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CTRI Number  CTRI/2025/08/093213 [Registered on: 19/08/2025] Trial Registered Prospectively
Last Modified On: 13/08/2025
Post Graduate Thesis  No 
Type of Trial  Interventional 
Type of Study   Behavioral 
Study Design  Randomized, Parallel Group, Active Controlled Trial 
Public Title of Study   Can Short Mindfulness Programs Help Reduce Stress in ICU Family Caregivers? 
Scientific Title of Study   Effectiveness of brief Mindfulness Based Interventions (MBIs) on improving Perceived Stress among caregivers of patients in Intensive Care Settings. 
Trial Acronym  NIL 
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Dr Jigyansa Ipsita Pattnaik 
Designation  Assistant Professor 
Affiliation  Kalinga Institute of Medical Sciences, Bhubaneswar. Odisha 
Address  Department of Psychiatry, Kalinga Institute of Medical Sciences, Bhubaneswar, Odisha - 751024

Khordha
ORISSA
751024
India 
Phone  8093515161  
Fax    
Email  drjigyansaipsita@gmail.com  
 
Details of Contact Person
Scientific Query  
Name  Dr Jigyansa Ipsita Pattnaik 
Designation  Assistant Professor 
Affiliation  Kalinga Institute of Medical Sciences, Bhubaneswar. Odisha 
Address  Department of Psychiatry, Kalinga Institute of Medical Sciences, Bhubaneswar, Odisha - 751024

Khordha
ORISSA
751024
India 
Phone  8093515161  
Fax    
Email  drjigyansaipsita@gmail.com  
 
Details of Contact Person
Public Query  
Name  Dr Jigyansa Ipsita Pattnaik 
Designation  Assistant Professor 
Affiliation  Kalinga Institute of Medical Sciences, Bhubaneswar. Odisha 
Address  Department of Psychiatry, Kalinga Institute of Medical Sciences, Bhubaneswar, Odisha - 751024

Khordha
ORISSA
751024
India 
Phone  8093515161  
Fax    
Email  drjigyansaipsita@gmail.com  
 
Source of Monetary or Material Support  
KIIT University, Bhubaneswar, Odisha  
 
Primary Sponsor  
Name  Indian Council of Medical Research (ICMR) 
Address  V. Ramalingaswami Bhawan, P.O. Box No. 4911, Ansari Nagar, New Delhi - 110029, India 
Type of Sponsor  Government funding agency 
 
Details of Secondary Sponsor  
Name  Address 
Kalinga Institute of Industrial Technology KIIT  Kalinga Institute of Industrial Technology (KIIT) Deemed to be University, Patia, Bhubaneswar, Odisha, India - 751024.  
 
Countries of Recruitment     India  
Sites of Study  
No of Sites = 1  
Name of Principal Investigator  Name of Site  Site Address  Phone/Fax/Email 
Dr Jigyansa Ipsita Pattnaik  Kalinga Institute of Medical Sciences (KIMS)  Department of Psychiatry, Ground Floor, A block
Khordha
ORISSA 		 8093515161

drjigyansaipsita@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Institutional Ethics Committee, Kalinga Institute of Medical Sciences (KIMS)  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Healthy Human Volunteers  Perceived Stress, Anxiety, Depression 
 
Intervention / Comparator Agent  
Type  Name  Details 
Intervention  Mindfulness Based Interventions   Brief mindfulness based interventions (MBSR and MBCT) administered. Each session of duration 20 - 30 minutes. A total of 6 sessions.  
Comparator Agent  Psychoeducation  Psychoeducation sessions with self help materials provided.  
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  65.00 Year(s)
Gender  Both 
Details  Age of caregiver of patients in Intensive Care Setups (ICUs and HDUs) between 18 to 65 years old.
Any gender.  
 
ExclusionCriteria 
Details  Psychiatric illness, Substance abuse (except tobacco), no written consent and hospital stay less than 3 days. 
 
Method of Generating Random Sequence   Computer generated randomization 
Method of Concealment   Sequentially numbered, sealed, opaque envelopes 
Blinding/Masking   Participant and Investigator Blinded 
Primary Outcome  
Outcome  TimePoints 
Change in Perceived Stress Scale (PSS) and Hospital Anxiety and Depression Scale (HADS) scores.  The scales are administered thrice, i.e., pre-intervention (DAY 0), mid-intervention (DAY 3), and post-intervention (DAY 6).  
 
Secondary Outcome  
Outcome  TimePoints 
Salivary Cortisol and Salivary Alpha Amylase Levels.  The samples will be measured twice, i.e., pre-interventional (DAY 0) and post-interventional (DAY6) 
Accessibility of Intervention Measure (AIM) and Feasibility of Intervention Measure (FIM)  This will be done twice, i.e., mid-interventional (DAY 3) and post-interventional (DAY 6) 
 
Target Sample Size   Total Sample Size="100"
Sample Size from India="100" 
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   N/A 
Date of First Enrollment (India)   27/08/2025 
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="0"
Months="3"
Days="0" 
Recruitment Status of Trial (Global)   Not Applicable 
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
  1. What data in particular will be shared?
    Response - Individual participant data that underlie the results reported in this article, after de-identification (text, tables, figures, and appendices).

  2. What additional supporting information will be shared?
    Response -  Study Protocol
    Response -  Statistical Analysis Plan
    Response - Informed Consent Form
    Response - Clinical Study Report

  3. Who will be able to view these files?
    Response - Researchers whose proposed use of the data has been approved by an independent review committee identified for this purpose.

  4. For what types of analyses will this data be available?
    Response - For individual participant data meta-analysis.

  5. By what mechanism will data be made available?
    Response - Proposals should be directed to [drjigyansaipsita@gmail.com].

  6. For how long will this data be available start date provided 01-01-2026 and end date provided 31-12-2028?
    Response - Beginning 9 months and ending 36 months following article publication.

  7. Any URL or additional information regarding plan/policy for sharing IPD? 
    Additional Information - NIL
Brief Summary   This study aims to understand the effect of brief Mindfulness Based Interventions (MBIs) on perceived stress, anxiety and depression among family caregivers/caretakers of patients in the Intensive Care Settings including ICUs and HDUs. 
Participants in the age group of 18 - 65 year old of any gender will be included in the study. Family caretakers suffering from known psychiatric illness, substance abuse (except nicotine and tobacco), and less than 3 days of assumed hospital stay will be excluded from the study. 
Upon taking written informed consent the participants will be recruited and randomly allotted to case arm or control arm. 
The Perceived Stress Scale (PSS) and Hospital Anxiety and Depression scale (HADS) will be used to assess the effectiveness of MBIs on improving perceived stress, anxiety and depression among the caregivers as the primary objective. Biochemical markers of stress, i.e., Salivary Cortisol (SCort) and Salivary Alpha Amylase (SAA) will be assessed for pre-intervention and post-intervention levels to gauge physiological response of intervention on stress along with Feasibility and Acceptability of Intervention Measure (FIM and AIM) will be administered to both arms as the secondary objective.
Further data analysis will be done using standard SPSS software and biochemical analysis will be done using ELISA technique. 
 
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