Prenatal Yoga to Prevent Postpartum Depression

NCT ID: NCT06004232

Last Updated: 2025-11-13

Basic Information

• Recruitment Status: ACTIVE_NOT_RECRUITING
• Clinical Phase: NA
• Total Enrollment: 62 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2025-02-26
• Study Completion Date: 2026-03-31

Brief Summary

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.

Detailed Description

Postpartum depression (PPD) affects approximately 13% of women, contributing to poorer overall maternal psychological health, as well as adverse infant health, behavior, and emotional development. Women with a history of depression are 21 times more likely to experience PPD, which most commonly occurs within 4 weeks of delivery. Intervening in pregnancy to prevent the onset of perinatal mental health disorders can ameliorate these adverse outcomes and contribute to significant cost savings at $32,300/affected woman. Despite evidence-based prenatal preventive mental health services for depression, there are barriers to access, and these services do not offer the adjunctive benefits provided by yoga-based interventions, including shorter labor duration and increased likelihood of vaginal birth. Yoga interventions during pregnancy have been shown to significantly improve depressive symptoms in pregnancy. Yet, previous work examining prenatal yoga was not prevention-focused; prior studies of prenatal yoga for depression have only examined treatment for women with current depression or did not evaluate PPD. Because nearly half of women with a history of depression who develop PPD did not exhibit depressive symptoms in pregnancy, it is important to include this high-risk group in preventive interventions.

Yoga is more beneficial than other physical activity interventions for depression symptoms, including fatigue and stress, and PPD interventions yield greater benefits with targeted populations. Specifically, yoga may prevent PPD through embodiment-facilitated improvements in body image and increasing mindfulness. Yet, there are several gaps in examining effectiveness of yoga for preventing PPD: 1) although racial/ethnic minority women have higher rates of PPD than White women, they are significantly less likely to initiate treatment for PPD; yoga interventions may be more engaging; 2) generalizability of previous studies of prenatal yoga for depression have also been limited by excluding women with particular psychiatric disorders and/or excluding women already practicing yoga. Expanding this evidence-based practice to women vulnerable to developing PPD (i.e., those with a history of depression) within a health care system may be effective for engaging high-risk women in a preventive intervention to decrease the risk of PPD. The proposed study focuses on preventing PPD and improving generalizability by delivering a virtual prenatal yoga intervention for at-risk, racially diverse women in a health care system.

The proposed study seeks to pilot test the effectiveness of an adapted evidence-based, virtually-delivered 8-session group prenatal yoga pilot preventive intervention for women at high risk of PPD (i.e., history of depression) to assess onset and evaluate factors which influence implementation within a health care system. The intervention incorporates evidence-based integrated yoga with mindfulness and embodiment techniques (i.e., proposed mechanisms). The investigators will also promote the inclusion of individuals of racial/ethnic minority status in yoga interventions by assessing strategies for inclusion of these individuals from patient stakeholders. Pregnant participants with a history of depression will be recruited from Henry Ford Health (HFH), a metropolitan health system that delivers prenatal care for diverse women (29% non-Hispanic Black). The inclusion of patient, provider, and administrative stakeholders will inform recruitment, engagement, and delivery of the intervention, facilitating scalability and sustainability by assessing barriers and facilitators to implementation.

The specific aims are to:

1. Optimize a yoga intervention to prevent PPD within a healthcare system.

1.a. Examine facilitators and barriers of implementation. Conduct 3 focus groups with patient (n=6-10 pregnant women in each group with a history of depression) and qualitative interviews administrative (n=10-15 HFH women's health clinicians and administrators) stakeholders to assess logistics, engagement of racially/ethnically diverse women with a history of depression, and sustainability of the intervention. Phenomenological analyses will be used to analyze qualitative findings to increase patient-centeredness.

1. b. Optimize delivery. An open trial of pregnant women (n=14) will aid in refining intervention delivery.

