| 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
|
|
|
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
|
|
|
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. |