Prenatal Yoga for Postpartum Depression

(PRY-D Trial)

Overseen By Sara Santarossa, PhD

Age: 18+

Sex: Female

Trial Phase: Academic

Sponsor: Henry Ford Health System

Disqualifiers: Non-English speakers, Exercise restrictions

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Approved in 3 Jurisdictions This treatment is already approved in other countries

Compensation: Varies

Number of Visits: 2

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests whether yoga during pregnancy can prevent postpartum depression (PPD) in women at risk, especially those with a history of depression. Researchers aim to determine if a virtual prenatal yoga program is practical, well-received, and effective in reducing PPD among women from diverse backgrounds. Participants are divided into two groups: one will participate in eight yoga sessions, while the other will receive standard prenatal care and advice on staying active. Women who are 8-28 weeks pregnant, have a history of depression, and can attend virtual yoga sessions using an internet-enabled device may be suitable for this study. As an unphased trial, this study provides a unique opportunity to understand how yoga might benefit mental health during pregnancy.

Will I have to stop taking my current medications?

The trial information does not specify whether you need to stop taking your current medications. It is best to consult with the trial coordinators or your healthcare provider for guidance.

What prior data suggests that this prenatal yoga intervention is safe for preventing postpartum depression?

Research has shown that prenatal yoga is generally safe for pregnant women. Studies have found that yoga can help reduce stress and symptoms of depression during pregnancy. Lowering these symptoms is important because it might help prevent depression after giving birth.

Prenatal yoga is usually well-tolerated, with few reports of side effects. Most participants find it relaxing and helpful. In this trial, yoga sessions are offered online, making them more convenient. Practicing at home also reduces the risk of physical injury.

While specific safety data from this trial is not yet available, prenatal yoga is considered a low-risk activity. It is already recommended for improving mental well-being during pregnancy. For any concerns, consulting a healthcare provider is advisable. They can offer advice based on individual health needs. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about the Prenatal Yoga to Prevent Postpartum Depression (PRY-D) intervention because it offers a holistic, non-pharmaceutical approach to tackling postpartum depression. Unlike standard treatments like antidepressants or therapy, PRY-D uses prenatal yoga to potentially prevent depression before it starts. This intervention is unique because it combines physical activity with mindfulness, both known for boosting mental health, and is delivered in a supportive virtual group setting, making it accessible and community-focused. If successful, PRY-D could provide a natural and empowering option for expecting mothers to enhance their mental well-being.

What evidence suggests that prenatal yoga might be an effective treatment for postpartum depression?

Research has shown that prenatal yoga can reduce feelings of depression during pregnancy. One study found significant mental health benefits from yoga, particularly in lowering depression symptoms. Another review highlighted that exercise, such as yoga, positively affects mental well-being during and after pregnancy. In this trial, participants in the PRY-D intervention arm will engage in prenatal yoga sessions, potentially preventing postpartum depression and offering mental health and physical activity benefits to expecting mothers. ^{1 2 4 6 7}

Who Is on the Research Team?

Amy M Loree, PhD

Principal Investigator

Henry Ford Health

Sara Santarossa, PhD

Principal Investigator

Henry Ford Health

Are You a Good Fit for This Trial?

This trial is for pregnant women aged 18 or older, between 8-28 weeks gestation, with a history of depression. They must be receiving prenatal care at Henry Ford Health and have an internet-enabled device with video capability to participate in virtual yoga classes.

Inclusion Criteria

I am pregnant and between 8 to 28 weeks along.

You are receiving prenatal care at Henry Ford Health.

You have experienced depression in the past.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Phase 1: Evaluation and Open Trial

Evaluate facilitators and barriers to intervention implementation and conduct an open trial to refine and optimize the intervention.

Varies

Focus groups and interviews

Phase 2: Pilot Randomized Controlled Trial

Conduct an 8-session pilot randomized controlled trial to assess the feasibility and acceptability of the prenatal yoga intervention.

8 weeks

1 in-person visit, 7 virtual sessions

Follow-up

Participants are monitored for safety and effectiveness after treatment, with assessments at 1 and 3 months postpartum.

3 months

Post-intervention surveys at 1 and 3 months postpartum

What Are the Treatments Tested in This Trial?

Interventions

• Prenatal Yoga to Prevent Postpartum Depression (PRY-D) intervention

Trial Overview

The study tests if virtual prenatal yoga can prevent postpartum depression (PPD) among women at risk. It includes two phases: first, understanding how to best deliver the program within healthcare systems; second, a pilot randomized controlled trial comparing the yoga intervention against usual treatment.

How Is the Trial Designed?

Group I: PRY-D intervention Experimental Treatment 1 Intervention

Participants in the intervention group will complete 8 prenatal yoga sessions (1x/week) in a virtual group format. The first session will be in person, in which they will meet the instructor, connect with one another through brief introductions, receive their yoga practice materials, practice basic yoga poses, and be given the schedule for the remaining sessions, including virtual access links (e.g., Webex).

