| CTRI Number |
CTRI/2022/02/040662 [Registered on: 28/02/2022] Trial Registered Prospectively |
| Last Modified On: |
27/05/2022 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
|
Type of Study
|
Behavioral |
| Study Design |
Non-randomized, Placebo Controlled Trial |
|
Public Title of Study
|
Mindfulness for Indian college students |
|
Scientific Title of Study
|
Online Mindfulness to deal with stress during COVID-19 Pandemic: A Mixed Method Study in Indian college Students |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Anirban Pal |
| Designation |
Consultant |
| Affiliation |
Apollo Medical center |
| Address |
Department of Anaesthesia and pain medicine,
Apollo Medical center,
48/1F Leela Roy Sarani
48/1F Leela Roy Sarani,
Kolkata 700019
Kolkata
WEST BENGAL
700019
India |
| Phone |
|
| Fax |
|
| Email |
pal.anirban1@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Anirban Pal |
| Designation |
Consultant |
| Affiliation |
Apollo Medical center |
| Address |
43/6/5 Jheel road
48/1F Leela Roy Sarani,
Kolkata 700019
WEST BENGAL
700031
India |
| Phone |
|
| Fax |
|
| Email |
pal.anirban1@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Anirban Pal |
| Designation |
Consultant |
| Affiliation |
Apollo Medical center |
| Address |
43/6/5 Jheel road
48/1F Leela Roy Sarani,
Kolkata 700019
WEST BENGAL
700031
India |
| Phone |
|
| Fax |
|
| Email |
pal.anirban1@gmail.com |
|
|
Source of Monetary or Material Support
|
|
|
Primary Sponsor
|
| Name |
Anirban Pal |
| Address |
43/6/5 Jheel road, |
| 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 |
| Anirban Pal |
Kalyani ESI Hospital |
Department of public health
Kalyani
Nadia
WEST BENGAL |
09830761649
pal.anirban1@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Kalyani ESI hospital |
No Objection Certificate |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Healthy Human Volunteers |
No comorbidities |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Online Mindfulness program |
5 sessions online Mindfulness with one session each week. Total duration is 5 weeks. |
| Comparator Agent |
Usual Care sessions |
5 usual care sessions, one session each week. Total duration is 5 weeks. |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
25.00 Year(s) |
| Gender |
Both |
| Details |
college students |
|
| ExclusionCriteria |
| Details |
Major comorbidities |
|
|
Method of Generating Random Sequence
|
Random Number Table |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Outcome Assessor Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Perceived Stress score |
5 weeks |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| NIL |
NIL |
|
|
Target Sample Size
|
Total Sample Size="60"
Sample Size from India="60"
Final Enrollment numbers achieved (Total)= "0"
Final Enrollment numbers achieved (India)="0" |
|
Phase of Trial
|
N/A |
|
Date of First Enrollment (India)
|
15/03/2022 |
| Date of Study Completion (India) |
Date Missing |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
Date Missing |
|
Estimated Duration of Trial
|
Years="0"
Months="2"
Days="0" |
Recruitment Status of Trial (Global)
Modification(s)
|
Not Yet Recruiting |
| Recruitment Status of Trial (India) |
Completed |
|
Publication Details
|
No such |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
|
Brief Summary
|
60 college students will be randomized to attend 5 online Mindfulness sessions (case group) or usual care sessions. Their perceived stress scores will be recorded pre-program and post-program and any difference will be noted. |