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CTRI Number  CTRI/2024/07/071393 [Registered on: 26/07/2024] Trial Registered Prospectively
Last Modified On: 25/07/2024
Post Graduate Thesis  Yes 
Type of Trial  Observational 
Type of Study   Follow Up Study 
Study Design  Other 
Public Title of Study   Follow-up study of anxiety symptoms in patients with alcohol use disorder 
Scientific Title of Study   Evaluation of anxiety symptoms in patients with alcohol use disorder and associated sociodemographic and clinical correlates: a tertiary hospital-based follow-up 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  Neha P Shenoy 
Designation  Junior resident 
Affiliation  Kasturba Hospital, Manipal 
Address  Department of Psychiatry Kasturba Hospital Madhav Nagar Manipal Udupi- 576104 Karnataka

Udupi
KARNATAKA
576104
India 
Phone  9495615449  
Fax    
Email  pnehashenoy@gmail.com  
 
Details of Contact Person
Scientific Query
 
Name  Savitha Soman 
Designation  Additional Professor 
Affiliation  Kasturba Hospital, Manipal 
Address  Department of Psychiatry Kasturba Hospital Madhav Nagar Manipal Udupi

Udupi
KARNATAKA
576104
India 
Phone  9845240653  
Fax    
Email  savitha.soman@manipal.edu  
 
Details of Contact Person
Public Query
 
Name  Savitha Soman 
Designation  Additional Professor 
Affiliation  Kasturba Hospital, Manipal 
Address  Department of Psychiatry Kasturba Hospital Madhav Nagar Manipal Udupi

Udupi
KARNATAKA
576104
India 
Phone  9845240653  
Fax    
Email  savitha.soman@manipal.edu  
 
Source of Monetary or Material Support  
Department of Psychiatry Kasturba Hospital Madhav Nagar Manipal Udupi- 576104 Karnataka 
 
Primary Sponsor  
Name  Kasturba medical college and Hospital  
Address  Madhav Nagar Manipal Udupi- 576104 Karnataka India 
Type of Sponsor  Private medical college 
 
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 
Dr Neha P Shenoy  Kasturba hospital, Manipal  Department of psychiatry Room number 33, 3rd floor, OPD block Kasturba Hospital Madhav Nagar, Manipal
Udupi
KARNATAKA 
9495615449

pnehashenoy@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Kasturba Medical College and Hospital Institutional Ethics Committee - Student Research  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: F102||Alcohol dependence,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Comparator Agent  NIL  NIL 
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  65.00 Year(s)
Gender  Both 
Details  Any patient diagnosed with alcohol use disorder coming to Kasturba Hospital Manipal and willing for follow up 
 
ExclusionCriteria 
Details  Other substance use disorders except Nicotine dependence
Patients with a comorbid diagnosis of depressive disorders and psychosis
Patients in acute alcohol withdrawal  
 
Method of Generating Random Sequence   Not Applicable 
Method of Concealment   Not Applicable 
Blinding/Masking   Not Applicable 
Primary Outcome  
Outcome  TimePoints 
To evaluate for anxiety symptoms in patients diagnosed with alcohol use disorder.  At the time of recruitment 
 
Secondary Outcome  
Outcome  TimePoints 
To study the difference in socio demographic and clinical correlates in patients with alcohol
disorder with and without anxiety symptoms.
 
at the end of study 
To check if there is any relationship between presence of anxiety symptoms and drinking
pattern at a 3 month follow period. 
At 3 months after recruitment 
 
Target Sample Size   Total Sample Size="164"
Sample Size from India="164" 
Final Enrollment numbers achieved (Total)= "164"
Final Enrollment numbers achieved (India)="164" 
Phase of Trial   N/A 
Date of First Enrollment (India)   15/08/2024 
Date of Study Completion (India) 17/03/2026 
Date of First Enrollment (Global)  Date Missing 
Date of Study Completion (Global) Date Missing 
Estimated Duration of Trial   Years="2"
Months="6"
Days="0" 
Recruitment Status of Trial (Global)   Not Applicable 
Recruitment Status of Trial (India)  Completed 
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 prospective longitudinal study aims to evaluate anxiety symptoms in patients with alcohol use disorder (AUD) and their impact on treatment outcomes. Conducted over a period of two years (July 2024 - July 2026) , the study will involve 164 patients aged 18-65 years, diagnosed with AUD as per DSM-5 criteria. The primary aim is to evaluate anxiety symptoms in patients with AUD and understanding its short term outcomes. Specific objectives include evaluating anxiety symptoms in AUD patients, comparing sociodemographic and clinical characteristics between patients with and without anxiety symptoms, and assessing the relationship between anxiety symptoms and drinking patterns over a three-month follow-up period. Inclusion criteria encompass patients of either gender, aged 18-65 years, outpatients and inpatients, who provide informed consent. Exclusion criteria include the presence of other substance use disorders (except nicotine dependence), comorbid depressive disorders or psychosis, and acute withdrawal (CIWA-Ar score >8). Justification for the study lies in the difficulty of diagnosing co-morbid anxiety disorders during initial assessment and detoxification phases, with existing literature showing inconsistent results regarding the outcomes of AUDs with co-morbid anxiety disorders. The study employs various tools including the semi-structured perfoma, Structured Clinical Interview for DSM-5 (SCID), State-Trait Anxiety Inventory (STAI-T5), Leeds Dependence Questionnaire (LDQ), Clinical Institute Withdrawal Assessment for Alcohol Scale (CIWA-Ar), Quick Drinking Screen (QDS), and Hospital Anxiety and Depression Scale (HADS) to collect data on sociodemographic details, alcohol use patterns, and anxiety levels. Although minimal risks are anticipated, primarily related to discomfort from interview questions, the study offers potential benefits by enhancing the understanding of anxiety prevalence in AUD patients, which could lead to improved management strategies for this population.
All the required permissions for using scales has been taken and translation of the scales to regional language has been done as per WHO translation guidelines. 
 
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