Skip to main content
Clinical Trials/CTRI/2025/12/098516
CTRI/2025/12/098516Not yet recruitingNot Applicable

Development, validation and piloting of a brief educational module on harmful consequences of alcohol dependence.

Dr. Bhadane Anushka Manish1 site in 1 country30 target enrollmentStarted: December 25, 2025Last updated:

Trial Snapshot

Phase
Not Applicable
Status
Not yet recruiting
Sponsor
Enrollment
30
Locations
1

Study Overview

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.

Study Design

Study Type
Interventional
Allocation
Na
Masking
None

Eligibility Criteria

Ages
18.00 Year(s) to 65.00 Year(s) (—)
Sex
All

Inclusion Criteria

  • 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 .

Exclusion Criteria

  • 1.Patients not consenting or 2.unable to consent.
  • those having severe medical condition and acute symptomatic psychosis.

Investigators

Sponsor
Dr. Bhadane Anushka Manish
Sponsor Class
Other [self]
Responsible Party
Principal Investigator
Principal Investigator

Dr Bhadane Anushka Manish

Kasturba Medical college ,MAHE Manipal

Study Sites (1)

Loading locations...

Similar Trials