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CTRI Number  CTRI/2024/09/073718 [Registered on: 10/09/2024] Trial Registered Prospectively
Last Modified On: 03/10/2024
Post Graduate Thesis  No 
Type of Trial  Interventional 
Type of Study   Yoga & Naturopathy 
Study Design  Randomized, Parallel Group, Active Controlled Trial 
Public Title of Study   A study of yoga for antenatal depression in Maharastra, India.  
Scientific Title of Study   A Pragmatic Randomized Controlled Trial to assess the effectiveness and cost-effectiveness of Yoga for Antenatal Depression in Maharashtra, India (PRAGYA).  
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 Shidhaye 
Designation  Senior Research Scientist and Associate Professor of Psychiatry 
Affiliation  Pravara Institute of Medical Sciences 
Address  Clinical Trial Center, Fifth floor (New Rural Medical College Building), Research and Development Cell, Pravara Institute of Medical Sciences, Loni, India Ahmadnagar MAHARASHTRA 413736 India

Ahmadnagar
MAHARASHTRA
413736
India 
Phone  07748095634  
Fax    
Email  rahul.shidhaye@pmtpims.org  
 
Details of Contact Person
Scientific Query  
Name  Rahul Shidhaye 
Designation  Senior Research Scientist and Associate Professor of Psychiatry 
Affiliation  Pravara Institute of Medical Sciences 
Address  Clinical Trial Center, Fifth floor (New Rural Medical College Building), Research and Development Cell, Pravara Institute of Medical Sciences, Loni, India Ahmadnagar MAHARASHTRA 413736 India

Ahmadnagar
MAHARASHTRA
413736
India 
Phone  07748095634  
Fax    
Email  rahul.shidhaye@pmtpims.org  
 
Details of Contact Person
Public Query  
Name  Rahul Shidhaye 
Designation  Senior Research Scientist and Associate Professor of Psychiatry 
Affiliation  Pravara Institute of Medical Sciences 
Address  Clinical Trial Center, Fifth floor (New Rural Medical College Building), Research and Development Cell, Pravara Institute of Medical Sciences, Loni, India Ahmadnagar MAHARASHTRA 413736 India

Ahmadnagar
MAHARASHTRA
413736
India 
Phone  07748095634  
Fax    
Email  rahul.shidhaye@pmtpims.org  
 
Source of Monetary or Material Support  
DBT-Wellcome Trust India Alliance, Nishant House, 8-2-351/N/1, 2nd floor, Road No. 2, Venkateshwara Hills, Banjara Hills, Hyderabad-500034  
 
Primary Sponsor  
Name  DBT-Wellcome Trust India Alliance 
Address  Nishant House, 8-2-351/N/1, 2nd floor, Road No. 2, Venkateshwara Hills, Banjara Hills, Hyderabad - 500034 
Type of Sponsor  Government funding agency 
 
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 Rahul Shidhaye  Pravara Institute of Medical Sciences  Room/Floor: Fifth floor (New Rural Medical College Building) Department: Clinical Trial Center Division: Research and Development Cell Ahmadnagar MAHARASHTRA
Ahmadnagar
MAHARASHTRA 		 07748095634

rahul.shidhaye@pmtpims.org 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Institutional Ethics Committee, Pravara Institute of Medical Sciences   Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: F321||Major depressive disorder, singleepisode, moderate,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Comparator Agent  Enhanced Usual Care   Participants randomized to the EUC arm will receive a single health education session delivered by the Intervention Coordinator (IC). During this session, aspects related to sleep hygiene and diet during pregnancy will be discussed, and they will be encouraged to undertake regular physical activity (150 min/week). They will be provided educational leaflets containing information about physical activity, sleep, and diet during pregnancy. The IC will work with the participants to identify ways to reduce stress during pregnancy and improve social support. As per the current standard of care in the antenatal clinic of Department of Obstetrics, pregnant women are neither screened for stress nor is there any discussion about improving mental health during pregnancy. We will also offer a slightly modified yoga-based intervention in the post-partum period (six weeks after delivery) to participants in the comparison arm. FREQUENCY: Single session DURATION: 20 MINUTES 
Intervention  Yoga-Sanskar intervention for antenatal depression  Yoga-Sanskar (YS) intervention for antenatal depression YS is a type of gentle, prenatal yoga-based intervention. It is a practice of micro-circulation/body-loosening exercises (sukshma-vyayam), postures (asanas), breathing exercises (pranayama), and relaxation (shavasana) by pregnant women to improve their mental and physical health. YS intervention has two components: a core yoga sequence and several behavioral strategies to improve home practice (or self-practice) of the core yoga sequence. The two phases of the intervention are the LEARN and PRACTICE phases. In the LEARN phase, participants randomized to the intervention arm will be taught the entire core yoga sequence in a directly supervised group yoga session format by a trained yoga instructor. FREQUENCY: Three directly supervised group yoga sessions will follow the first session, preferably on three consecutive days, where the participants will learn all the activities included in the yoga sequence. DURATION: The group yoga session will be for 60 to 75 minutes. After completing the competency assessment, around second month onwards, participants will be encouraged to practice the entire yoga sequence daily (or at least half the sequence). DURATION: It depends on the participants, but we expect them to practice at least for 30 minutes per day. Multiple tools will be provided to the participants to facilitate the home practice. Yoga Journal (Yoga-Dainandini) will be the most important of these tools. It will contain a detailed day-to-day plan of home practice and images of yoga activities to be practiced each day. A QR code will be provided which will link to the YouTube video of that yoga activity. The journal will also have a section to track the participants mood, anxiety, irritability, sleep, and fatigue. A yoga manual with a detailed description of each yoga activity in the yoga sequence will be provided to the participants. This will help them see the activity on YouTube, read the description from the manual, and then practice it independently. Additional reading material will be provided to them that will contain the details related to safety and the potential benefits of yoga. In addition to the yoga practice, participants will receive educational leaflets about physical activity, sleep, and diet during pregnancy. PREGNANT WOMEN WITH HISTORY OF ONE OR TWO SPONTENEOUS ABORTIONS AND WOMEN WITH TWIN PREGNANCIES: They will practice only neck movements, hands in and out breathing, hands stretch breathing, folded leg lumbar stretch, sectional breathing, alternate nostril breathing, humming breath, and mind-sound resonance.  
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  49.00 Year(s)
Gender  Female 
Details  Adult pregnant women above 18 years of age

