Clinical Trial Details
— Status: Not yet recruiting
Administrative data
| NCT number |
NCT06004232 |
| Other study ID # |
R34MH131573 |
| Secondary ID |
R34MH131573 |
| Status |
Not yet recruiting |
| Phase |
N/A
|
| First received |
|
| Last updated |
|
| Start date |
July 2024 |
| Est. completion date |
March 2026 |
Study information
| Verified date |
August 2023 |
| Source |
Henry Ford Health System |
| Contact |
Amy M Loree, PhD |
| Phone |
313-874-5452 |
| Email |
aloree1[@]hfhs.org |
| Is FDA regulated |
No |
| Health authority |
|
| Study type |
Interventional
|
Clinical Trial 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.
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 a separate focus group
of administrative (n=6-10 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=12) 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).
