| CTRI Number |
CTRI/2021/08/035760 [Registered on: 18/08/2021] Trial Registered Prospectively |
| Last Modified On: |
23/09/2021 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
|
Type of Study
|
Behavioral |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
Online Mindfulness influences Stress, Anxiety and Depression in an Indian community |
|
Scientific Title of Study
|
An Online Mindfulness-based intervention influences Stress, Anxiety and Depression in an Indian community during the COVID-19 Pandemic: A Prospective Randomized Controlled Study |
| 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 |
48/1F, Leela Roy Sarani
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 |
48/1F, Leela Roy Sarani
Kolkata
WEST BENGAL
700019
India |
| Phone |
|
| Fax |
|
| Email |
pal.anirban1@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Anirban Pal |
| Designation |
Consultant |
| Affiliation |
Apollo Medical center |
| Address |
48/1F, Leela Roy Sarani
Kolkata
WEST BENGAL
700019
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
Kolkata 700031 |
| 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, Pin 741235
Nadia
WEST BENGAL |
9830761649
pal.anirban1@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Kalyani ESI hospital |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Healthy Human Volunteers |
Apparently Healthy |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Mindfulness-based Intervention |
Mindfulness involves group sessions using breathing exercise and relaxation techniques for a period of 4 weeks. |
| Comparator Agent |
Placebo session |
Similar sessions for 4 weeks duration but the concept of Mindfulness excluded in those sessions |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
65.00 Year(s) |
| Gender |
Both |
| Details |
informed consent obtained |
|
| ExclusionCriteria |
|
|
Method of Generating Random Sequence
|
Random Number Table |
|
Method of Concealment
|
An Open list of random numbers |
|
Blinding/Masking
|
Outcome Assessor Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Stress, Anxiety, Depression |
4 weeks |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Mindfulness |
1 month |
|
|
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)
|
01/09/2021 |
| 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 Applicable |
| Recruitment Status of Trial (India) |
Completed |
|
Publication Details
|
Not published |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
|
Brief Summary
|
60 apparently healthy individuals will be randomized into two group. One group will receive online Mindfulness-based intervention while the other group will attend similar online placebo sessions for a period of one month. The stress, anxiety and depression of the individuals are measured by Perceived stress score (PSS), Generalized Anxiety Score (GAD 7) and PHQ 9 respectively at the beginning and at the end of the study. |