| CTRI Number |
CTRI/2025/08/093551 [Registered on: 25/08/2025] Trial Registered Prospectively |
| Last Modified On: |
25/08/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Other (Specify) [mobile SMS based intervention)] |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
Use of Mobile Text Messages to Prevent Return to Drinking in Patients of Alcohol Dependence: A Pilot Randomized Controlled Trial |
|
Scientific Title of Study
|
Utility of Mobile Messages in Preventing Relapse in Patients of Alcohol Dependence: A Pilot Randomized Controlled Study |
| 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 Avika Gupta |
| Designation |
Post Graduate Junior Resident |
| Affiliation |
All India Institute of Medical Sciences, Raipur |
| Address |
Department of Psychiatry, First Floor, C-Block, All India Institute of Medical Sciences, Tatibandh, Raipur
Raipur
CHHATTISGARH
492099
India |
| Phone |
9711120674 |
| Fax |
|
| Email |
avikagupta98@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Aditya Somani |
| Designation |
Associate Professor |
| Affiliation |
All India Institute of Medical Sciences, Raipur |
| Address |
Department of Psychiatry, First Floor, C-Block, All India Institute of Medical Sciences, Tatibandh, Raipur
Raipur
CHHATTISGARH
492099
India |
| Phone |
9592916918 |
| Fax |
|
| Email |
dr.adityasomani@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Aditya Somani |
| Designation |
Associate Professor |
| Affiliation |
All India Institute of Medical Sciences, Raipur |
| Address |
Department of Psychiatry, First Floor, C-Block, All India Institute of Medical Sciences, Tatibandh, Raipur
Raipur
CHHATTISGARH
492099
India |
| Phone |
9592916918 |
| Fax |
|
| Email |
dr.adityasomani@gmail.com |
|
|
Source of Monetary or Material Support
|
| All India Institute of Medical Sciences, Raipur |
|
|
Primary Sponsor
|
| Name |
All India Institute of Medical Sciences, Raipur |
| Address |
Tatibandh, GE Road, Raipur, Chhattisgarh, 492099 |
| Type of Sponsor |
Government medical college |
|
|
Details of Secondary Sponsor
|
|
|
Countries of Recruitment
|
India |
|
Sites of Study
|
| No of Sites = 1 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Dr Avika Gupta |
All India Institute of Medical Sciences, Raipur |
Department of Psychiatry, First Floor, C-Block, AIIMS, Tatibandh, Raipur
Raipur
CHHATTISGARH |
9711120674
avikagupta98@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institute Ethics Committee, All India Institute of Medical Sciences, Raipur, Chhattisgarh |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: F102||Alcohol dependence, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
Mobile based text messages |
After enrolment in study, all participants shall receive one session of motivational interview (brief intervention), based on WHO mhGAP Intervention Guide, version 2.0. Participants in control arm shall receive one SMS every fortnight, on Wednesday, between 9AM to 1PM, for 3 months, thanking them for their participation. |
| Intervention |
Mobile based text messages |
After enrolment in study, all participants shall receive one session of motivational interview (brief intervention), based on WHO mhGAP Intervention Guide, version 2.0. Participants in the intervention arm shall receive two messages every week, on Wednesday and Saturday, between 9 AM to 1 PM, for 3 months. These messages will consist of content motivating the patient to stay away from alcohol and encourage them to continue visiting for regular follow-ups |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
80.00 Year(s) |
| Gender |
Male |
| Details |
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 |
|
| ExclusionCriteria |
| Details |
1) 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.
4) Patient who has received in-patient treatment for alcohol dependence in the last three months |
|
|
Method of Generating Random Sequence
|
Permuted block randomization, fixed |
|
Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
|
Blinding/Masking
|
Investigator Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| To compare time to relapse in patients with alcohol dependence receiving mobile messages and treatment-as-usual with those receiving only treatment-as-usual |
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. |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
1) Time to first drink in the two groups
2) Total days of abstinence in two groups
3) Number of complications due to alcohol use among the two groups |
Participants will be followed up every month, till 3 months from recruitment |
|
|
Target Sample Size
|
Total Sample Size="100"
Sample Size from India="100"
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)
|
05/09/2025 |
| 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="6"
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 - YES
- What data in particular will be shared?
Response - Individual participant data that underlie the results reported in this article, after de-identification (text, tables, figures, and appendices).
- What additional supporting information will be shared?
Response - Study Protocol
Response - Statistical Analysis Plan
- Who will be able to view these files?
Response - Researchers who provide a methodologically sound proposal.
- For what types of analyses will this data be available?
Response - For individual participant data meta-analysis.
- By what mechanism will data be made available?
Response - Proposals should be directed to [dr.adityasomani@gmail.com].
- For how long will this data be available start date provided 10-01-2028 and end date provided 10-01-2033?
Response - Immediately following publication. No end date.
- Any URL or additional information regarding plan/policy for sharing IPD?
Additional Information - NIL
|
|
Brief Summary
|
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. |