| CTRI Number |
CTRI/2025/02/080814 [Registered on: 18/02/2025] Trial Registered Prospectively |
| Last Modified On: |
11/02/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Behavioral |
| Study Design |
Non-randomized, Placebo Controlled Trial |
|
Public Title of Study
|
A clinical study to assess effectiveness of counselling intervention on aggression and quality of life among patients with alcohol abuse |
|
Scientific Title of Study
|
Effectiveness of brief intervention on aggression and quality of life among patients with Alcohol dependence syndrome |
| Trial Acronym |
nil |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
LIJI E |
| Designation |
Post graduate |
| Affiliation |
KUHS |
| Address |
Mental health nursing Department Government college of nursing
Gandhinagar kottayam
Mental health nursing Department Government college of nursing
Gandhinagar kottayam
Kottayam
KERALA
686008
India |
| Phone |
9074009840 |
| Fax |
|
| Email |
lijiantny@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
LIJI E |
| Designation |
Post graduate |
| Affiliation |
KUHS |
| Address |
Mental health Nursing Department Government college of nursing
Gandhinagar PO kottayam
Mental health Nursing Department Government college of nursing
Gandhinagar PO kottayam
Kottayam
KERALA
686008
India |
| Phone |
9074009840 |
| Fax |
|
| Email |
lijiantny@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Lini P Luke |
| Designation |
Assistant professor |
| Affiliation |
KUHS |
| Address |
Mental health nursing Department Government college of nursing
Gandhinagar PO kottayam
Mental health nursing Department Government college of nursing
Gandhinagar PO kottayam
Kottayam
KERALA
686008
India |
| Phone |
9497666608 |
| Fax |
|
| Email |
linipluke@gmail.com |
|
|
Source of Monetary or Material Support
|
| This clinical trial is self-funded by me (Liji E) and I do not have any external Financial or Material support. |
|
|
Primary Sponsor
|
| Name |
Liji E |
| Address |
Mental health nursing Department Government College of Nursing, Gandhinagar PO
Kottayam 686008 |
| Type of Sponsor |
Other [self budget] |
|
|
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 |
| Liji E |
Government Medical College Hospital |
Ward 4
Psychiatry department
Kottayam
KERALA |
09074009840
lijiantny@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| GOVT.COLLEGE OF NURSING, KOTTAYAM INSTITUTIONAL ETHICS COMMITTEE |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: H||Substance Abuse Treatment, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Brief intervention |
It refers to a structured client-client-centered non-judgemental counseling technique given to clients with alcohol dependence syndrome to motivate them to abstinence. It includes 4 counseling sessions of 20 minutes duration and psycho-education on areas like complications to alcoholism, anger management, and improving quality of life for 4 consecutive days |
| Comparator Agent |
Nil |
Nil |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
68.00 Year(s) |
| Gender |
Male |
| Details |
Patients with alcohol dependence syndrome
between age group 18-68
having a score of 29-126 on the Bussperry aggression scale
able to understand Malayalam |
|
| ExclusionCriteria |
| Details |
Patients with alcohol dependence syndrome who;
Have a comorbid psychiatric disorder
Are in a state of delirium tremens
|
|
|
Method of Generating Random Sequence
|
Other |
|
Method of Concealment
|
Other |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
Outcome Name: Median change in aggression score, Time-points: 3 weeks.
Outcome name: Median change in Quality of life score, Time-points: 3 weeks |
The outcome will be assessed at 3 weeks after the implementation of the brief intervention. |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| reduction in aggression & improvement in quality of life |
3 weeks |
|
|
Target Sample Size
|
Total Sample Size="37"
Sample Size from India="37"
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)
|
22/02/2025 |
| 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="0"
Months="1"
Days="14" |
|
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
|
a quasi-experimental study to assess the effectiveness of brief intervention on aggression and quality of life among patients with alcohol dependence syndrome. The study follows a nonpurposive sampling technique and includes 37 samples who belong to the inclusion criteria. the brief intervention is a nonjudgmental counseling technique that include four sessions of counseling for four consecutive days. A pre-test uses the Bussperry aggression tool and WHOQOL BREF 26. The post-test is done after 21 days and the effectiveness is assessed using the same tool. |