跳至主要内容
临床试验/NCT06004232
NCT06004232已完成不适用

Prenatal Yoga to Prevent Postpartum Depression (PRY-D)

Henry Ford Health System2 个研究点 分布在 1 个国家目标入组 62 人开始时间: 2025年2月26日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
已完成
入组人数
62
试验地点
2
主要终点
Edinburgh Postnatal Depression Scale

研究概览

简要总结

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.

详细描述

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.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Prevention
盲法
None

入排标准

年龄范围
18 Years 至 —(Adult, Older Adult)
性别
Female
接受健康志愿者

入选标准

  • ≥ 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

排除标准

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

研究组 & 干预措施

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).

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

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.

干预措施: Treatment as Usual (TAU) (Behavioral)

结局指标

主要结局

Edinburgh Postnatal Depression Scale

时间窗: 1-month and 3-months postpartum

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.

次要结局

  • Edinburgh Postnatal Depression Scale(1-month and 3-months postpartum)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Amy Loree

Principal Investigator

Henry Ford Health System

研究点 (2)

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