| CTRI Number |
CTRI/2024/05/067176 [Registered on: 10/05/2024] Trial Registered Prospectively |
| Last Modified On: |
09/09/2024 |
| 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
|
Yoga for depression in pregnant women: a randomized controlled trial |
|
Scientific Title of Study
|
Yoga-based lifestyle intervention for Antenatal Depression (YOGA-D) |
| Trial Acronym |
YOGA-D |
|
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 |
| Phone |
00917748095634 |
| 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
MAHARASHTRA
413736
India |
| Phone |
00917748095634 |
| 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
MAHARASHTRA
413736
India |
| Phone |
00917748095634 |
| 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 |
| Pravara Institute of Medical Sciences |
Loni, India |
|
|
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 |
7748095634
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
|
|
|
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 (EUC) |
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.
The PRACTICE phase will begin after the first group session alongside the LEARN phase. We will encourage participants to start practicing as soon as possible. In the initial three weeks after the recruitment, we will request participants to practice at least one activity from the yoga sequence.
FREQUENCY: 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 along with the image, 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.
|
|
|
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
Singleton pregnancy
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 one or more spontaneous abortions
History of cervical stitch/encirclage operation
History of pre-term labor/premature rupture of members
Receiving treatment for depression or any other mental health condition
Presence of suicidal ideation (score of 3 on PHQ-9 item 9)
History of hypertension, heart disease, diabetes (including gestational diabetes), respiratory disease, severe anemia, lower respiratory tract infection
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 |
We will assess the feasibility and acceptability of the Yoga-Sanskar (YS) intervention and the preliminary efficacy of the intervention on depression in pregnant women.
Process data will inform the feasibility of the enrolment, engagement with the intervention, and completion of the intervention. The process indicators are as follows:
1. Number and proportion of eligible participants enrolled per week in the YS and the EUC arm.
2. Number and proportion of enrolled participants in the YS arm who attend the first session, three follow-up training sessions, and the final assessment session.
3. Number and proportion of enrolled participants in both arms who complete the follow-up assessment three months post-randomization.
Depression during pregnancy is the primary outcome to assess the efficacy of the intervention. We will assess depression using a culturally adapted and validated Marathi version of PHQ-9.
|
Baseline, three-months post-randomization, post-delivery |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
Anxiety
Stress
Quality of Life
Minor ailments in pregnancy
Experience of pregnancy
Attitude
Treatment Expectation
Self-Efficacy
Competence
Awareness
Satisfaction
|
Baseline, three-months post-randomization, post-delivery |
|
|
Target Sample Size
|
Total Sample Size="50"
Sample Size from India="50"
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)
|
01/06/2024 |
| 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="0"
Days="0" |
Recruitment Status of Trial (Global)
Modification(s)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Closed to Recruitment of Participants |
|
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 - All of the individual participant data collected during the trial, after de-identification.
- What additional supporting information will be shared?
Response - Study Protocol
Response - Statistical Analysis Plan
Response - Informed Consent Form
Response - Clinical Study Report
- 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.
- 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 [rahulshidhaye@gmail.com ].
- For how long will this data be available start date provided 01-12-2026 and end date provided 31-01-2032?
Response - Beginning 3 months and ending 5 years following article publication.
- Any URL or additional information regarding plan/policy for sharing IPD?
Additional Information - NIL
|
|
Brief Summary
|
The
overall aim of this pilot randomized controlled trial is to examine the
feasibility, acceptability, and preliminary efficacy of Yoga-Sanskar (YS), a
yoga-based intervention to improve antenatal depression.
The primary
objectives of this pilot randomized trial are:
1.
To estimate participant eligibility, recruitment and retention-in-care and
study completion rates.
2.
To assess the feasibility of delivering Yoga-Sanskar intervention and
acceptability of this intervention by the participants.
3.
To assess the adherence rate, safety, and preliminary efficacy of Yoga-Sanskar
intervention in improving antenatal depression (primary outcome).
The
secondary objectives of this pilot randomized trial are:
1. To
assess the preliminary efficacy of Yoga-Sanskar intervention on anxiety,
stress, and quality of life (secondary outcomes) during pregnancy.
2.
To assess the preliminary efficacy of the intervention on pregnancy outcomes (preterm
labor, type of delivery, birthweight, and post-partum depression.
3.
To explore the feasibility of administering all the evaluation tools including
the Client Service Receipt Inventory to assess the healthcare and intervention
costs.
4.
To explore the feasibility of following up recruited participants four weeks post-delivery.
5. To
study the psychometric properties of the translated versions of the Pregnancy
Experience Scale, Common Symptoms in Pregnancy inventory, Attitude towards Yoga
during Pregnancy scale, and the Five Facet Mindfulness Questionnaire-17.
Trial
design
Single-blind
individual randomized parallel group-controlled pilot trial with 1:1 allocation
ratio. |