| 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
|
|
|
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
|
|
|
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
|
|
|
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
- 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).
- What additional supporting information will be shared?
Response - Study Protocol Response - Statistical Analysis Plan Response - Clinical Study Report
- Who will be able to view these files?
Response - Anyone
- For what types of analyses will this data be available?
Response - To achieve aims in the approved proposal.
- By what mechanism will data be made available?
Response - Proposals should be directed to [rahulsingh0070@bhu.ac.in].
- 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.
- 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. |