Group II: Treatment as Usual (TAU) Active Control 1 Intervention

Participants in the the TAU group will receive routine prenatal care, during which time all patients are given information on the importance of physical activity during pregnancy.

Prenatal Yoga to Prevent Postpartum Depression (PRY-D) intervention is already approved in United States, India, European Union for the following indications:

Approved in United States as Prenatal Yoga for:

• Prevention of Postpartum Depression

Approved in India as Prenatal Yoga for:

• Prevention of Postpartum Depression
• Reduction of Anxiety in Pregnancy

Approved in European Union as Prenatal Yoga for:

• Prevention of Postpartum Depression
• Improvement of Mental Health in Pregnancy

Who Is Running the Clinical Trial?

Henry Ford Health System

Lead Sponsor

Trials

334

Recruited

2,197,000+

National Institute of Mental Health (NIMH)

Collaborator

Trials

3,007

Recruited

2,852,000+

University of Colorado, Boulder

Collaborator

Trials

128

Recruited

29,600+

Published Research Related to This Trial

In a study of 92 prenatally depressed women, those who participated in a 12-week yoga program reported significantly lower levels of depression, anxiety, and physical pain compared to those in a social support group after the first session.

By the end of the study, both groups showed improvements in depression and anxiety levels, indicating that both yoga and social support can be effective interventions for prenatal and postpartum depression.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Yoga and social support reduce prenatal depression, anxiety and cortisol. Field, T., Diego, M., Delgado, J., et al.[2022]

A pilot randomized controlled trial involving pregnant women with depression found that a prenatal yoga intervention was safe and well-accepted, with no reported injuries and high fidelity to the yoga manual.

While the study did not show statistically significant differences in depression improvement between the yoga and health education groups, the results favored the yoga intervention, suggesting potential benefits that warrant further investigation in a larger trial.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

A pilot randomized controlled trial comparing prenatal yoga to perinatal health education for antenatal depression. Uebelacker, LA., Battle, CL., Sutton, KA., et al.[2022]

A 10-week mindfulness yoga (M-Yoga) program for 18 psychiatrically high-risk pregnant women significantly reduced depression symptoms and increased mindfulness and maternal-fetal attachment, indicating its potential as a non-pharmacological treatment option.

This pilot study suggests that M-Yoga is not only feasible and well-accepted but may also serve as an effective alternative or complement to traditional medication for managing prenatal mental health issues.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Mindfulness yoga during pregnancy for psychiatrically at-risk women: preliminary results from a pilot feasibility study. Muzik, M., Hamilton, SE., Lisa Rosenblum, K., et al.[2021]

A systematic review of six randomized controlled trials involving 375 pregnant women found that yoga significantly reduced levels of depression compared to standard prenatal care and other interventions, with a standardized mean difference of -0.59.

Integrated yoga, which includes physical exercises along with meditation and relaxation techniques, was particularly effective in reducing depressive symptoms, while physical-exercise-based yoga did not show significant benefits.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Yoga for prenatal depression: a systematic review and meta-analysis. Gong, H., Ni, C., Shen, X., et al.[2022]

A systematic review of randomized controlled trials found that interventions like yoga, exercise, music, and massage have low to very low evidence for reducing prenatal depression, indicating a need for more robust studies.

Among the interventions, music therapy, particularly Chinese Medicine Five Element Music, showed the most promise, while integrated yoga was more effective than simple yoga in improving prenatal depression.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The effect of music, massage, yoga and exercise on antenatal depression: A meta-analysis. Zhu, Y., Wang, R., Tang, X., et al.[2021]

Physical activity and yoga are generally acceptable and can effectively reduce depression in pregnant and postpartum women, although some studies show mixed results regarding their efficacy.

There is a need for more rigorous randomized controlled trials to determine the optimal dosage of these interventions and strategies to maintain long-term engagement among participants.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Innovations in the Treatment of Perinatal Depression: the Role of Yoga and Physical Activity Interventions During Pregnancy and Postpartum. Eustis, EH., Ernst, S., Sutton, K., et al.[2020]

In a study involving 92 pregnant women with prenatal depression, those who participated in a 12-week tai chi/yoga program showed significant reductions in overall depression scores and related symptoms compared to a waitlist control group.

The tai chi/yoga intervention also led to lower anxiety levels and improved sleep quality, suggesting it may be an effective non-pharmacological treatment for managing prenatal depression.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Tai chi/yoga reduces prenatal depression, anxiety and sleep disturbances. Field, T., Diego, M., Delgado, J., et al.[2021]

The 'Mindful Moms' intervention, a 12-week program using prenatal yoga and goal-setting, was found to be feasible and acceptable for pregnant women experiencing depressive symptoms, with positive feedback from participants.

Participants in the 'Mindful Moms' program showed significant reductions in depressive symptoms, anxiety, and perceived stress, suggesting its potential effectiveness in improving mental health during pregnancy, although further research is needed to confirm these findings.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Feasibility, Acceptability, and Preliminary Effects of "Mindful Moms": A Mindful Physical Activity Intervention for Pregnant Women with Depression. Kinser, PA., Thacker, LR., Rider, A., et al.[2023]

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