| CTRI Number |
CTRI/2025/03/081635 [Registered on: 04/03/2025] Trial Registered Prospectively |
| Last Modified On: |
04/03/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Preventive
Screening
Behavioral |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
Brief Intervention for Alcohol and Problematic Internet Use: A Clinical Trial |
|
Scientific Title of Study
|
Effect of brief intervention on patients with alcohol use with problematic internet use compared to treatment as usual- A randomized controlled trial |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Shahla |
| Designation |
Academic junior resident psychiatry |
| Affiliation |
AIIMS Gorakhpur |
| Address |
Room no 231
Department of Psychiatry
AIIMS Gorakhpur
Gorakhpur
UTTAR PRADESH
273008
India |
| Phone |
00917306707031 |
| Fax |
|
| Email |
shahlasubair123@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Richa Tripathi |
| Designation |
Associate professor , Dept of Psychiatry , AIIMS Gorakhpur |
| Affiliation |
AIIMS Gorakhpur |
| Address |
Room No 233
Dept of Psychiatry
AIIMS Gorakhpur
AIIMS Gorakhpur
Gorakhpur
UTTAR PRADESH
273008
India |
| Phone |
09999457412 |
| Fax |
|
| Email |
drricha12@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Richa Tripathi |
| Designation |
Associate professor , Dept of Psychiatry |
| Affiliation |
AIIMS Gorakhpur |
| Address |
Room No 233
Dept of psychiatry
AIMS Gorakhpur
Dept of Psychiatry
AIIMS Gorakhpur
Gorakhpur
UTTAR PRADESH
273008
India |
| Phone |
09999457412 |
| Fax |
|
| Email |
drricha12@gmail.com |
|
|
Source of Monetary or Material Support
|
| All India Institute of Medical Science (AIIMS), Gorakhpur
Uttar Pradesh , India
pin code : 273008 |
|
|
Primary Sponsor
|
| Name |
All India Institute of Medical Science Gorakhpur |
| Address |
AIIMS Kunraghat , Gorakhpur
Uttar pradesh , India
pin code :273008 |
| Type of Sponsor |
Research institution and hospital |
|
|
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 Shahla |
AIIMS Gorakhpur |
Room No 233
Dept of Psychiatry
AIIMS Gorakhpur
AIIMS Gorakhpur
Gorakhpur
UTTAR PRADESH |
07306707031
shahlasubair123@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethics Committee |
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 Intervention |
Brief intervention over course of 3 brief counselling session of 5-30 mins each |
| Comparator Agent |
Treatment as usual |
Pharmacological and Non pharmacological intervention as usual |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Male |
| Details |
patients with alcohol use disorder of any severity as per DSM 5and problematic internet use defined as a score of more than 22 on PIUQ 9 |
|
| ExclusionCriteria |
| Details |
patients with history of any other substance use in moderate to high ASSIST risk category except nicotine
No alcohol use in past 12 months
Any acute conditions hampering clinical interview
Diagnosis of Psychosis currently or in past
|
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
An Open list of random numbers |
|
Blinding/Masking
|
Participant and Outcome Assessor Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| To evaluate effectiveness of motivational interviewing based brief intervention in reducing alcohol use and problematic internet use in patients with alcohol use compared to treatment as usual |
4 times
1)on day of screening
2)after 14 days
3)after 60 days
4)after 90 days |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
To observe prevalence of problematic internet use in alcohol use disorder
To observe correlates of problematic internet use in patients with alcohol use disorder
to observe agebased differences in alcohol use and problematic internet use in patients with alcohol use disorder |
4 times |
|
|
Target Sample Size
|
Total Sample Size="60"
Sample Size from India="60"
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)
|
15/03/2025 |
| 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="2"
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
|
The study is a longitudinal study with two arms.The intervention arm will consist of brief intervention and routine pharmacological management (treatment as usual ).The control arm will consist of non structured counselling and routine pharmacological management (treatment as usual ).There will be three sessions of brief intervention at baseline , day 14 and day 30 .participant will be evaluated at day 60 and day 90 by an independent assessor who will be blinded about intervention and control group |