Yoga Online: Interconception Care to Prevent PTSD Symptoms After Stillbirth
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 90
- 试验地点
- 2
- 主要终点
- Clinically elevated levels of PTSD (according to IES-R)
研究概览
简要总结
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.
详细描述
Phase 1 (pre-recruitment):
Racial/ethnic panel:
The investigators will recruit a panel of racial/ethnic minority women (African American and Hispanic women) who have experienced stillbirth (n=5) and discuss potential benefits and perceptions of yoga to inform the study. Women will be asked to complete a web-based eligibility and informed consent survey via Qualtrics. In addition, the investigators will inquire on ways to encourage enrollment of racial/ethnic minority women into the study. The investigators will use this information to potentially modify recruitment materials in phase 2. If modification for recruitment materials are needed based on interviews, the investigators will submit the modifications to the IRB at that time. Interviews will take approximately 15-20 minutes and will be conducted over the phone.
Iterative design process for yoga prescription: Before the investigators begin recruitment for the study the investigators will implement the following steps to determine the yoga prescription for the LD and MD intervention groups:
- Identify videos from existing Udaya library. Videos prescribed will be selected for qualities pertaining to selected potential mechanisms proposed in our conceptual model. Classes chosen will include detailed instruction and specific alignment cues to promote focus and attention, thus potentially reducing sensitivity to internal sensations and increase affect tolerance (emotional regulation) (e.g., press your hands into the mat in cobra pose, lift your toes during chair pose). Also slow moving classes with longer holds to encourage non-reactivity and awareness of negative thoughts or self-criticism.
- Gather a panel of women who have experienced stillbirth (n=5) and a panel of women who regularly do yoga (n=5) to review the videos (including, as appropriate, engaging in practices. Women will be asked to complete a web-based eligibility survey and informed consent via Qualtrics. Each woman will review ~9 yoga videos within a 6 week period (videos outlined in #1). Women will be asked to come into the Healthy Lifestyles Research Lab at Arizona State University on a weekly basis for 6 weeks (1-2x/week). Before and after the review, the team will actively explore if individuals feel they are connected to their body, feel emotionally regulated, and self-compassionate (see #3 below). Sessions not perceived as useful for self-compassion and emotional regulation will be replaced for the proposed study. If no previously developed videos are supportive of improving self-compassion and emotional regulation, the investigators will produce new classes (up to six 30-min classes) in partnership with Udaya.
- Have participants rate their current self-compassion and emotional regulation to gather the pre-post mean score changes for all videos. This pre-post questionnaire will take roughly 5 minutes to complete. The investigators will also ask questions during post-intervention interviews to glean further insights about the utility of the yoga sessions for improving self-compassion and emotional regulation. This process will inform the videos to be used in the future larger trial Phase 2.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Single (Participant)
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •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.
排除标准
- •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)
研究组 & 干预措施
Low dose Yoga
12 week online yoga for 60 minutes per week
干预措施: Low dose online yoga participation (Behavioral)
Moderate dose Yoga
12 week online yoga for 150 minutes per week
干预措施: Moderate Online yoga participation (Behavioral)
Stretch and toning
12 week online stretching, toning exercises for 60 minutes per week
干预措施: Stretching and toning (Behavioral)
结局指标
主要结局
Clinically elevated levels of PTSD (according to IES-R)
时间窗: 12 weeks
次要结局
- Impact of Events Survey (IES-R)(12 weeks post baseline)
- State-Trait Anxiety Inventory(12 weeks post baseline)
- Patient Health Questionnaire (PHQ-9)(12 weeks post baseline)
- Perinatal Grief Scale (PGS)(12 weeks post baseline)
- Self-Compassion Scale(12 weeks post baseline)
- Emotional Regulation Questionnaire (ERQ)(12 weeks post baseline)
- Pittsburgh Sleep Quality Index(12 weeks post baseline)
- Modifiable Activity Questionnaire (MAQ)(12 weeks post baseline)
- SF-12v2 Health Survey (SF-12)(12 weeks post baseline)
- Mindfulness Attention Awareness Scale (MAAS)(12 weeks post baseline)
研究者
Jennifer Huberty
Associate Professor in the School of Nutrition and Health Promotion
Arizona State University