| CTRI Number |
CTRI/2025/09/094295 [Registered on: 04/09/2025] Trial Registered Prospectively |
| Last Modified On: |
12/09/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Behavioral |
| Study Design |
Randomized, Parallel Group, Active Controlled Trial |
|
Public Title of Study
|
Mindfulness Based Cognitive Therapy and peripartum cardiomyopathy |
|
Scientific Title of Study
|
Effect of Mindfulness based cognitive therapy on psychological variables in females with Peripartum cardiomyopathy |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Gursabeen Kaur |
| Designation |
PhD scholar |
| Affiliation |
Lovely Professional University |
| Address |
Room 201 Block 18 School of liberal Arts Lovely Professional University Jalandhar Delhi GT Road
Phagwara Punjab India 144411
Ludhiana
PUNJAB
144411
India |
| Phone |
9478949093 |
| Fax |
|
| Email |
gursabeen0381@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Gursabeen Kaur |
| Designation |
PhD scholar |
| Affiliation |
Lovely Professional University |
| Address |
Room 201 Block 18 School of liberal Arts Lovely Professional University Jalandhar Delhi GT Road
Phagwara Punjab India 144411
PUNJAB
144411
India |
| Phone |
9478949093 |
| Fax |
|
| Email |
gursabeen0381@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Gursabeen Kaur |
| Designation |
PhD scholar |
| Affiliation |
Lovely Professional University |
| Address |
Room 201 Block 18 School of liberal Arts Lovely Professional University Jalandhar Delhi GT Road
Phagwara Punjab India 144411
PUNJAB
144411
India |
| Phone |
9478949093 |
| Fax |
|
| Email |
gursabeen0381@gmail.com |
|
|
Source of Monetary or Material Support
|
| Lovely Professional University |
|
|
Primary Sponsor
|
| Name |
Lovely Professional University |
| Address |
Room 201 Block 18 School of liberal Arts Lovely Professional University Jalandhar Delhi GT Road
Phagwara Punjab India 144411 |
| Type of Sponsor |
Other [Private 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 BPMishra |
Dayanand Medical College & Hospital |
Room number 108 Department of Clinical Psychology Dayanand Medical College and Hospital Tagore nagar Ludhiana
Ludhiana
PUNJAB |
7814833339
bhole46@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Research Advisory Committee (RAC) for the SOTA-ATR |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: I428||Other cardiomyopathies, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Mindfulness Based Cognitive Therapy |
MBCT uses a combination of CBT techniques and relaxation exercises where 8 weekly sessions lasting 60 minutes will be given to the experiment group |
| Comparator Agent |
Pharmacological treatment only |
Use of Pharmacological treatment as usual by the cardiologist according to the symptomatology of the patient |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
50.00 Year(s) |
| Gender |
Female |
| Details |
Diagnosis of peripartum cardiomyopathy
Age 18-50 years
Primary level education
Willingness to participate in study
Clinically Stable
|
|
| ExclusionCriteria |
| Details |
History of Intellectual disability
Comorbid psychiatric illness which requires treatment
Communication difficulties like impaired vision or hearing
Comorbidity with substance dependence
Participants within two weeks of an operation procedure to avoid the possibility of postoperative delirium
Unstable angina pectoris
Cardiogenic shock |
|
|
Method of Generating Random Sequence
|
Coin toss, Lottery, toss of dice, shuffling cards etc |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Individuals with PPCM undergoing MBCT will exhibit significantly lower levels of psychological distress compared to those not receiving psychotherapy |
eight weekly MBCT sessions |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Individuals with PPCM undergoing MBCT will report significantly higher levels of perceived control compared to those not receiving psychotherapy |
eight weekly MBCT sessions |
| Higher levels of perceived social support will be reported by PPCM individuals post MBCT compared to those not receiving psychotherapy |
eight weekly MBCT sessions |
| MBCT will significantly improve health-related quality of life |
eight weekly MBCT sessions |
|
|
Target Sample Size
|
Total Sample Size="60"
Sample Size from India="60"
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
|
Phase 1/ Phase 2 |
|
Date of First Enrollment (India)
|
05/09/2025 |
| Date of Study Completion (India) |
Applicable only for Completed/Terminated trials |
| Date of First Enrollment (Global) |
05/09/2025 |
| Date of Study Completion (Global) |
Applicable only for Completed/Terminated trials |
Estimated Duration of Trial
Modification(s)
|
Years="1"
Months="0"
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 - NO
|
|
Brief Summary
|
Peripartum cardiomyopathy PPCM is a rare but severe form of heart failure that occurs during the last month of pregnancy or within five months postpartum Female patients with PPCM often face significant psychological challenges such as psychological distress and diminished perceived control and reduced social support and compromised health related quality of life and heightened cardiac anxiety Despite advancements in clinical care interventions targeting the psychological well-being of these women remain insufficiently explored and present study aims to build on that |