Prenatal Yoga to Prevent Postpartum Depression

NCT06004232 | Active Not Recruiting DMC

• 1 other identifier: R34MH131573
• Study Type: interventional
• Target: 62
• Locations: 1 country
• Sites: 1

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.

Conditions

Postpartum Depression

Keywords

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

Outcome Measures

Primary Outcomes (1)

• Edinburgh Postnatal Depression Scale

  The Edinburgh Postnatal Depression Scale (EPDS) will be used to measure presence of postpartum depression (yes/no). EPDS scores range from 0 to 30; a score of 10 or above indicates the presence of current depression symptoms.

  1-month and 3-months postpartum

Secondary Outcomes (1)

• Edinburgh Postnatal Depression Scale

  1-month and 3-months postpartum

Study Arms (2)

PRY-D intervention

EXPERIMENTAL

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).

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

Treatment as Usual (TAU)

ACTIVE COMPARATOR

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.

Behavioral: Treatment as Usual (TAU)

Interventions

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

PRY-D intervention

Treatment as Usual (TAU) BEHAVIORAL

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

Treatment as Usual (TAU)

Eligibility Criteria

• Age: 18 Years+
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• ≥ 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

You may not qualify if:

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

Sponsors & Collaborators

• Henry Ford Health System: lead
• National Institute of Mental Health (NIMH): collaborator
• University of Colorado, Boulder: collaborator

Study Sites (1)

Henry Ford Health

Detroit, Michigan, 48202, United States

Location

Related Publications (1)

• 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.

  PMID: 40738219 DERIVED

MeSH Terms

Conditions

Depression, Postpartum; Depression

Interventions

Methods; Therapeutics

Condition Hierarchy (Ancestors)

Puerperal Disorders; Pregnancy Complications; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Depressive Disorder; Mood Disorders; Mental Disorders; Behavioral Symptoms; Behavior

Intervention Hierarchy (Ancestors)

Investigative Techniques

Study Officials

• Amy M Loree, PhD

  Henry Ford Health

  PRINCIPAL INVESTIGATOR

• Sara Santarossa, PhD

  Henry Ford Health

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Model Details: PRY-D intervention vs treatment as usual (TAU)

Study Record Dates

• First Submitted: August 16, 2023
• First Posted: August 22, 2023
• Study Start: February 26, 2025
• Primary Completion: March 1, 2026
• Study Completion: March 1, 2026
• Last Updated: November 13, 2025

Record last verified: 2025-11

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF, ANALYTIC CODE
• Time Frame: Data will become available within 1 year after the main trial paper is published, and will be available for a period of 5 years.
• Access Criteria: The data sharing agreement will include (1) a commitment to using the data only for research purposes and not to identify any individual participant; (2) a commitment to securing the data using appropriate computer technology; (3) a commitment to destroying or returning the data after analyses are completed; and (4) a brief written plan for how the data will be used. Furthermore, users must agree to the conditions of use governing access to the data, including reporting responsibilities, restrictions on redistribution of the data to third parties, and proper acknowledgement of the data resource.

Locations

US (1)