
4. Will visit the selected outpatient and admitted in inpatient department at ILBS. 
 
ExclusionCriteria 
Details  1. Patients with mental impairment, not able to provide informed consent
2. Those already undergoing alcohol reduction treatment
 
 
Method of Generating Random Sequence   Stratified block randomization 
Method of Concealment   Sequentially numbered, sealed, opaque envelopes 
Blinding/Masking   Open Label 
Primary Outcome  
Outcome  TimePoints 
Rate of alcohol consumption among Chronic Liver Disease patients with alcohol use disorder.  At day 7, 30, 60 and 90 
 
Secondary Outcome  
Outcome  TimePoints 
Association of alcohol consumption with selected clinical variables among Chronic Liver disease patients with alcohol use disorder.  At day 7, 30, 60 and 90 
Association of alcohol consumption with selected socio-demographic variables among Chronic Liver disease patients with alcohol use disorder.  At day 7, 30, 60 and 90 
 
Target Sample Size   Total Sample Size="110"
Sample Size from India="110" 
Final Enrollment numbers achieved (Total)= "Applicable only for Completed/Terminated trials"
Final Enrollment numbers achieved (India)="Applicable only for Completed/Terminated trials" 
Phase of Trial   N/A 
Date of First Enrollment (India)   01/10/2022 
Date of Study Completion (India) Applicable only for Completed/Terminated trials 
Date of First Enrollment (Global)  Date Missing 
Date of Study Completion (Global) Applicable only for Completed/Terminated trials 
Estimated Duration of Trial   Years="0"
Months="3"
Days="0" 
Recruitment Status of Trial (Global)   Not Yet Recruiting 
Recruitment Status of Trial (India)  Not Yet Recruiting 
Publication Details   none 
Individual Participant Data (IPD) Sharing Statement

Will individual participant data (IPD) be shared publicly (including data dictionaries)?  

Response - NO
Brief Summary
Modification(s)  

A randomized control trial is planned to be implemented on sample of 110 subjects who met inclusion criteria to see for effectiveness of brief intervention given by world Health Organization.

 

Goal of the study is to evaluate effectiveness of Brief intervention on alcohol consumption among Chronic liver disease patients with alcohol use disorder.

  

Background of Study

         Alcohol consumption, particularly heavy drinking, is an important risk factor for many health problems and represents a considerable contributor to the global burden of disease. As highlighted by the World Health Organization (WHO), public health problems caused by harmful use of alcohol represent a substantial health, social and economic burden worldwide. Harmful alcohol use seems a risk factor in more than 60 diseases and injuries resulting in approximately 2.5 million deaths per year worldwide. (Addolorato et al., 2013).

             

                 A study from Bangalore reported that one-fourth of adult men consumed alcohol. There are more than 200 million alcohol users estimated in India including 1.5 million deaths due to Alcoholic liver disease (Ray et al., 2014)

             

                Several meta-analyses have shown that screening using short questionnaires followed by brief intervention that is comprising simple advice or psychological counseling, significantly reduces alcohol consumption in primary care populations.(Kaner et al., 2013).

             

Findings from a research published in Addiction science and Clinical practice 2013, these findings have been mixed as to whether brief intervention (BI) is appropriate and effective for individuals with more severe alcohol use problems. Motivation to change drinking has been supported as a mechanism of behavior change for BI. The exploratory study examined aspects of motivation as mechanisms of clinical response to BI and alcohol problem severity as a moderator of treatment effects.(Meredith et al., 2021)

             

                  The study will focus on reducing alcohol use in patients who is suffering from alcohol use diseases with the use of brief intervention.


Objectives of the Study

          Primary objective:

1.      To evaluate effectiveness of brief intervention© on alcohol consumption among chronic liver disease patients with alcohol use disorder in Institute of Liver and Biliary Sciences, New Delhi.

           

          Secondary objective:

1.      To find association of alcohol consumption with selected clinical variables among Chronic Liver disease patients with alcohol use disorder.

2.      To find association of alcohol consumption with selected socio-demographic variables among Chronic Liver disease patients with alcohol use disorder.

 

Setting of the Study:

Outpatient and inpatient department of Institute of Liver and Biliary Sciences, New Delhi.

Population:  

CLD patients with Alcohol use disorder

Sampling Technique:

 Consecutive Sampling

 

 

Duration of intervention: Brief intervention© is short counseling session of about 10 minutes provided at Day 0, 7,30 and 60.

 

           The planned intervention is given in 2 phases:

 

          Phase 1. Rapport building.

               Points to be discussed in sessions are:

·       Scores on AUDIT

·       Indication of scores

·       History of alcoholism

·       Client’s feelings on his drinking pattern

·       Stage of behavioral change

 

          Phase 2. Brief Intervention© session

          Points to be discussed in this are:

•        Harmful Effects of Alcohol

•        Myths about de-addiction

•        Quality of life without alcohol

•        Perception of subject related to pros and cons of drinking

•        High risk situations and their prevention

•        Stick to plans

Screening is done with Alcohol, Smoking and Substance Involvement Screening Test (ASSIST) before randomization, after providing intervention, the subjects are retested with ASSIST at Day 7, 30, 60 and 90

 


 
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