2. Examine feasibility, acceptability, and satisfaction of the intervention within a health care system. Pregnant women (n=48) with a history of depression will be randomized to the intervention (n=24) or treatment as usual (TAU; n=24). Feasibility will be assessed by measuring enrollment, retention across follow-up time points, and engagement (e.g., attendance at yoga sessions) rates. A post-intervention survey will measure acceptability and satisfaction. The investigators hypothesize that the intervention will be effective for engaging racial/ethnic minorities and that there will be representative enrollment rates of these groups.

3. Evaluate effectiveness of the intervention on PPD and proposed mechanisms. Participants will complete measures of depression, embodiment, and mindfulness at baseline, post-intervention, and 1 and 3 months post-delivery. The investigators anticipate that the intervention group will have lower rates of PPD (primary outcome) at each follow-up time point, higher levels of mindfulness and embodiment (i.e., proposed mediators; a path), and that these mediators will be associated with reduced likelihood of PPD (b path).

Conditions

Postpartum Depression

Keywords

Postpartum; Depression; Prenatal; Pregnant; Yoga; Mindfulness; Embodiment

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: PREVENTION
• Blinding Strategy: NONE

Study Groups

PRY-D 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 Type: EXPERIMENTAL

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

Intervention Type: BEHAVIORAL

The PRY-D curriculum is a mindfulness-based prenatal yoga intervention which utilizes techniques to build both embodiment and mindfulness, and has previously been shown to reduce depression in a small sample of pregnant women with clinical depression.

Treatment as Usual (TAU)

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.

Group Type: ACTIVE_COMPARATOR

Treatment as Usual (TAU)

Intervention Type: BEHAVIORAL

TAU involves routine prenatal care, during which time all patients are given information on the importance of physical activity during pregnancy.

Interventions

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

The PRY-D curriculum is a mindfulness-based prenatal yoga intervention which utilizes techniques to build both embodiment and mindfulness, and has previously been shown to reduce depression in a small sample of pregnant women with clinical depression.

Intervention Type: BEHAVIORAL

Treatment as Usual (TAU)

TAU involves routine prenatal care, during which time all patients are given information on the importance of physical activity during pregnancy.

Intervention Type: BEHAVIORAL

Eligibility Criteria

Inclusion Criteria

• ≥ 18 years of age,
• pregnant between 8-28 weeks gestation
• receiving prenatal care at Henry Ford Health
• have a history of depression
• have an internet-enabled device with video capability for the purpose of viewing virtual yoga classes

Exclusion Criteria

• not being fluent in English since this will be required to engage in yoga classes
• physician guidance NOT to participate in exercise

• Minimum Eligible Age: 18 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: No

Sponsors

National Institute of Mental Health (NIMH)

NIH

Sponsor Role: collaborator

University of Colorado, Boulder

OTHER

Sponsor Role: collaborator

Henry Ford Health System

OTHER

Sponsor Role: lead

Responsible Party

Amy Loree

Principal Investigator

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Amy M Loree, PhD

Role: PRINCIPAL_INVESTIGATOR

Henry Ford Health

Sara Santarossa, PhD

Role: PRINCIPAL_INVESTIGATOR

Henry Ford Health

Locations

Henry Ford Health

Detroit, Michigan, United States

Countries

United States

References

Loree AM, Santarossa S, Coyne P, Haley EN, Boulay M, Pappas C, Braciszewski JM, Miller-Matero LR, Hicks LM. Virtually-delivered prenatal yoga to prevent postpartum depression (PRYD) in women with a history of depression: Protocol for an exploratory pilot randomized controlled trial. Contemp Clin Trials. 2025 Sep;156:108032. doi: 10.1016/j.cct.2025.108032. Epub 2025 Jul 28.

Reference Type: DERIVED

PMID: 40738219 (View on PubMed)

Other Identifiers

R34MH131573

Identifier Type: NIH

Identifier Source: secondary_id

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R34MH131573

Identifier Type: NIH

Identifier Source: org_study_id

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