| CTRI Number |
CTRI/2026/01/101001 [Registered on: 13/01/2026] Trial Registered Prospectively |
| Last Modified On: |
12/01/2026 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
|
Type of Study
|
Behavioral |
| Study Design |
Other |
|
Public Title of Study
|
Effect of Short-Term Therapy on Behavioural Changes in People with Alcohol Dependence |
|
Scientific Title of Study
|
Inducement Factors on Alcoholic Behavioural Modifications and the Effect of Brief Cognitive Behavioural Therapy on the Inducement Factors among Patients with Alcohol Dependence Syndrome- A Mixed Methods 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 |
SABEENA M T P |
| Designation |
PhD Scholar |
| Affiliation |
Yenepoya Deemed to be University |
| Address |
Department of Psychiatry Nursing
Yenepoya Nursing College
University Road Manjanady
Mangaluru
Dakshina Kannada
KARNATAKA
575018
India |
| Phone |
7337875557 |
| Fax |
|
| Email |
sabeena.mtp@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
SABEENA M T P |
| Designation |
PhD Scholar |
| Affiliation |
Yenepoya Deemed to be University |
| Address |
Department of Psychiatry Nursing
Yenepoya Nursing College
University Road Manjanady
Mangaluru
Dakshina Kannada
KARNATAKA
575018
India |
| Phone |
7337875557 |
| Fax |
|
| Email |
sabeena.mtp@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
SABEENA M T P |
| Designation |
PhD Scholar |
| Affiliation |
Yenepoya Deemed to be University |
| Address |
Department of Psychiatry Nursing
Yenepoya Nursing College
University Road Manjanady
Mangaluru
Dakshina Kannada
KARNATAKA
575018
India |
| Phone |
7337875557 |
| Fax |
|
| Email |
sabeena.mtp@gmail.com |
|
|
Source of Monetary or Material Support
|
| Sabeena M T P
PhD Scholar
Department of Psychiatry Nursing
Yenepoya Nursing College
University Road Manjanady
Mangaluru
pin code 575018 |
|
|
Primary Sponsor
|
| Name |
Sabeena M T P |
| Address |
PhD Scholar
Department of Psychiatry Nursing
Yenepoya Nursing College University Road
Manjanady
Mangaluru
pin code 575018 |
| Type of Sponsor |
Other [Individual] |
|
|
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 Safeekh A T |
Psychaitry and de addiction wards of Father Muller Medical College Hospital |
Department of Psychiatry
Counselling room
Kankanady
Managalore
Pin code 575002
Dakshina Kannada
KARNATAKA |
9448465741
safeekh@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Father Muller 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 Cognitive Behaviour Therapy |
Brief Cognitive Behavioural Therapy will be provided for the patients with mild to moderate level of Alcoholic dependence Syndrome
steps
Step 1 Initial Assessment.
Step 2 Rapport Development and Identification of distorted thoughts and related behaviours
Step 3 Disputing irrational belief and Rational response formation
Step 4 Applying New Skills to Stressful Situations
Step 5 Maintenance
Step 6 Follow-up
6 steps of CBT will be administered to the Participants for 1 hr/ day, 6 times a week. Post-test will be conducted using the selected tools after the 20th day and 1 month after discharge. |
| Comparator Agent |
NOT APPLICABLE |
NOT APPLICABLE |
|
|
Inclusion Criteria
|
| Age From |
20.00 Year(s) |
| Age To |
45.00 Year(s) |
| Gender |
Male |
| Details |
General Criteria
1 Participants who are admitted in an in-patient setting with a diagnosis of ADS
2 Those who are aged between 20-45 years
3 Participants who are diagnosed with Nicotine Dependence Syndrome along with ADS
4 Participants who can speak, write and understand English, Malayalam or Kannada.
Phase I All the Participants attending the department of psychiatry with alcohol related disorders (till the calculated sample size will be selected
Phase II Quantitative strand
All the Participants identified with alcohol dependence syndrome from first phase
Phase II Qualitative strand
Subjects who were the parts of phase II in quantitative strand with severe alcoholic dependence syndrome till the data saturation obtained.
|
|
| ExclusionCriteria |
| Details |
Participants who are diagnosed with multiple substance abuse except Nicotine Dependence Syndrome
Patients who are diagnosed with substance-induced psychiatric illness
Patients who have Comorbidity with any psychiatric illness or withdrawal period or relapse cases
|
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
Improvement in the Quality of Life of the Patients with Alcohol Dependence Syndrome
Identify the inducement factors affecting alcoholism
|
Inducement factors will be identified using tools as well as through in-depth interviews during the first months of data collection |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Improvement in the Quality of Life of the Patients with Alcohol Dependence Syndrome |
6 steps of CBT will be administered to the Participants for 1 hr every day 6 times a week
Post test will be conducted using the selected tools after the 20th day then 1 month after discharge |
|
|
Target Sample Size
|
Total Sample Size="220"
Sample Size from India="220"
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)
|
01/02/2026 |
| 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="0"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Yet Recruiting |
| 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
|
To attain the objectives of this study, the researcher is adopting a mixed-method approach. Thus, both quantitative and qualitative approaches will be used at different phases of the study. However, the quantitative method approach will be used to derive the major findings of the study. Then, the qualitative method will be used to validate these findings. In this case, the research design used is the Sequential Explanatory Method. Along with this, the study will also use an experimental research design. The researcher uses the experimental research design to find out the benefit gained from the Brief Cognitive-Behavioural Therapy used to treat respondents with alcohol dependence syndrome. Hence, a pre-experimental research design will be used. While using it, the researcher collects necessary data from experimental group only using both pre-test and post-test data. This model is termed as One Group Pretest Post test Design. The researcher will conduct a pre test and post-test among this group and evaluate the improvement scored by the respondents while receiving the BCBT.BCBT in 6 stages will be administered to the subject for 6 days in a week followed by the follow up. Post test will be conducted at 20th day and after 1 month of discharge to assess the Quality of Life of the subjects. |