| CTRI Number |
CTRI/2025/06/088859 [Registered on: 13/06/2025] Trial Registered Prospectively |
| Last Modified On: |
10/06/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Behavioral |
| Study Design |
Randomized, Parallel Group, Active Controlled Trial |
|
Public Title of Study
|
Interventional study to evaluate effectiveness of Brief
Motivational Interviewing on motivation and consumption of
alcohol in patients of Alcohol use disorder |
|
Scientific Title of Study
|
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 |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Alka Subramanyam |
| Designation |
Additional Professor and Guide Department of Psychiatry |
| Affiliation |
Topiwala National Medical College and B.Y.L Nair Hospital Mumbai |
| Address |
OPD 13,
Department of Psychiatry
first floor OPD Building
T.N.M.C and B.Y.L Nair Hospital,
Anandrao Nair marg, Mumbai
Mumbai
MAHARASHTRA
400008
India |
| Phone |
9820143245 |
| Fax |
|
| Email |
alka.subramanyam@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Rohit Rameshwar Ganorkar |
| Designation |
Junior Resident in Department of Psychiatry |
| Affiliation |
Topiwala National Medical College and B.Y.L Nair Hospital Mumbai |
| Address |
OPD 13 , Department of Psychiatry, first floor OPD Building
Topiwala National Medical College and B.Y.L Nair Hospital, Anandrao Nair Marg, Mumbai
Mumbai
MAHARASHTRA
400008
India |
| Phone |
9011758584 |
| Fax |
|
| Email |
rohitganorkar@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Rohit Rameshwar Ganorkar |
| Designation |
Junior Resident in Department of Psychiatry |
| Affiliation |
Topiwala National Medical College and B.Y.L Nair Hospital Mumbai |
| Address |
OPD 13, Department of Psychiatry, OPD Building, 1st Floor, Topiwala National Medical College and B.Y.L Nair Hospital, Anandrao Nair Marg, Mumbai
Mumbai
MAHARASHTRA
400008
India |
| Phone |
9011758584 |
| Fax |
|
| Email |
rohitganorkar@gmail.com |
|
|
Source of Monetary or Material Support
|
|
|
Primary Sponsor
|
| Name |
Dr. Alka Subramanyam |
| Address |
Department of Psychiatry
T.N.M.C and B.Y.L Nair Hospital Mumbai 400008 |
| Type of Sponsor |
Other [SELF] |
|
|
Details of Secondary Sponsor
|
| Name |
Address |
| Dr Rohit Ganorkar |
Department of Psychiatry
T.N.M.C and B.Y.L Nair Hospital Mumbai 400008 |
|
|
Countries of Recruitment
|
India |
|
Sites of Study
|
| No of Sites = 1 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Dr Alka Subramanyam |
T. N. Medical college and BYL Nair hospital |
OPD 13, OPD Building, first floor, Topiwala National Medical College and B.Y.L Nair Hospital, Anandrao Nair marg Mumbai
Mumbai
MAHARASHTRA |
9820143245
alka.subramanyam@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Ethics Committee for academic research projects ( ECARP) T. N Medical college and BYL Nair hospital |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: F109||Alcohol use, unspecified, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Brief Motivational interviewing |
Intervention will be done by using designed and validated module for intervention, which is based on
Motivational Enhancement Therapy Manual: A Clinical Research Guide for therapists treating
individuals with alcohol abuse and dependence, national institute on alcohol abuse and
alcoholism project MATCH.
Motivational interviewing is a person-centered, guiding method of communication and
counseling to elicit and strengthen motivation for change. Principles of motivational interviewing are expressing empathy, developing discrepancies, rolling with resistance, and supporting self-efficacy.
The co-investigator of the study will conduct brief motivational interviewing as part of the
intervention.
To ensure the effectiveness of the intervention, the co-investigator has completed the
Primer on Motivational Interviewing certification course from the National Institute of
Mental Health and Neurosciences (NIMHANS), equipping his with the necessary skills
and expertise to deliver high-quality motivational interviewing.
The duration of Session 1 is 30-45 minutes, and 2 weeks later, Session 2 is 10-15 minutes.
This intervention is along with Standard of care, which will be given in psychiatry department.
|
| Comparator Agent |
Standard of care |
Psychiatry department follows a comprehensive approach to manage Alcohol Use
Disorder. This includes thorough assessment, withdrawal management using benzodiazepines, and pharmacotherapy with anticraving medication for relapse prevention.
Providing feedback with brief advice on cue management strategies such as avoidance, substitution, and distraction. Aftercare focuses on rehabilitation, follow-up programs, and support group participation, all delivered by a multidisciplinary team to ensure patient-centered and holistic care.
Due to limitations in time, workforce, and resources, comprehensive psychosocial interventions such as cognitive behavioral therapy (CBT), motivational enhancement therapy (MET), and family counseling are infrequently implemented. |
|
|
Inclusion Criteria
|
| Age From |
21.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
1.Patients who fulfill the DSM 5 TR criteria for alcohol use disorder
2. Age group of 21- 60 years |
|
| ExclusionCriteria |
| Details |
1.Patients with other psychiatric disorders.
2. 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.
3. Other substance use disorders except tobacco.
4. Patient not able to read and write Marathi or Hindi or English language |
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
An Open list of random numbers |
|
Blinding/Masking
|
Participant Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
Change in Alcohol Consumption - Change in scores of Alcohol Use Disorder Identification Test scale.
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
|
3 months |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| NIL |
NIL |
|
|
Target Sample Size
|
Total Sample Size="80"
Sample Size from India="80"
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)
|
25/06/2025 |
| 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="1"
Months="0"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Not Yet Recruiting |
|
Publication Details
|
N/A |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
|
Brief Summary
|
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. |