| CTRI Number |
CTRI/2025/06/088548 [Registered on: 10/06/2025] Trial Registered Prospectively |
| Last Modified On: |
09/06/2025 |
| Post Graduate Thesis |
No |
| Type of Trial |
Observational |
|
Type of Study
|
Follow Up Study |
| Study Design |
Other |
|
Public Title of Study
|
A study to understand whether a deaddiction camp, organized in a psychiatry hospital, is helpful for coming out of addiction for the patients attending the camp |
|
Scientific Title of Study
|
recurring prospective cohort study on the processes and outcomes of a hospital-based camp approach for patients with Alcohol Use Disorders |
| Trial Acronym |
not applicable |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Soyuz John |
| Designation |
Associate Professor |
| Affiliation |
Kasturba Medical College, Manipal, Manipal Academy of Higher Education, Manipal, Karnataka |
| Address |
Department of Psychiatry, KMC Manipal
Manipal Academy of Higher Education Mahe Manipal
Udupi
KARNATAKA
576104
India |
| Phone |
8867604011 |
| Fax |
|
| Email |
soyuz.john@manipal.edu |
|
Details of Contact Person
Scientific Query
|
| Name |
Soyuz John |
| Designation |
Associate Professor |
| Affiliation |
Kasturba Medical College, Manipal, Manipal Academy of Higher Education, Manipal, Karnataka |
| Address |
Department of Psychiatry, KMC Manipal
Manipal Academy of Higher Education Mahe Manipal
KARNATAKA
576104
India |
| Phone |
8867604011 |
| Fax |
|
| Email |
soyuz.john@manipal.edu |
|
Details of Contact Person
Public Query
|
| Name |
Soyuz John |
| Designation |
Associate Professor |
| Affiliation |
Kasturba Medical College, Manipal, Manipal Academy of Higher Education, Manipal, Karnataka |
| Address |
Department of Psychiatry, KMC Manipal
Manipal Academy of Higher Education Mahe Manipal
KARNATAKA
576104
India |
| Phone |
8867604011 |
| Fax |
|
| Email |
soyuz.john@manipal.edu |
|
|
Source of Monetary or Material Support
|
| Department of Psychiatry, Kasturba Medical College, Manipal Academy of Higher education, Udupi, Manipal, Karnataka, India. 576104 |
|
|
Primary Sponsor
|
| Name |
Department of Psychiatry |
| Address |
Department of Psychiatry, Kasturba Medical college, MAHE Manipal, Udupi, Karnataka India.576104 |
| Type of Sponsor |
Private hospital/clinic |
|
|
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 Vidyashree Somashekar |
A V Baliga Memorial Hospital |
Department of Psychiatry, Room no 32, 6th Main, V. M. Nagar, Udupi, Karnataka, India 576102
Udupi
KARNATAKA |
9538886297
vidya.manibettu14@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Kasturba Medical college and Kasturba Hospital Institutional Ethics Committee |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: F101||Alcohol abuse, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Nil |
Nil |
| Comparator Agent |
Nil |
Nil |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
80.00 Year(s) |
| Gender |
Both |
| Details |
both male and female
diagnosed with alcohol use disorder
attending the hospital-based de-addiction camp |
|
| ExclusionCriteria |
| Details |
not willing to participate in the study |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| abstinence, lapse and relapse of the patients |
3 months, 6 months, 9 months and 12 months |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| pathways to care, co dependency and functionality |
3 months, 6 months, 9 months and 12 months |
|
|
Target Sample Size
|
Total Sample Size="50"
Sample Size from India="50"
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)
|
30/06/2025 |
| 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="5"
Months="0"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Yet Recruiting |
| 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
|
Aim and Objective: The study aims to understand the process and outcome of a camp based approach for the treatment of patients with Alcohol Use Disorders. Objectives are to assess the pathway to care of patients with AUD attending the camp To determine the rates of abstinence, lapses, and relapses of patients with AUD attending the camp To determine the relationship between baseline severity, functionality, psychological condition, codependency and treatment outcome of the patients with AUD attending the camp Process of the study: The study is going to follow the cohort of patient who will be attending the hospital based camp treatment for AUD. The camp happened every year at Baliga Hospital Udupi, Karnataka. As part of the study from 2025 onwards, the researchers will recruit patients from the camp every year till 2025 and follow up every cohort for one year. Tool of data collection WHO Encounter form The Alcohol Use Disorder Identification Test Patient Health Questionnaire SADS Work and Social Adjustment Scale Codependency Assessment Questionnaire |