Clinical trial NCT04077476: Feasibility of Online Yoga With Facebook After Stillbirth
Official title: Feasibility of Online Yoga Plus Social Support to Improve Elevated PTS in Mothers Who Have Experienced Stillbirth
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Stillbirth
Post-traumatic Stress Disorder
Anxiety
Depression
Lead sponsor: Arizona State University
Sponsor class: OTHER
First posted: 2019-09-04
Enrollment: 60
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: The study design is a randomized control trial with baseline and post-intervention (8 wks from baseline) assessments. Participants are randomized into either an online yoga group or an online yoga plus Facebook group.
Primary purpose: TREATMENT

Brief 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.

Detailed 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).

Eligibility criteria: Inclusion Criteria:

* Women
* Ages 18+
* Had a stillbirth within the past 3 years
* Can safely participate in exercise as determined by the Physical Activity Readiness Questionnaire (PAR-Q): Answer "no" to all items on PAR-Q (can participate safely)
* Not currently practicing yoga: Operationally defined as participating ≥60 minutes per week within the past 6 months
* Have symptoms of PTSD (\>24 on the Impact of Events Scale-Revised (IES-R), which is classified as "PTSD is a clinical concern."
* Not pregnant at the time of the intervention
* Have, or be willing to create, a Facebook account
* Willing to be randomized
* Able to read and understand English

Exclusion Criteria:

* Unstable psychiatric condition (score of 20-27 on the Patient Health Questionnaire (PHQ-9)), determined by a licensed clinical social worker
* Suicidal ideation (answer 1, 2, or 3 on the last question of the PHQ-9), determined by a licensed clinical social worker
* Previous participation in a study by the research team

Primary outcomes:
measure: Berlin Social Support Scale
timeFrame: Change from baseline (week 0) to post (week 8)
measure: Feasibility: satisfaction survey
timeFrame: Post (week 8)
measure: Impact of Events Scale-Revised
timeFrame: Change from baseline (week 0) to post (week 8)
measure: State-Trait Anxiety Inventory
timeFrame: Change from baseline (week 0) to post (week 8)
measure: Patient Health Questionnaire (PHQ-9)
timeFrame: Change from baseline (week 0) to post (week 8)
Secondary outcomes:
measure: National Cancer Institute's Multifactor Screener (diet)
timeFrame: Change from baseline (week 0) to post (week 8)
measure: International Physical Activity Questionnaire
timeFrame: Change from baseline (week 0) to post (week 8)
measure: Smoking/Alcohol Behavior
timeFrame: Change from baseline (week 0) to post (week 8)
Other outcomes:
Locations:
city: Phoenix
country: United States
facility: Arizona Biomedical Collaborative
state: Arizona
Study officials:
References:
citation: Blackmore ER, Cote-Arsenault D, Tang W, Glover V, Evans J, Golding J, O'Connor TG. Previous prenatal loss as a predictor of perinatal depression and anxiety. Br J Psychiatry. 2011 May;198(5):373-8. doi: 10.1192/bjp.bp.110.083105. Epub 2011 Mar 3.
citation: Hughes PM, Turton P, Evans CD. Stillbirth as risk factor for depression and anxiety in the subsequent pregnancy: cohort study. BMJ. 1999 Jun 26;318(7200):1721-4. doi: 10.1136/bmj.318.7200.1721.
citation: Ellis A, Chebsey C, Storey C, Bradley S, Jackson S, Flenady V, Heazell A, Siassakos D. Systematic review to understand and improve care after stillbirth: a review of parents' and healthcare professionals' experiences. BMC Pregnancy Childbirth. 2016 Jan 25;16:16. doi: 10.1186/s12884-016-0806-2.
citation: Mitchell KS, Dick AM, DiMartino DM, Smith BN, Niles B, Koenen KC, Street A. A pilot study of a randomized controlled trial of yoga as an intervention for PTSD symptoms in women. J Trauma Stress. 2014 Apr;27(2):121-8. doi: 10.1002/jts.21903. Epub 2014 Mar 25.
citation: Park CL, Riley KE, Bedesin E, Stewart VM. Why practice yoga? Practitioners' motivations for adopting and maintaining yoga practice. J Health Psychol. 2016 Jun;21(6):887-96. doi: 10.1177/1359105314541314. Epub 2014 Jul 16.
citation: Buttner MM, Brock RL, O'Hara MW, Stuart S. Efficacy of yoga for depressed postpartum women: A randomized controlled trial. Complement Ther Clin Pract. 2015 May;21(2):94-100. doi: 10.1016/j.ctcp.2015.03.003. Epub 2015 Apr 1.
citation: Naslund JA, Aschbrenner KA, Marsch LA, Bartels SJ. The future of mental health care: peer-to-peer support and social media. Epidemiol Psychiatr Sci. 2016 Apr;25(2):113-22. doi: 10.1017/S2045796015001067. Epub 2016 Jan 8.
citation: McAlpine H, Joubert L, Martin-Sanchez F, Merolli M, Drummond KJ. A systematic review of types and efficacy of online interventions for cancer patients. Patient Educ Couns. 2015 Mar;98(3):283-95. doi: 10.1016/j.pec.2014.11.002. Epub 2014 Nov 18.
citation: Cacciatore J, Schnebly S, Froen JF. The effects of social support on maternal anxiety and depression after stillbirth. Health Soc Care Community. 2009 Mar;17(2):167-76. doi: 10.1111/j.1365-2524.2008.00814.x.
citation: Cavallo DN, Tate DF, Ries AV, Brown JD, DeVellis RF, Ammerman AS. A social media-based physical activity intervention: a randomized controlled trial. Am J Prev Med. 2012 Nov;43(5):527-32. doi: 10.1016/j.amepre.2012.07.019.
citation: Sullivan M, Huberty J, Green J, Cacciatore J. Adding a Facebook Support Group to an Online Yoga Randomized Trial for Women Who Have Experienced Stillbirth: A Feasibility Study. J Integr Complement Med. 2022 Feb;28(2):179-187. doi: 10.1089/jicm.2021.0097. Epub 2022 Jan 11.