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Clinical Trial Summary

The purpose of this study is to investigate the feasibility and effectiveness on PTSD symptoms of the addition of a Facebook group to an online yoga intervention for women following a stillbirth.


Clinical Trial Description

Each year in the United States, over 26,000 women experience a stillbirth (death of a fetus ≥20 weeks of gestation). Stillbirth moms are six times more likely to develop post-traumatic stress disorder (PTSD) and four times more likely to have anxiety and depressive symptoms than moms who have live births. Stillbirth moms also experience poor sleep, lack of support, and disenfranchised grief. The negative effects of a stillbirth may last for years and may negatively impact subsequent pregnancies; many get pregnant within a year after their loss.

There is currently no standard of care for women who have experienced a stillbirth. Recommended treatment after a stillbirth typically includes medication and referral to support groups and therapists. While medication may be helpful to some women, others may be averse to medication. Support groups, if not catered to bereaved moms, may trigger post-traumatic stress symptoms. Other barriers may inhibit participation in outside the home treatment after stillbirth, such as seeing babies or having to explain their stillbirths, as reported in one study.

Yoga may be a complementary strategy to help mothers cope with post-traumatic stress. Evidence suggests yoga may improve physical and mental health (e.g., anxiety, depressive symptoms) in various populations who experience trauma (e.g., war veterans, abuse victims). Research suggests those who participate in yoga are likely to exhibit healthier behaviors (i.e., physical activity, healthy diet, abstain from alcohol/substance abuse). Yoga is safe and feasible for pregnant and post-partum women. Although yoga may be an effective strategy for PTSD following a stillbirth, due to the barriers these mothers experience, attending yoga classes at a studio may not be feasible.

Online interventions are growing in popularity and may be a way to overcome barriers to participation in treatment for stillbirth moms. Investigators are currently conducting a feasibility study to explore the use of online yoga to improve PTSD in stillbirth moms (NIH#R34AT008808). Data collection will be complete in May, 2019. Supplemental to this study, investigators conducted interviews with stillbirth moms who have finished the intervention. A brief view of the data from these interviews suggest women liked the online platform but felt isolated and wanted more social interaction during the intervention.

When an intervention is delivered online (e.g., through social networking: engaging in social interactions though online platforms), the natural social interaction that happens during in-person interventions is lacking. Research suggests giving and receiving support is an adaptive coping strategy to reduce PTSD symptoms, anxiety, and depressive symptoms. Stillbirth moms who perceived adequate levels of social support had significantly lower anxiety and depression levels than those who did not. There is a need to explore the feasibility of online interventions that include social networking to determine the relationship between online interventions and social support, and how social support acts as a mediator between social networking and PTSD, anxiety, depressive symptoms, and health behaviors.

Interventions that include a Facebook component have been shown to effectively improve social support, however little is known about the optimal structure of this type of intervention. One research study asserts existing social media platforms (e.g., Facebook) as ideal because members are familiar with the platform's social norms (e.g., how to post, "like," and comment). There is a need to explore the feasibility of a social networking component (i.e., Facebook) in addition to an online yoga intervention and the effects this might have on social support as well as PTSD, anxiety, depressive symptoms and health behaviors.

Therefore, the purpose of this study is to:

1. Examine the feasibility (acceptability, demand) of a social networking component (i.e., Facebook) to an eight-week online yoga intervention for a future U01 application.

2. Explore the preliminary effects (i.e., not powered for effects) of a social networking component (i.e., Facebook) added to an eight-week online yoga intervention on social support.

3. Explore the mechanism (i.e., social support) by which social networking may impact PTSD symptoms, anxiety, depressive symptoms and health behaviors (i.e., physical activity, diet, smoking, and alcohol consumption). ;


Study Design


Related Conditions & MeSH terms


NCT number NCT04077476
Study type Interventional
Source Arizona State University
Contact
Status Completed
Phase N/A
Start date July 10, 2019
Completion date May 10, 2020

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