Gestational age between 12–26 weeks

Patient Health Questionnaire-9 (PHQ-9) score of 10 or more

Planning to stay in the study area throughout study duration (approximately four months) 
 
ExclusionCriteria 
Details  Pregnant women advised rest/restriction of physical activities/laborious tasks by their obstetrician due to medical/obstetric problems

History of recurrent spontaneous abortions (three or more)

History of cervical stitch/encirclage operation

History of pre-term labor/premature rupture of members

Multiple pregnancy (triplet or more)

Receiving treatment for mental health condition like schizophrenia, bipolar disorder

Severe depression (score of 20 or above on PHQ-9)

Presence of death wish/ suicidal thoughts almost every day (score of 3 on PHQ9 item 9)

Inability to communicate in Marathi language

Inability to attend in-person yoga sessions
 
 
Method of Generating Random Sequence   Computer generated randomization 
Method of Concealment   Sequentially numbered, sealed, opaque envelopes 
Blinding/Masking   Outcome Assessor Blinded 
Primary Outcome  
Outcome  TimePoints 
Depression during pregnancy is the primary
outcome to assess the effectiveness of the
intervention. We will assess depression using a
culturally adapted and validated Marathi version
of PHQ-9. 		 Baseline, 6 weeks post-randomization, three-months post-randomization, post-delivery. 
 
Secondary Outcome  
Outcome  TimePoints 
Anxiety (measured using the Marathi version of the Generalized Anxiety Disorder-7)

Stress (measured usign the Marathi version of the Perceived Stress Scale-14)

Quality of Life (measured using EuroQoL 5 Dimensions Score (EQ-5D-5L))

Social Support (measured using Multidimensional Scale for Perceived Social Support).

Experience of pregnancy (measured using Pregnancy Experience Scale)

Attitude (measured using Attitude towards Yoga practice during pregnancy scale)


Awareness (measured using the Marathi version of the Five Facet Mindfulness Questionnaire)

Home Practice (measured using a self-report log)

Injuries due to yoga (measured using a self-report log)


 		 Baseline, three-months post-randomization, and post-delivery  
 
Target Sample Size   Total Sample Size="336"
Sample Size from India="336" 
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 3 
Date of First Enrollment (India)   20/09/2024 
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="10"
Days="15" 
Recruitment Status of Trial (Global)
Modification(s)  		 Not Applicable 
Recruitment Status of Trial (India)  Open to Recruitment 
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

  3. Who will be able to view these files?
    Response - Researchers who provide a methodologically sound proposal.

  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 [rahulshidhaye@gmail.com ].

  6. For how long will this data be available start date provided 01-01-2027 and end date provided 31-12-2032?
    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  

A Pragmatic Randomized Controlled Trial to assess the effectiveness and cost-effectiveness of Yoga for Antenatal Depression in Maharashtra, India (PRAGYA).  

Trial Design: 

Pragmatic, single-blind, individual randomized, parallel-group, superiority trial with 1:1 allocation ratio. 

Primary Objectives:

1. To assess the effectiveness of the Yoga-Sanskar intervention on the severity of antenatal depression.

2. To assess the cost-effectiveness of the Yoga-Sanskar intervention for antenatal depression

Secondary Objectives:

1. To assess the effectiveness of the Yoga-Sanskar intervention on anxiety, stress, and quality of life (secondary outcomes) during pregnancy.

2. To assess the effectiveness of the Yoga-Sanskar intervention on pregnancy outcomes (preterm labor, type of delivery, birthweight, and post-partum depression).

 

Hypothesis:

Women with antenatal depression who practice yoga for three months during pregnancy will show greater reduction in the severity of depression measured using the Patient Health Questionnaire-9 compared to women with antenatal depression receiving Enhanced Usual Care.
 
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