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CTRI Number  CTRI/2025/12/098516 [Registered on: 05/12/2025] Trial Registered Prospectively
Last Modified On: 04/12/2025
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Other (Specify) [Educational]  
Study Design  Other 
Public Title of Study   Development, validation and piloting of a brief educational module on harmful effects of alcohol addiction . 
Scientific Title of Study   Development, validation and piloting of a brief educational module on harmful consequences of alcohol dependence. 
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 Bhadane Anushka Manish 
Designation  Junior resident  
Affiliation  Kasturba Medical college ,MAHE Manipal 
Address  Department of Psychiatry Kasturba Medical College , Manipal, Karnataka 576104

Udupi
KARNATAKA
576104
India 
Phone  9511826393  
Fax    
Email  bhadaneanushka13@gmail.com  
 
Details of Contact Person
Scientific Query
 
Name  Dr Ravindra Munoli 
Designation  Additional Professor ( MD Psychiatry ) 
Affiliation  Manipal Academy of Higher education ,Manipal 
Address  Department of Psychiatry Kasturba Medical College , Manipal, Karnataka 576104

Udupi
KARNATAKA
576104
India 
Phone  9972028881  
Fax    
Email  ravindra.nm@manipal.edu  
 
Details of Contact Person
Public Query
 
Name  Dr Ravindra Munoli 
Designation  Additional Professor ( MD Psychiatry ) 
Affiliation  Manipal Academy of Higher education ,Manipal 
Address  Department of Psychiatry Kasturba Medical College , Manipal, Karnataka 576104

Udupi
KARNATAKA
576104
India 
Phone  9972028881  
Fax    
Email  ravindra.nm@manipal.edu  
 
Source of Monetary or Material Support  
Kasturba Medical college ,Madhav Nagar, Near Tiger circle, Manipal - 576104, Karnataka, India 
 
Primary Sponsor  
Name  Dr. Bhadane Anushka Manish 
Address  Department of Psychiatry Kasturba Medical College , Manipal, Karnataka 576104 
Type of Sponsor  Other [Self] 
 
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 Bhadane Anushka Manish   Kasturba Hospital ,Manipal , Udupi , Karnataka  Department of Psychiatry Kasturba Medical College , Manipal, Karnataka 576104
Udupi
KARNATAKA 
9511826393

bhadaneanushka13@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
KMC and KH Institutional Ethics committee  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 
Intervention  Brief Psychoeducation session  Participants will have a single 30 minute individual psychoeducation session, conducted using the brief educational module , supplemented with visual aids such as pictures and, if feasible videos .Frequency of session - Only once for a patient . Total duration of intervention - 30mins. 
Comparator Agent  N/A  N/A 
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  65.00 Year(s)
Gender  Both 
Details  1.Inpatients with a diagnosis of Alcohol Dependence syndrome at KMC hospital .
2.Patients of either gender.
3.Patients between age 18-65 years.
4.Patients who have consented to participate in the study .
 
 
ExclusionCriteria 
Details  1.Patients not consenting or
2.unable to consent - those having severe medical condition and acute symptomatic psychosis. 
 
Method of Generating Random Sequence   Not Applicable 
Method of Concealment   Not Applicable 
Blinding/Masking   Not Applicable 
Primary Outcome  
Outcome  TimePoints 
Knowledge ,Attitude, and practice (KAP) Questionnaire - to assess change in participants knowledge ,attitude and practices regarding the harmful effects of alcohol use before and after the educational intervention .

Content Validity Index (CVI) - to evaluate content validity of the educational module . 
KAP will be assessed at 3 time points. At baseline, Immediately after the intervention will be re-administered and One month later, follow-up assessments conducted either in person or via telephone to evaluate changes in alcohol use behavior. CVI- to evaluate content validity of the educational module - will be done to validate the KAP questionnaire and also the educational module during the 1 and 2 phase respectively . 
 
Secondary Outcome  
Outcome  TimePoints 
Motivation before & after the intervention is evaluated using the Readiness to Change scale & DRIE, while the AUDIT tool helps in assessing alcohol consumption, drinking behaviors, & related problems  Assessments at 3 time points. At baseline, Alcohol Use Disorder Identification Test (AUDIT), Drinking-Related Internal & External Locus of Control (DRIE) scale, & the Readiness to Change Questionnaire (RCQ). Immediately after the intervention, DRIE, & RCQ will be re-administered to measure immediate effects. One month later, follow-up assessments will be conducted either in person or via telephone & will include RCQ, DRIE, & AUDIT  
 
Target Sample Size   Total Sample Size="30"
Sample Size from India="30" 
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)   25/12/2025 
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="1" 
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 will be conducted in three phases. In the first phase, a scoping review will be carried out using databases such as PubMed with key terms including “psychoeducation,” “alcoholism,” “alcohol,” “alcohol addiction,” and “alcohol dependence” to identify existing educational materials related to alcohol addiction. Necessary institutional permissions will be obtained to access both public and proprietary sources. All identified materials focusing on the consequences of alcohol addiction will be evaluated for accuracy, relevance, cultural suitability, and overall effectiveness. If suitable material is available, it will be adapted for use in the study; if not, a new culturally appropriate psychoeducation module will be developed. Alongside this, a Knowledge, Attitude, and Practice (KAP) questionnaire specific to alcohol addiction will be developed to assess the impact of the educational intervention. This questionnaire will be aligned with the content of the module, designed with cultural sensitivity, and reviewed by experts for content validity. Existing KAP tools in addiction medicine will be used for reference during its development. Both the educational module and the KAP questionnaire will be prepared and validated during Phase 1. In the second phase, the draft psychoeducation module will undergo expert validation. Feedback will be collected from 5 to 10 subject experts via email to evaluate the module’s accuracy, appropriateness, and comprehensiveness. Content validity will be quantified using the Content Validity Index (CVI), and necessary refinements will be made based on expert consensus. Following this, a pilot study will be conducted with five patients diagnosed with Alcohol Dependence Syndrome (ADS), selected as per ICD-11 inclusion and exclusion criteria. The draft module will be administered to these patients, and their feedback will be used to improve the clarity, feasibility, and acceptability of the intervention. In the third phase, the refined module will be implemented in a sample of 30 participants with ADS, again selected according to inclusion and exclusion criteria. Each participant will receive a single 30 minute individual psychoeducation session using the brief educational module, which will incorporate pictures and potentially videos to enhance comprehension. Fidelity measures will be applied to ensure consistent delivery of the intervention. Assessments will be conducted at three time points. At baseline, participants will complete a socio-demographic proforma, the newly developed KAP questionnaire, the Alcohol Use Disorder Identification Test (AUDIT),  Drinking-Related Internal and External Locus of Control (DRIE) scale, and the Readiness to Change Questionnaire (RCQ). Immediately after the intervention, the KAP questionnaire, DRIE, and RCQ will be re-administered to measure immediate effects. One month later, follow-up assessments will be conducted either in person or via telephone and will include the KAP questionnaire, RCQ, DRIE, and AUDIT to evaluate retention of knowledge, attitudinal changes, readiness to change, locus of control, and any changes in alcohol use behavior. Wherever necessary Kannada version of the scales will be used. Throughout the study, all participants will continue receiving standard care from the treating team, including clinical assessments, medications, psychoeducation, and other non-pharmacological treatments. The study intervention will be provided in addition to standard care.


 
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