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CTRI Number  CTRI/2025/12/099436 [Registered on: 18/12/2025] Trial Registered Prospectively
Last Modified On: 11/12/2025
Post Graduate Thesis  No 
Type of Trial  Interventional 
Type of Study   Behavioral
Other (Specify) [Psychological]  
Study Design  Non-randomized, Active Controlled Trial 
Public Title of Study   Counselling Program to Reduce Stress, Anxiety, Depression and Improve Quality of Life in Heart Attack Patients 
Scientific Title of Study   Psychosocial Interventions to Assist Recovery in Young and Middle Aged Myocardial Infarction Patients 
Trial Acronym  NIL 
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Rahul Singh 
Designation  Research Scholar 
Affiliation  Institute of Medical Sciences, BHU 
Address  Department of Cardiology, Institute of Medical Sciences, BHU Varanasi

Varanasi
UTTAR PRADESH
221005
India 
Phone  8299762112  
Fax    
Email  rahulsingh0070@bhu.ac.in  
 
Details of Contact Person
Scientific Query
 
Name  Dr Vikas Agrawal 
Designation  Professor 
Affiliation  Institute of Medical Sciences 
Address  Department of Cardiology, Institute of Medical Sciences, BHU Varanasi

Varanasi
UTTAR PRADESH
221005
India 
Phone  9453300628  
Fax    
Email  vikky25@yahoo.com  
 
Details of Contact Person
Public Query
 
Name  Dr Vikas Agrawal 
Designation  Professor 
Affiliation  Institute of Medical Sciences 
Address  Department of Cardiology, Institute of Medical Sciences, BHU Varanasi

Varanasi
UTTAR PRADESH
221005
India 
Phone  9453300628  
Fax    
Email  vikky25@yahoo.com  
 
Source of Monetary or Material Support  
NIL 
 
Primary Sponsor  
Name  Department of Cardiology 
Address  Sir Sunderlal Hospital, Institute of Medical Sciences, Banaras Hindu University, Lanka, Varanasi, Uttar Pradesh, India. PIN 221005 
Type of Sponsor  Government medical college 
 
Details of Secondary Sponsor  
Name  Address 
NIL  NIL 
 
Countries of Recruitment     India  
Sites of Study  
No of Sites = 1  
Name of Principal Investigator  Name of Site  Site Address  Phone/Fax/Email 
Dr Vikas Agrawal  Sir Sunderlal Hospital  Room Number 19, Department of Cardiology, Faculty of Modern Medicine, Institute of Medical Sciences, Banaras Hindu University, Varanasi, Uttar Pradesh, India. PIN 221005
Varanasi
UTTAR PRADESH 
9453300628

vikky25@yahoo.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Institutional Ethics Committee IMS BHU  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: I219||Acute myocardial infarction, unspecified,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Intervention  Psychoeducation Stress Management Techniques Cognitive Behavior Therapy  2 Sessions of each Psychosocial intervention in a month for 3 months. 
Comparator Agent  Standard Medical Care  The patients from the control group will continue with their standard medical care. Only Pre and Post assessment of Depression, anxiety and stress levels along with Quality of Life will done within a gap of 3 months. 
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  60.00 Year(s)
Gender  Both 
Details  Patients with at least one MI event within a year.

Patients with insignificant level of psychosocial distress and poor quality of life.
 
 
ExclusionCriteria 
Details  Patients with age more than 60 or below 18.
Patients with other chronic health issues along with MI.
Patients with other significant mental illness along with MI.
 
 
Method of Generating Random Sequence   Not Applicable 
Method of Concealment   Not Applicable 
Blinding/Masking   Not Applicable 
Primary Outcome  
Outcome  TimePoints 
Depression, Anxiety, Stress Measured with Depression Anxiety Stress Scale before intervention where Depression score is below 20, Anxiety Score is below 14 and Stress Score is below 25. Post intervention the expected scores of Depression is below 9, Anxiety below 7 and Stress below 14.   6 weeks. 
 
Secondary Outcome  
Outcome  TimePoints 
WHO Quality of Life BREF Scale overall score below 60 before interventions and higher than 60 after interventions.  3 Months 
 
Target Sample Size   Total Sample Size="140"
Sample Size from India="140" 
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)   26/12/2025 
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="8"
Days="0" 
Recruitment Status of Trial (Global)   Not Yet Recruiting 
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 - Clinical Study Report

  3. Who will be able to view these files?
    Response - Anyone

  4. For what types of analyses will this data be available?
    Response - To achieve aims in the approved proposal.

  5. By what mechanism will data be made available?
    Response - Proposals should be directed to [rahulsingh0070@bhu.ac.in].

  6. For how long will this data be available start date provided 31-12-2026 and end date provided 31-12-2035?
    Response - Immediately following publication. No end date.

  7. Any URL or additional information regarding plan/policy for sharing IPD? 
    Additional Information - NIL
Brief Summary  
Primary Purpose of the Protocol

The primary purpose of this study is to understand whether psychosocial interventions can meaningfully support the recovery of young and middle aged patients who have experienced a myocardial infarction. Although medical treatment remains central to cardiac care, many patients continue to struggle with stress, anxiety, depression and reduced quality of life after discharge. These psychological challenges often slow recovery and may heighten the risk of future cardiac events. The protocol therefore focuses on introducing a structured psychosocial program that works alongside standard medical care to improve emotional wellbeing and overall functioning in post MI patients.

The study aims to implement three major components. The first is psychoeducation, which helps patients develop a clearer understanding of myocardial infarction, its causes and its impact on both physical and psychological health. This promotes better insight and reduces fear related to the illness. The second component includes stress management techniques such as deep breathing, progressive muscle relaxation and guided imagery. These practices are introduced to help patients regulate stress responses, improve sleep and manage everyday distress more effectively. The third component is cognitive behavioral therapy which supports patients in identifying and modifying unhelpful thoughts, fears and behavioural patterns that may interfere with recovery.

By integrating these elements into a structured intervention over a three month period, the protocol aims to observe whether participants show measurable improvement in stress, anxiety, depression and quality of life when compared to a control group receiving standard care. The study intends to generate evidence on the usefulness of psychosocial interventions in cardiac healthcare settings in India, where such approaches are not yet a routine part of secondary prevention. The findings may help strengthen multidisciplinary care models and highlight the importance of psychological support in chronic illness management.

Brief Statement of Study Hypothesis

The central hypothesis of the study is that psychosocial interventions will have a positive effect on the recovery of young and middle aged myocardial infarction patients. Specifically, it is expected that patients who receive the combined intervention of psychoeducation, cognitive behavioral therapy and stress management techniques will show a significant reduction in stress, anxiety and depressive symptoms. It is also hypothesized that their quality of life scores will improve when compared to their own baseline levels and when compared to patients receiving standard care alone. The combined effect of these interventions is expected to support better emotional adjustment, greater sense of control and improved overall wellbeing during the recovery period. This hypothesis aligns with the growing evidence that psychological and emotional factors play a meaningful role in cardiac health. The study therefore assumes that addressing these factors through structured psychosocial methods will contribute to better recovery outcomes and may support long term health benefits for myocardial infarction patients.
 
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