| CTRI Number |
CTRI/2024/10/075993 [Registered on: 28/10/2024] Trial Registered Prospectively |
| Last Modified On: |
13/10/2024 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Behavioral |
| Study Design |
Other |
|
Public Title of Study
|
An intervention study to find out the effectiveness of brief psychodynamic therapy on psychological mindedness, defense mechanisms, and socio-occupational functioning in individuals with Alcohol Dependence Syndrome. |
|
Scientific Title of Study
|
Looking at Alcohol Dependence Syndrome Through Psychodynamic Lens:
Application of Supportive-Expressive Dynamic Therapy
|
| Trial Acronym |
nil |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Muhammed Sadik T M |
| Designation |
PhD Scholar |
| Affiliation |
Kazi Nazrul University |
| Address |
Department of Applied Psychology
Barddhaman
WEST BENGAL
713340
India |
| Phone |
9946547606 |
| Fax |
|
| Email |
sdk.alt@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Shuvabrata Poddar |
| Designation |
Assistant Professor |
| Affiliation |
Kazi Nazrul University |
| Address |
Department of Applied Psychology,
Room No. - 208, Bidya-Charcha Bhavan, Kazi Nazrul University
Barddhaman
WEST BENGAL
713340
India |
| Phone |
7549089680 |
| Fax |
|
| Email |
shuvabrata.poddar@knu.ac.in |
|
Details of Contact Person
Public Query
|
| Name |
Muhammed Sadik T M |
| Designation |
PhD Scholar |
| Affiliation |
Kazi Nazrul University |
| Address |
Department of Applied Psychology
Barddhaman
WEST BENGAL
713340
India |
| Phone |
9946547606 |
| Fax |
|
| Email |
sdk.alt@gmail.com |
|
|
Source of Monetary or Material Support
|
| Muhammed Sadik TM
PhD Scholar, Department of Applied Psychology, Kazi Nazrul University, Asansol, West bengal-713340 |
|
|
Primary Sponsor
|
| Name |
nil |
| Address |
nil |
| Type of Sponsor |
Research institution |
|
|
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 Abdul Gafoor |
Maadin Institute of Mental Health And Rehabilitation |
Room no. 03, Department of Clinical Psychology,
Centre for deaddiction
Malappuram
KERALA |
9847470311
gafoorasadi@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| HUMAN REASEARCH ETHICS COMMITTEE KAZI NAZRUL UNIVERSITY |
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 PSYCHODYNAMIC THERAPY |
Duration of One month |
| Comparator Agent |
Treatment As Usual (TAU) |
On month duration |
|
|
Inclusion Criteria
|
| Age From |
25.00 Year(s) |
| Age To |
35.00 Year(s) |
| Gender |
Both |
| Details |
Diagnoses of mental and behavioural disorder due to use of alcohol, currently using the substance (active dependence) as per Diagnostic Criteria for Research, ICD 10–DCR (WHO, 1993) both Inpatient and outpatient
All gender
undergone detoxification
giving written informed consent
minimum of 2 years of dependence
minimum 8th-grade education
|
|
| ExclusionCriteria |
| Details |
No previous exposure to psychodynamic therapy
Use of other substance in harmful/ dependence pattern except caffeine and nicotine
Those having intellectual disability
Patients who are having complicated withdrawal symptoms
Those having Terminal/neurological illness
|
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| There is an improvement in social and occupation functioning, psychological mindedness after receiving the proposed intervention. |
at post assessment (4 weeks ) and Follow up assessment (12 weeks) |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| CHANGES IN PSYCHODYNAMIC COMPONENTS |
3 MONTHS |
|
|
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
|
Phase 2 |
|
Date of First Enrollment (India)
|
01/11/2024 |
| Date of Study Completion (India) |
Applicable only for Completed/Terminated trials |
| Date of First Enrollment (Global) |
01/11/2024 |
| 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 - YES
- What data in particular will be shared?
Response - Individual participant data that underlie the results reported in this article, after de-identification (text, tables, figures, and appendices).
- What additional supporting information will be shared?
Response - Study Protocol
Response - Statistical Analysis Plan
Response - Informed Consent Form
Response - Clinical Study Report
Response - Analytic Code
Response (Others) -
- Who will be able to view these files?
Response - Researchers whose proposed use of the data has been approved by an independent review committee identified for this purpose.
- For what types of analyses will this data be available?
Response - To achieve aims in the approved proposal.
- By what mechanism will data be made available?
Response - Proposals should be directed to [sdk.alt@gmail.com].
- For how long will this data be available start date provided 25-11-2024 and end date provided 26-07-2029?
Response - Beginning 3 months and ending 5 years following article publication.
- Any URL or additional information regarding plan/policy for sharing IPD?
Additional Information - nil
|
|
Brief Summary
|
The study is a randomized controlled study, focusing on the effectiveness of brief psychodynamic therapy on psychological mindedness, ego function, ego functions and social and occupational functioning. In this study, the patients of alcohol dependence syndrome will be randomly allocated into two experimental and control group. The experimental group will be receiving the proposed intervention and TAU by control group. There will be significant improvement in the above mentioned variables after receiving the proposed intervention as compared to Control group. |