| CTRI Number |
CTRI/2025/06/088899 [Registered on: 16/06/2025] Trial Registered Prospectively |
| Last Modified On: |
15/06/2025 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
|
Type of Study
|
Behavioral |
| Study Design |
Randomized, Parallel Group, Placebo Controlled Trial |
|
Public Title of Study
|
Mindfulness and group Cognitive behavioral therapy to improve mental well-being of nursing students |
|
Scientific Title of Study
|
Mindfulness and group Cognitive behavioral therapy to enhance mental well-being in nursing students: a randomized controlled trial in Indian context |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Anirban Pal |
| Designation |
Assistant Professor |
| Affiliation |
KPC Medical College and Hospital |
| Address |
20 Raja Subodh Chandra Mallick road, Jadavpur
Kolkata
WEST BENGAL
700032
India |
| Phone |
9830761649 |
| Fax |
|
| Email |
pal.anirban1@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Anirban Pal |
| Designation |
Assistant Professor |
| Affiliation |
KPC Medical College and Hospital |
| Address |
20 Raja Subodh Chandra Mallick road, Jadavpur
Kolkata
WEST BENGAL
700032
India |
| Phone |
9830761649 |
| Fax |
|
| Email |
pal.anirban1@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Anirban Pal |
| Designation |
Assistant Professor |
| Affiliation |
KPC Medical College and Hospital |
| Address |
20 Raja Subodh Chandra Mallick road, Jadavpur
Kolkata
WEST BENGAL
700032
India |
| Phone |
9830761649 |
| Fax |
|
| Email |
pal.anirban1@gmail.com |
|
|
Source of Monetary or Material Support
|
| Dr Anirban Pal
Assistant Professor
Department of Anaesthesia
KPC Medical College and Hospital
20 Raja Subodh Chandra Mallick Rd. Jadavpur, Kolkata, India
Pin 700032 |
|
|
Primary Sponsor
|
| Name |
Anirban Pal |
| Address |
KPC Medical College and Hospital
20 Raja Subodh Chandra Mallick road, Jadavpur, Kolkata |
| 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 |
| Anirban Pal |
KPC Medical College |
20 Raja Subodh Chandra Mallick road, Jadavpur, Kolkata
Kolkata
WEST BENGAL |
9830761649
pal.anirban1@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethics Committee |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Healthy Human Volunteers |
nursing students |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
group Cognitive Behavioral therapy |
5 sessions, one session each week |
| Intervention |
Mindfulness |
5 sessions. one session each week |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
25.00 Year(s) |
| Gender |
Female |
| Details |
nursing students |
|
| ExclusionCriteria |
| Details |
known psychiatric diseases |
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
|
Blinding/Masking
|
Participant, Investigator and Outcome Assessor Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Depression Anxiety Stress (DASS 21) |
Depression Anxiety Stress (DASS 21) |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Sleep |
5 weeks |
|
|
Target Sample Size
|
Total Sample Size="200"
Sample Size from India="200"
Final Enrollment numbers achieved (Total)= "0"
Final Enrollment numbers achieved (India)="0" |
|
Phase of Trial
|
Phase 1/ Phase 2 |
|
Date of First Enrollment (India)
|
30/06/2025 |
| 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="6"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Completed |
|
Publication Details
|
N/A |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
|
Brief Summary
|
200 nursing students will be randomized to undergo mindfulness, group cognitive behavioral therapy, and a sham intervention. The stress, anxiety and depression (DASS-21) of the participants were noted pre and post intervention and any change will be noted. Secondary outcome parameter will be sleep quality. |