Yoga Online Feasibility to Reduce PTSD

Completed · Not applicable

Conditions studied: PTSD

In brief

Each year more than 26,000 pregnancies in the United States end in stillbirth (late fetal death at \>20 weeks of gestation). A 2011 issue of the Lancet, dedicated entirely to stillbirth, recognized it as a "too-often-ignored" public health problem despite occurring once in every 160 pregnancies. The death of a baby is highly traumatic and can incite negative mental, emotional, and physical health consequences lasting years after the loss. Bereaved mothers with stillbirth have a 4-fold higher risk of depression and 6-fold higher risk for post-traumatic stress disorder (PTSD). These mental health consequences are likely to negatively affect subsequent pregnancies, many of which occur within the first year after loss (50-98%). Inter-conception care is provided to women of reproductive age between pregnancies; however, few interventions focus on PTSD symptomatology and its related comorbidities in bereaved mothers. Treatment for bereaved mothers may include psychiatric medication and/or referral to support groups. Because bereaved mothers with stillbirth may have additional mental and physical health risks, pharmacological interventions are typically a first and sole line of treatment and may not sufficiently allay bereaved mothers' emotional distress. Moreover, women may be trying to conceive or may have already conceived and report reticence to taking medication. Additionally, support groups with little emphasis on coping may not be helpful for some grieving mothers. Non-pharmacological approaches, such as yoga, may be an alternative option for bereaved women with stillbirth. Yoga has been established as an effective, safe, acceptable, and cost effective approach to improving mental health in a variety of populations, including pregnant and post-partum women. Yoga has also been used as a means to cope with PTSD associated with surviving a traumatic event (i.e., interpersonal violence, military veterans). The investigators are unaware of any studies that have explored yoga to reduce PTSD in bereaved mothers with stillbirth. Furthermore, online streaming yoga (on-demand videos played in the home) has recently grown in popularity and may address the unique barriers that women experiencing stillbirth may have. To reduce PTSD symptoms and its co-morbid conditions (i.e., anxiety and depression) the investigators propose to develop and test the feasibility and acceptability of a home-based, online streamed yoga intervention (www.udaya.com) for bereaved mothers with stillbirth.

Key facts

Study ID

NCT02925481

Run by

Arizona State University

People needed

90

Starts

2016-04-01

Expected to finish

2019-06-01

Last updated by the study team

2019-08-29

Who can join

Age: 18 and older. Sex: female. Healthy volunteers: not accepted.

You may qualify if…

• Women who experienced stillbirth (\>20 wks gestation) within past 24 mos
• Clinical levels posttraumatic stress symptoms (\>33 as measured by the IES-R)
• ≥ 18 yrs of age
• Residing in U.S.
• Able to read/understand English
• Underactive (≤120 mins/wk moderate intensity PA)
• Willing to be randomized
• Answer "no" to all items on PA Readiness Questionnaire (can participate safely), or if a woman answers "yes" to one or more questions on the PAR-Q, she will be asked to obtain medical clearance from her physician prior to participation in the study. Women will be given two options in which to demonstrate medical clearance (a) bring a form provided by the study team to their health care provider to obtain a signature from a physician and then email, fax, or mail the signed medical clearance form to the research personnel, or (b) sign and fax a release of information form to research personnel, who will then send the medical clearance form directly to their designated health care providers' office to obtain a physician signature.

You may not qualify if…

• Unstable psychiatric condition (psychosis; suicidal ideation with plan)
• Pregnant at time of enrollment
• Practicing yoga at least 60 mins/wk
• Unwilling to be randomized to a group.
• At risk for suicide based on follow-up phone assessment by a trained contact person under supervision of Dr. Cacciatore after positive screen
• (PHQ-9 score of 1, 2, or 3)

Where it is running

• Arizona Biomedical Collaborative — Phoenix, Arizona, United States

Full record on ClinicalTrials.gov

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