Yoga Online Feasibility to Reduce PTSD
Yoga Online: Interconception Care to Prevent PTSD Symptoms After Stillbirth
1 other identifier
interventional
90
1 country
1
Brief Summary
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for not_applicable
Started Apr 2016
Typical duration for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
April 1, 2016
CompletedFirst Submitted
Initial submission to the registry
October 4, 2016
CompletedFirst Posted
Study publicly available on registry
October 6, 2016
CompletedPrimary Completion
Last participant's last visit for primary outcome
June 1, 2019
CompletedStudy Completion
Last participant's last visit for all outcomes
June 1, 2019
CompletedAugust 29, 2019
August 1, 2019
3.2 years
October 4, 2016
August 28, 2019
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Clinically elevated levels of PTSD (according to IES-R)
12 weeks
Secondary Outcomes (10)
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
- +5 more secondary outcomes
Study Arms (3)
Low dose Yoga
EXPERIMENTAL12 week online yoga for 60 minutes per week
Moderate dose Yoga
EXPERIMENTAL12 week online yoga for 150 minutes per week
Stretch and toning
ACTIVE COMPARATOR12 week online stretching, toning exercises for 60 minutes per week
Interventions
Phase 1: Testing yoga videos for emotional regulation and self-compassion which will inform the selected videos for Phase 2 prescription Phase 2: 150 minutes of Online streaming yoga videos completed at home. Week 1/2 introductory videos that include short video clips breaking down each pose Weeks 3-12 increase in difficulty (all videos are appropriate for beginners)
Phase 1: Developing 12 week prescription for online control videos Phase 2: Online streaming stretching and toning videos completed at home which consist of a warm-up, 1 balance, 2 core, 2-3 upper body and lower body exercises, 6 stretches, cool-down
Phase 1: Testing yoga videos for emotional regulation and self-compassion which will inform the selected videos for Phase 2 prescription Phase 2: 60 minutes of Online streaming yoga videos completed at home. Week 1/2 introductory videos that include short video clips breaking down each pose Weeks 3-12 increase in difficulty (all videos are appropriate for beginners)
Eligibility Criteria
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)
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Arizona Biomedical Collaborative
Phoenix, Arizona, 85004, United States
Related Publications (2)
Huberty J, Sullivan M, Green J, Kurka J, Leiferman J, Gold K, Cacciatore J. Online yoga to reduce post traumatic stress in women who have experienced stillbirth: a randomized control feasibility trial. BMC Complement Med Ther. 2020 Jun 5;20(1):173. doi: 10.1186/s12906-020-02926-3.
PMID: 32503517DERIVEDHuberty J, Matthews J, Leiferman J, Cacciatore J, Gold KJ. A study protocol of a three-group randomized feasibility trial of an online yoga intervention for mothers after stillbirth (The Mindful Health Study). Pilot Feasibility Stud. 2017 Jul 6;4:12. doi: 10.1186/s40814-017-0162-7. eCollection 2018.
PMID: 28694991DERIVED
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- SINGLE
- Who Masked
- PARTICIPANT
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Associate Professor in the School of Nutrition and Health Promotion
Study Record Dates
First Submitted
October 4, 2016
First Posted
October 6, 2016
Study Start
April 1, 2016
Primary Completion
June 1, 2019
Study Completion
June 1, 2019
Last Updated
August 29, 2019
Record last verified: 2019-08