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CTRI Number  CTRI/2024/03/064831 [Registered on: 27/03/2024] Trial Registered Prospectively
Last Modified On: 15/09/2025
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Preventive
Behavioral 
Study Design  Randomized, Parallel Group, Active Controlled Trial 
Public Title of Study   Mindfulness for New Moms: Boosting Well Being and Work Transition 
Scientific Title of Study   Effect of Digital Mindfulness Based Cognitive Therapy on Postpartum Depression, Well Being, and Resuming Work 
Trial Acronym  NIL 
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Sreenath Kuruveettissery 
Designation  Assistant Professor 
Affiliation  CHRIST (Deemed to be University) 
Address  Rm. 546, R&D Block, Department of Psychology, School of Social Sciences, CHRIST (Deemed to be University), Bangalore Central Campus, Hosur Main Road, Bhavani Nagar, Bangalore

Bangalore
KARNATAKA
560029
India 
Phone    
Fax    
Email  sreenath.k@christuniversity.in  
 
Details of Contact Person
Scientific Query  
Name  Sreenath Kuruveettissery 
Designation  Assistant Professor 
Affiliation  CHRIST (Deemed to be University) 
Address  Rm. 546, R&D Block, Department of Psychology, School of Social Sciences, CHRIST (Deemed to be University), Bangalore Central Campus, Hosur Main Road, Bhavani Nagar, Bangalore

Bangalore
KARNATAKA
560029
India 
Phone    
Fax    
Email  sreenath.k@christuniversity.in  
 
Details of Contact Person
Public Query  
Name  Neda Ansaari 
Designation  Research Scholar 
Affiliation  CHRIST (Deemed to be University) 
Address  Rm. 546, R&D Block, Department of Psychology, School of Social Sciences, CHRIST (Deemed to be University), Bangalore Central Campus, Hosur Main Road, Bhavani Nagar, Bangalore

Bangalore
KARNATAKA
560029
India 
Phone  9923311724  
Fax    
Email  neda.ansaari@res.christuniversity.in  
 
Source of Monetary or Material Support  
CHRIST (Deemed to be University), Hosur Main Road, Bhavani Nagar, Bangalore, KA-560029 
Cloudnine Hospital, Jayanagar, Bangalore, Karnataka 
 
Primary Sponsor  
Name  Sreenath Kuruveettissery 
Address  CHRIST (Deemed to be University), Hosur Main Road, Bhavani Nagar, Bangalore, KA-560029 
Type of Sponsor  Other [SELF] 
 
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 Aruna Muralidhar  Cloudnine Hospital  Department of Obstetric and Gynecology, 1533, 1st Floor, 9th Main Rd, Bairasandra Extension, Jaya Nagar 1st Block, Jayanagar 3rd Block, Jayanagar, Bengaluru, Karnataka 560011
Bangalore
KARNATAKA 		 9686115530

drarunam@cloudninecare.com 
 
Details of Ethics Committee
Modification(s)  
No of Ethics Committees= 6  
Name of Committee  Approval Status 
Apollo Cradle & Childrens Hospital  No Objection Certificate 
Greenoak Initiative  Approved 
IEC, Kids Clinic India Ltd, Cloudnine Hospital  Approved 
Janani Clinic  No Objection Certificate 
Research Conduct and Ethics Committee- CHRIST (Deemed to be University)  Approved 
Trinity Healthcare Clinic  No Objection Certificate 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Healthy Human Volunteers  Preventive intervention for perinatal and postpartum depression 
 
Intervention / Comparator Agent  
Type  Name  Details 
Comparator Agent  Control Group  Enhanced Treatment as Usual (ETAU) The Control Group (enhanced treatment-as-usual) will receive routine treatment from their gynecologist along with psychoeducational materials on mental health. The control group will not receive the Digital MBCT-PD intervention  
Intervention  Experimental Group  Digital Mindfulness Based Cognitive Therapy (MBCT-PD) This is a type of therapy that combines mindfulness techniques (like focusing on the present moment) with cognitive therapy (which helps change negative thinking patterns). In this study, a digital version of this therapy is being used to see if it helps pregnant women avoid postpartum depression and feel better overall. The intervention would consist of 8 Therapy Sessions (1-hour) over Google Meet in Group format, which will be led by a therapist. The original intervention (Dimidjian & Goodman, 2019) has been modified to include planning and preparation for return to work. Participants in the intervention group will also receive meditation audio guides to practice mindfulness at home and work. Intervention group will also receive weekly reminders on email/whatsapp from the therapist to practice the skills they learnt during MBCT-PD. The intervention will continue along with their routine treatment from the gynecologist. 
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  60.00 Year(s)
Gender  Female 
Details  Participants have to be older than 18 years of age, in 16-32 weeks of healthy gestational period, and working full time (hybrid, remote or from office). Participants fluent in English would be eligible to participate in the study. Primiparous and Multiparous women would be eligible to participate in the study. 
 
