| CTRI Number |
CTRI/2024/03/064087 [Registered on: 13/03/2024] Trial Registered Prospectively |
| Last Modified On: |
12/03/2024 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
|
Type of Study
|
Behavioral |
| Study Design |
Randomized, Parallel Group, Active Controlled Trial |
|
Public Title of Study
|
A randamised control trial to assess the efficacy of Modified emotinal resilience training as agaist standard Emotional resilience training on impluse control and adjustment among undergraduate students of health sciences. |
|
Scientific Title of Study
|
Evaluation of Comparative Efficacy of Modified Emotional Resilience Training(MERT)Vs.Standard Resilience Training on Impulse control(IC)and adjustment among undergraduate health science student:A Randamized Control Trial. |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
MAMTA CHOUDHARI (Sahu) |
| Designation |
ASSOCIATE PROFESSOR |
| Affiliation |
PT.DDUHS UNIVERSITY RAIPUR |
| Address |
Department of Mental Health Nursing, GOVERNMENT COLLEGE OF NURSING DURG CHHATTISGARH
HOUSE NO 6A, STREET NO NPA, SECTOR 9.
Durg
CHHATTISGARH
490009
India |
| Phone |
07879338552 |
| Fax |
|
| Email |
ohmmamta@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
DR VAISHALI D TENDOLKAR |
| Designation |
PROFESSOR |
| Affiliation |
DATTA MEGHE COLLEGE OF NURSING WANDONGARI-NAGPUR |
| Address |
Department of Mental Health Nursing,DATTA MEGHE COLLEGE OF NURSING WANDONGARI-NAGPUR
Nagpur
MAHARASHTRA
441110
India |
| Phone |
9850209588 |
| Fax |
|
| Email |
vaishali69.tendolkar@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
MAMTA CHOUDHARI(Sahu) |
| Designation |
ASSOCIATE PROFESSOR |
| Affiliation |
GOVERNMENT COLLEGE OF NURSING DURG |
| Address |
Department of Mental Health Nursing, GOVERNMENT COLLEGE OF NURSING DURG CHHATTISGARH
Durg
CHHATTISGARH
491001
India |
| Phone |
07879338552 |
| Fax |
|
| Email |
ohmmamta@gmail.com |
|
|
Source of Monetary or Material Support
|
| DATTA MEGHE INSTITUTE OF MEDICAL SIENCES DEEMED TO BE UNIVERSITY SAWANGI MEGHE WARDHA |
|
|
Primary Sponsor
|
| Name |
DATTA MEGHE INSTITUTE OF MEDICAL SIENCES DEEMED TO BE UNIVERSITY SAWANGI MEGHE WARDHA |
| Address |
DATTA MEGHE INSTITUTE OF MEDICAL SCIENCE DEEMED TO BE UNIVERSITY SAWANGI MEGHE WARDHA |
| Type of Sponsor |
Private medical college |
|
|
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 |
| Mamta Choudhari |
Mahatma Gandhi Ayurved Hospital & Research Centre, Salod Wardha College Wardha |
Health Science College, Salod, Wardha Maharashtra
Wardha
MAHARASHTRA |
7879338552
ohmmamta@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 2 |
| Name of Committee |
Approval Status |
| Institutional Ethics Committee, Datta Meghe Institute of medical Science (Deemed to be University) Sawangi (Meghe) Wardha |
Approved |
| Mahatma Gandhi Ayurved College, Hospital and Research center, Salod, Wardha |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Healthy Human Volunteers |
F43/ Adjustment Disorders
R45.87/ Impulsive behaviour |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
Emotional Resillience Training |
Standard Resillience Training this programme is meant for enhancing the impulse control and adjustment behaviour of young adolscents |
| Intervention |
Modified emotional Resilience trainin
|
Modified emotional Resilience training given to all students having adjustment problem and impulse control behaviour in total 8 session .Each session is performed 45 minute. |
|
|
Inclusion Criteria
|
| Age From |
17.00 Year(s) |
| Age To |
25.00 Year(s) |
| Gender |
Both |
| Details |
Students are from health science.
Students willing to participate.
Students know Hindi, English & Marathi language. |
|
| ExclusionCriteria |
| Details |
Students are less than 17 years of age will not be included in the study.
Students who are not willing to participate in study. |
|
|
Method of Generating Random Sequence
|
Other |
|
Method of Concealment
|
Other |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Modified Emotional Resilience Training developed for making the students comfortable in hostels and academics so that the universities become more student friendly. |
4 weeks |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| By getting Emotional Resilience Training, the academic performance of university students will improve and the problem of adjustment and impulsivity will reduce. |
3 yrs |
|
|
Target Sample Size
|
Total Sample Size="200"
Sample Size from India="200"
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)
|
01/04/2024 |
| 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="3"
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 (Others) - DATA IS NOT YET COLLECTED
- What additional supporting information will be shared?
Response (Others) - IEC DONE,DRC,DSCC DONE.
- Who will be able to view these files?
Response (Others) - EVERONE
- For what types of analyses will this data be available?
Response (Others) - RESEARCH PURPOSE
- By what mechanism will data be made available?
Response (Others) - OPTION
- For how long will this data be available start date provided 25-02-2020 and end date provided 26-12-2024?
Response (Others) - 3 TO 4 YRS
- Any URL or additional information regarding plan/policy for sharing IPD?
Additional Information - No additional information.
|
|
Brief Summary
|
Modified Emotional Resilience training (MERT) focuses on building an individual’s ability to cope with stress and adversity, which helps in addressing impulse control issues. Resilience therapy is based on the concept of resilience, which refers to an individual’s ability to adapt and bounce back from difficult situations. Resilience therapy aims to help individuals develop the skills and resources they need to cope with stress and adversity, including impulse control issues. MERT helps individuals adapt to changes in their environment. The goal of this training is to help individuals build resilience, the ability to bounce back from adversity and continue functioning effectively. Resilience therapy is based on the idea that resilience is not a fixed trait, but rather a set of skills that can be developed over time. Resilience therapy is an evidence-based approach that aims to enhance an individual’s ability to cope with stress and adapt to life changes. |