| CTRI Number |
CTRI/2021/04/032716 [Registered on: 09/04/2021] Trial Registered Prospectively |
| Last Modified On: |
15/08/2021 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Preventive |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
Nurse led brief resilience intervention among college going adolescents
|
|
Scientific Title of Study
|
A randomised controlled trial on the effectiveness of nurse led brief resilience intervention program on mental health of students studying selected educational institutions of Rohtak’ |
| Trial Acronym |
Resilience intervention programme |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| nil |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Shabnam kadian |
| Designation |
Msc nursing student |
| Affiliation |
pt bd sharma university of health science rohtak |
| Address |
Department of Psychiatric Nursing, College of Nursing PGIMS Rohtak
Department of Psychiatric Nursing, College of Nursing PGIMS Rohtak
Rohtak
HARYANA
124001
India |
| Phone |
9588594973 |
| Fax |
|
| Email |
shabnamkadian07@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
JAISON JOSEPH |
| Designation |
LECTURER(JR) |
| Affiliation |
pt bd sharma university of health science rohtak |
| Address |
Department of Psychiatric Nursing, College of Nursing PGIMS Rohtak
Department of Psychiatric Nursing, College of Nursing PGIMS Rohtak
Rohtak
HARYANA
124001
India |
| Phone |
9468277298 |
| Fax |
|
| Email |
jaisonjsph@yahoo.com |
|
Details of Contact Person
Public Query
|
| Name |
JAISON JOSEPH |
| Designation |
LECTURER(JR) |
| Affiliation |
pt bd sharma university of health science rohtak |
| Address |
Department of Psychiatric Nursing, College of Nursing Rohtak
Department of Psychiatric Nursing, College of Nursing Rohtak
Rohtak
HARYANA
124001
India |
| Phone |
9468277298 |
| Fax |
|
| Email |
jaisonjsph@yahoo.com |
|
|
Source of Monetary or Material Support
|
|
|
Primary Sponsor
|
| Name |
PtBD Sharma PGIMS Rohtak |
| Address |
College of Nursing, Pt.BD Sharma PGIMS, Medical road, Rohtak, Haryana 124001 |
| Type of Sponsor |
Government 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 |
| JAISON JOSEPH |
Pt BD Sharma university of health science rohtak |
College of Nursing, Department of Psychiatric Nursing, PGIMS, Rohtak
Rohtak
HARYANA |
9468277298
jaisonjsph@yahoo.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| biomedicalresearchethicscommittee,PGIMS,ROHTAK |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Healthy Human Volunteers |
College Students |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
nurse led brief resilience intervention |
Two sessions with two weeks interval in which the post assessment was taken immediately after the second session (session-1 bolstering resilience
session-2 bolstering resilience setting goals and bouncing back). The duration of each session is 15 minutes |
| Comparator Agent |
routine advice |
Routine advice with pamphlet and two assessment were taken with two weeks interval |
|
|
Inclusion Criteria
|
| Age From |
16.00 Year(s) |
| Age To |
22.00 Year(s) |
| Gender |
Both |
| Details |
The study include who are:
1.Students studying selected educational institutions in the age group of 16-22 years.
2.Students who were interested to participate in the research study
|
|
| ExclusionCriteria |
| Details |
1.Students who are sick and not able to provide data.
2.Absent at the time of data collection
|
|
|
Method of Generating Random Sequence
|
Coin toss, Lottery, toss of dice, shuffling cards etc |
|
Method of Concealment
|
An Open list of random numbers |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
| To assess the mental health outcomes before and after a resilience intervention |
At baseline and after 2weeks |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| to assess the psychological status according to PHQ-4 |
at baseline and after 2weeks |
|
|
Target Sample Size
|
Total Sample Size="220"
Sample Size from India="220"
Final Enrollment numbers achieved (Total)= "220"
Final Enrollment numbers achieved (India)="220" |
|
Phase of Trial
|
N/A |
|
Date of First Enrollment (India)
|
15/04/2021 |
| Date of Study Completion (India) |
31/05/2021 |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
Date Missing |
|
Estimated Duration of Trial
|
Years="0"
Months="1"
Days="10" |
Recruitment Status of Trial (Global)
Modification(s)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Completed |
Publication Details
Modification(s)
|
Preparing for publication |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
Brief Summary
Modification(s)
|
This RCT is on the effectiveness of nurse led brief resilience intervention program on mental health of students studying selected educational institutions of Rohtak. The purpose of the study is to assess the effectiveness of educational institutions based brief resilience interventions for improving mental health of adolescents.
|