| 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
|
|
|
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
|
|
|
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. |