Clinical trial NCT06004232: Prenatal Yoga to Prevent Postpartum Depression
Official title: Prenatal Yoga to Prevent Postpartum Depression (PRY-D)
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Postpartum Depression
Keywords: Postpartum
Depression
Prenatal
Pregnant
Yoga
Mindfulness
Embodiment
Lead sponsor: Henry Ford Health System
Sponsor class: OTHER
Collaborators: name: National Institute of Mental Health (NIMH)
name: University of Colorado, Boulder
First posted: 2023-08-22
Enrollment: 62
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: PRY-D intervention vs treatment as usual (TAU)
Primary purpose: PREVENTION

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).

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

Primary outcomes:
measure: Edinburgh Postnatal Depression Scale
timeFrame: 1-month and 3-months postpartum
Secondary outcomes:
measure: Edinburgh Postnatal Depression Scale
timeFrame: 1-month and 3-months postpartum
Other outcomes:
Locations:
city: Detroit
country: United States
facility: Henry Ford Health
state: Michigan
Study officials:
affiliation: Henry Ford Health
name: Amy M Loree, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: Henry Ford Health
name: Sara Santarossa, PhD
role: PRINCIPAL_INVESTIGATOR
References: