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

62 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

Although psychological interventions exist for the prevention of PPD, a yoga-based intervention to prevent PPD among at-risk women utilizes a similar theoretical foundation (i.e., mindfulness), may be more acceptable to women of minority status, and may confer additional physical activity benefits. The purpose of this pilot study is to determine the effectiveness of using a virtually delivered prenatal yoga intervention for the prevention of PPD among at-risk women in a diverse health care system and explore preliminary factors which influence implementation of the intervention. This study has 2 phases: Phase 1 will evaluate facilitators and barriers to intervention implementation among patient, clinician, and health system stakeholders, followed by an open trial, and Phase 2 will include conducting an 8-session pilot randomized controlled trial to assess the feasibility and acceptability of the proposed prenatal yoga intervention among women with a history of depression, as well as the onset and course of PPD and mediating factors. The specific aims are to: 1) Optimize delivery of a yoga intervention within a healthcare system to prevent PPD through examining facilitators and barriers of implementation, 2) Examine feasibility, acceptability and satisfaction of the intervention within a health care system, and 3) Evaluate preliminary effectiveness of the intervention on PPD and proposed mechanisms. For Phase 1, separate focus groups with patient stakeholders and clinician and administrative stakeholders will inform intervention implementation, and an open trial to refine and optimize the intervention. For Phase 2, women with a history of depression who are 8-28 weeks pregnant will be randomized to the intervention group (n=24) or treatment-as-usual (n=24) and will complete survey measures at baseline, post-intervention, and 1 and 3 months postpartum. It is hypothesized that the intervention will be feasible and acceptable, engage women of racial/ethnic minority status, and contribute to lower rates of PPD onset. Embodiment and mindfulness are the proposed mediators. Knowledge gained from this study can support prevention efforts for PPD and improve the adverse public health impact of this disorder.

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.

Is prenatal yoga safe for pregnant women?

Research suggests that prenatal yoga is generally safe for pregnant women, with no yoga-related injuries reported in studies. It is considered feasible and acceptable, and participants have shown improvements in mood and reduced symptoms of depression and anxiety. ^{1 2 3 4 5}

How is the Prenatal Yoga treatment different from other treatments for postpartum depression?

Prenatal Yoga is unique because it combines physical activity with mindfulness, empowering pregnant women to manage depressive symptoms through self-directed goals and mindful movement, unlike traditional treatments that may rely on medication or therapy alone. ^{1 2 3 6 7}

What data supports the effectiveness of the treatment Prenatal Yoga to Prevent Postpartum Depression (PRY-D)?

Research shows that prenatal yoga can help reduce symptoms of depression and anxiety in pregnant women, and improve mindfulness and maternal-fetal attachment. Studies also indicate that yoga can be a feasible and effective alternative to medication for managing depression during pregnancy. ^{1 2 3 5 8}

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]

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]

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]

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]

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]

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 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]

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]

Citations

1. United States pubmed.ncbi.nlm.nih.gov

Yoga and social support reduce prenatal depression, anxiety and cortisol. [2022]

2. England pubmed.ncbi.nlm.nih.gov

Tai chi/yoga reduces prenatal depression, anxiety and sleep disturbances. [2021]

3. United States pubmed.ncbi.nlm.nih.gov

Innovations in the Treatment of Perinatal Depression: the Role of Yoga and Physical Activity Interventions During Pregnancy and Postpartum. [2020]

4. England pubmed.ncbi.nlm.nih.gov

Mindfulness yoga during pregnancy for psychiatrically at-risk women: preliminary results from a pilot feasibility study. [2021]

5. United States pubmed.ncbi.nlm.nih.gov

Feasibility, Acceptability, and Preliminary Effects of "Mindful Moms": A Mindful Physical Activity Intervention for Pregnant Women with Depression. [2023]

6. Austria pubmed.ncbi.nlm.nih.gov

A pilot randomized controlled trial comparing prenatal yoga to perinatal health education for antenatal depression. [2022]

7. Netherlands pubmed.ncbi.nlm.nih.gov

The effect of music, massage, yoga and exercise on antenatal depression: A meta-analysis. [2021]

8. England pubmed.ncbi.nlm.nih.gov

Yoga for prenatal depression: a systematic review and meta-analysis. [2022]