ExclusionCriteria 
Details  Women with diagnosis of gestational diabetes or gestational hypertension would be excluded from the study. Women pregnant with twins would be excluded from the study. Women with suicidal ideations, diagnosis of Bipolar disorder and Psychotic Disorders, and diagnosis of Major Depressive Disorder would be excluded from the study. Women on antidepressants or anxiolytics medications would be excluded from the study.  
 
Method of Generating Random Sequence   Stratified block randomization 
Method of Concealment   On-site computer system 
Blinding/Masking   Not Applicable 
Primary Outcome  
Outcome  TimePoints 
Depression: Depression in Perinatal and Postpartum Stages will be evaluated using Edinburgh Postnatal Depression Scale (EPDS).
Overall Well Being: The Pregnancy Experiences Scale-Brief Version (PES-Brief) assesses maternal exposures to daily uplifts and hassles specific to pregnancy.
Motivation at work: Motivation at work will be measured using Multidimensional Work Motivation Scale (MWMS)
 		 Assessment scores will be obtained at baseline (before intervention), T1 (after intervention), and T2 (6 weeks after childbirth).

 
 
Secondary Outcome  
Outcome  TimePoints 
Mindfulness levels: The evaluation of mindfulness skills will involve the use of the Three Facet Mindfulness Questionnaire-Short Form (TFMQ-SF).
Adherence to Protocol: Using a combination of several questions, adherence to the MBCT protocol would be evaluated.  		 Assessment scores will be obtained at baseline (before intervention), T1 (after intervention), and T2 (6 weeks after childbirth).  
 
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   Phase 1 
Date of First Enrollment (India)   15/04/2024 
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="1"
Months="2"
Days="20" 
Recruitment Status of Trial (Global)
Modification(s)  		 Closed to Recruitment of Participants 
Recruitment Status of Trial (India)  Closed to Recruitment of Participants 
Publication Details
Modification(s)  		 https://doi.org/10.1016/j.mhp.2025.200392 https://doi.org/10.1080/21507686.2025.2494511 
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

  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 - To achieve aims in the approved proposal.

  5. By what mechanism will data be made available?
    Response - Proposals should be directed to [neda.ansaari@res.christuniversity.in].

  6. For how long will this data be available start date provided 15-07-2025 and end date provided 15-07-2030?
    Response - Beginning 3 months and ending 5 years following article publication.

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

In the absence of preventive measures for postpartum depression, women find it challenging to resume work after childbirth. The existing literature, while recognizing the importance of preventive measures and wellness programs for working mothers, lacks a comprehensive exploration of the effectiveness of MBCT in this specific context. This study will investigate the efficacy of Digital Mindfulness-Based Cognitive Therapy (MBCT-PD) for prevention of Postpartum Depression, enhancement of well being and motivation to resume work after childbirth. A randomized controlled trial (RCT) design with repeated measures will be used to evaluate the effectiveness of modified and digital MBCT-PD to prevent postpartum depression. A sample of 80 consenting pregnant women (between 16-32 weeks of gestation) aged 18 years and above will be enrolled and randomized to the experimental (Digital MBCT) or control (enhanced treatment as usual) condition. Depression scores will be measured through Edinburgh Postnatal Depression Scale (EPDS), overall well being will be measured using Pregnancy Experience Scale (PES-Brief), and motivation to resume work will be measured through Multidimensional Work Motivation Scale (MWMS). Assessment scores will be obtained from both groups at baseline (T1), immediately following the intervention (T2), and at six weeks postpartum (T3). Descriptive statistics will be used to describe sample characteristics. Repeated measures ANOVA and regression analysis would be conducted to understand the effect of the intervention on the outcomes. The proposed research aligns with the growing body of evidence supporting the benefits of mindfulness-based interventions, providing a critical contribution to the field of perinatal mental health and workplace well-being. This research aspires to provide valuable insights into the potential benefits of MBCT for pregnant working women, informing future intervention strategies and workplace policies.

 
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