Prenatal Yoga to Prevent Postpartum Depression (PRY-D)

Status: Recruiting
Location: See location...
Intervention Type: Behavioral
Study Type: Interventional
Study Phase: Not Applicable
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.

Eligibility
Participation Requirements
Sex: Female
Minimum Age: 18
Healthy Volunteers: f
View:

• ≥ 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

Locations
United States
Michigan
Henry Ford Health
RECRUITING
Detroit
Contact Information
Primary
Amy M Loree, PhD
aloree1@hfhs.org
313-874-5452
Backup
Sara Santarossa, PhD
ssantar1@hfhs.org
313-874-7960
Time Frame
Start Date: 2024-09-23
Estimated Completion Date: 2026-03
Participants
Target number of participants: 62
Treatments
Experimental: 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).
Active_comparator: 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.
Related Therapeutic Areas
Sponsors
Collaborators: University of Colorado, Boulder, National Institute of Mental Health (NIMH)
Leads: Henry Ford Health System

This content was sourced from clinicaltrials.gov