Feasibility of Online Yoga With Facebook After Stillbirth

NCT04077476 | Completed

• 1 other identifier: STUDY00010215
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

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.

Conditions

Stillbirth; Post-traumatic Stress Disorder; Anxiety; Depression

Outcome Measures

Primary Outcomes (5)

• Berlin Social Support Scale

  The Berlin Social Support Scale is a 17-item inventory used to assess social support. The scale consists of 4 subscales: emotional support, instrumental support, need for support, and support seeking. The questions are rated on a 4-point Likert scale ranging from 1 (strongly disagree) to 4 (strongly agree).

  Change from baseline (week 0) to post (week 8)

• Feasibility: satisfaction survey

  Researcher-developed surveys are used to assess feasibility with questions related to satisfaction, acceptability, and demand of both study arms. Items are rated on a 5-point Likert scale ranging from 1 (lowest) to 5 (highest).

  Post (week 8)

• Impact of Events Scale-Revised

  The Impact of Events Scale-Revised (IES-R) is a 22-item inventory used to assess symptoms of post-traumatic stress disorder. The scale contains items pertaining to a person's (direct or indirect) response to a traumatic event within the past week (e.g., "I had trouble staying asleep."). The items are rated on a 5-point Likert scale from 0 (never) to 4 (extremely).

  Change from baseline (week 0) to post (week 8)

• State-Trait Anxiety Inventory

  The State-Trait Anxiety Inventory is a 40-item inventory used to assess symptoms of anxiety. The two subsections of the inventory are state-specific and trait-specific. Each item is rated on a 4-point scale from 1 (not at all) to 4 (very much so).

  Change from baseline (week 0) to post (week 8)

• Patient Health Questionnaire (PHQ-9)

  The Patient Health Questionnaire (PHQ-9) is a 9-item inventory used to assess depressive symptoms. Each item is rated on a 4-point Likert scale from 0 (not at all) to 3 (nearly every day).

  Change from baseline (week 0) to post (week 8)

Secondary Outcomes (3)

• National Cancer Institute's Multifactor Screener (diet)

  Change from baseline (week 0) to post (week 8)

• International Physical Activity Questionnaire

  Change from baseline (week 0) to post (week 8)

• Smoking/Alcohol Behavior

  Change from baseline (week 0) to post (week 8)

Study Arms (2)

Online Yoga

ACTIVE COMPARATOR

Participants in both groups will follow a prescription of classes the research team (including a 200-hour yoga instructor) developed, and is safe and appropriate for this study population. The yoga prescription will be based on the prescription used in the current R34 study (see reference for description), and modified based on results (i.e., participant feedback). Participants will be given instructions about how to use the online yoga class platform (Udaya) during the intake appointment.

Behavioral: Online Yoga

Online Yoga + Facebook

EXPERIMENTAL

In addition to what is described above, participants will be provided instructions on how to join the private Facebook group. The Facebook group will be an informal platform where participants can connect with other people in the online + SN group to share their experiences with yoga as it relates to their stillbirths. Current social media intervention research suggests careful consideration must be given to the intervention. The current intervention will be designed based on results of focus groups asking stillbirth moms who have completed an online yoga intervention what they would find helpful in a Facebook intervention. For instance, preferences included having a moderator, rules about what they can post (e.g., no "rainbow babies"), and discussion about both stillbirth and life in general.

Behavioral: Online Yoga + Facebook

Interventions

Online Yoga + Facebook BEHAVIORAL

Each week, the research team will post a prompt for discussion to encourage participation. Prompts will be developed in the beginning stages of the project based on data from the current R34 study and with guidance from consultant Waibel. Participants will be encouraged to post about their experiences with the intervention and stillbirth (emotional support), share resources, (informational support), and offer feedback and advice (appraisal support). Participants will not be required to adhere to certain criteria for engagement (e.g., number of posts, etc.), other than their weekly log in. This is to account for different types of engagement when using social networking as a means of support (e.g., posting, just reading); the benefits of each type of engagement are person-specific. The page will be moderated by members of the research team, who will post prompts and ensure content is updated and appropriate. No members can be added to the group without approval from the research team.

Online Yoga + Facebook

Online Yoga BEHAVIORAL

Participants will complete a series of videos covering basic poses and safety techniques, tracked using the Wistia plugin software. Once complete, they will be able to access the library of pre-selected classes (range in time from 10-90 minutes). Participants will be asked to complete at least 60 minutes of yoga per week; participants may choose any classes to yield 60 minutes. Preliminary data from the current R34 study suggests 60 minutes is a feasible amount of time for yoga participation. There is no upper limit to the number of minutes participants can complete.

Online Yoga

Eligibility Criteria

• Age: 18 Years+
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Arizona State University: lead

Study Sites (1)

Arizona Biomedical Collaborative

Phoenix, Arizona, 85004, United States

Location

Related Publications (11)

• 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.

  PMID: 21372060 RESULT

• 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.

  PMID: 10381705 RESULT

• 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.

  PMID: 26810220 RESULT

• 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.

  PMID: 24668767 RESULT

• 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.

  PMID: 25030795 RESULT

• 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.

  PMID: 25886805 RESULT

• 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.

  PMID: 26744309 RESULT

• 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.

  PMID: 25535016 RESULT

• 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.

  PMID: 19281517 RESULT

• 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.

  PMID: 23079176 RESULT

• 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.

  PMID: 35167361 DERIVED

MeSH Terms

Conditions

Stillbirth; Stress Disorders, Post-Traumatic; Anxiety Disorders; Depression

Condition Hierarchy (Ancestors)

Fetal Death; Pregnancy Complications; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Death; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Stress Disorders, Traumatic; Trauma and Stressor Related Disorders; Mental Disorders; Behavioral Symptoms; Behavior

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: 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.

Study Record Dates

• First Submitted: June 18, 2019
• First Posted: September 4, 2019
• Study Start: July 10, 2019
• Primary Completion: May 10, 2020
• Study Completion: May 10, 2020
• Last Updated: June 4, 2020

Record last verified: 2020-06

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)