StillbirthNCT04077476
Feasibility of Online Yoga With Facebook After Stillbirth
A study testing Online Yoga + Facebook and Online Yoga in people with Stillbirth and Post-traumatic Stress Disorder, run by Arizona State University at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older, women onlyHealthy volunteers can take part
- Conditions the study is for
- Stillbirth, Post-traumatic Stress Disorder, Anxiety
- What is being tested?
- Online Yoga + Facebook and Online Yoga
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 siteUnited States
- Study dates
- 10 Jul 2019to 10 May 2020
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- Women only
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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."
Show all 10Show fewer
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
United States1 site
Arizona Biomedical Collaborative
Phoenix, Arizona, 85004
About this study
Official title: Feasibility of Online Yoga Plus Social Support to Improve Elevated PTS in Mothers Who Have Experienced Stillbirth
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.
Read the 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:
- 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.
- 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.
- 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).
- Conditions
- Stillbirth, Post-traumatic Stress Disorder, Anxiety, Depression
- Being tested
- Online Yoga + Facebook, Online Yoga
- Medical subject headings
- Stillbirth, Stress Disorders, Post-Traumatic, Anxiety Disorders, Depression
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Online Yoga + FacebookBehavioural
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 YogaBehavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: Behavioral: Online Yoga + Facebook |
What is being measured
The primary outcome is the main question the study is designed to answer.
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).
Measured: 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).
Measured: 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).
Measured: 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).
Measured: 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).
Measured: Change from baseline (week 0) to post (week 8)
Secondary outcomes (3)
National Cancer Institute's Multifactor Screener (diet)
The National Cancer Institute's Multifactor Screener is a 16-item inventory used to assessed diet. It contains questions about how often respondents eat and drink certain foods or drinks. Items are rated on a 9-point Likert scale with "Never" and "4 or more times per day" as anchors.
Measured: Change from baseline (week 0) to post (week 8)
International Physical Activity Questionnaire
The International Physical Activity Questionnaire (IPAQ) is a 7-item inventory used to assess physical activity. Each item asks about time spent doing certain activities within the past week. Responses can range from 0 (not at all) to 7 days per week and/or 24 hours per day. Responses are recorded in days per week and hours/minutes per day. Higher numbers of days per week and/or hours/minutes per day indicate higher levels of physical activity.
Measured: Change from baseline (week 0) to post (week 8)
Smoking/Alcohol Behavior
One-item questions regarding smoking alcohol consumption are used to assess smoking behavior and alcohol consumption. The items ask how many drinks per day/week participants consume and how much they smoke per day/week, if at all. Higher numbers indicate a higher frequency of each behavior.
Measured: Change from baseline (week 0) to post (week 8)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Sep 2019
- Study start10 Jul 2019
- Primary completion10 May 2020
- Study completion10 May 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (11)Papers the sponsor has linked to this study.
- Other trials for StillbirthStudies of the same condition, open and under way.
- More trials run by Arizona State UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- 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.
- Masking
- None (open label)
- Enrolment
- 60 participants (actual)
Sponsor and investigators
- Lead sponsor
- Arizona State University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04077476
- Sponsor's protocol ID
- STUDY00010215
- Status last verified
- Jun 2020
- First submitted
- 18 Jun 2019
- Last updated
- 4 Jun 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 21372060Hughes 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.
PubMed 10381705Ellis 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.
PubMed 26810220Mitchell 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.
PubMed 24668767Park 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.
PubMed 25030795Buttner 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.
PubMed 25886805Naslund 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.
PubMed 26744309McAlpine 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.
PubMed 25535016Cacciatore 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.
PubMed 19281517Cavallo 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.
PubMed 23079176Sullivan 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.
PubMed 35167361
Study at a glance
From the registry record, last updated by the sponsor on 4 Jun 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Feasibility of Online Yoga Plus Social Support to Improve Elevated PTS in Mothers Who Have Experienced Stillbirth
- ClinicalTrials.gov ID
- NCT04077476
- Acronym / sponsor ID
- STUDY00010215
- Conditions
- Stillbirth, Post-traumatic Stress Disorder, Anxiety, Depression
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 60 participants (actual)
- Lead sponsor
- Arizona State UniversityUniversity, hospital or other
- Study start
- 10 Jul 2019 (actual)
- Primary completion
- 10 May 2020 (actual)
- Study completion
- 10 May 2020 (actual)
- First posted
- 4 Sep 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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:
- 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.
- 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.
- 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).
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- 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.
| Arm | Type | Receives |
|---|---|---|
| Online Yoga | Active comparator | Behavioral: Online YogaParticipants 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. |
| Online Yoga + Facebook | Experimental | Behavioral: Online Yoga + FacebookIn 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (10 listed)
- 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
Key exclusion criteria (3 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Online Yoga + FacebookEach 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. | Behavioural | Online Yoga + Facebook |
| Online YogaParticipants 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. | Behavioural | Online Yoga |
Primary outcome
Berlin Social Support Scale
Time frame: Change from baseline (week 0) to post (week 8)
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).
Feasibility: satisfaction survey
Time frame: Post (week 8)
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).
Impact of Events Scale-Revised
Time frame: Change from baseline (week 0) to post (week 8)
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).
State-Trait Anxiety Inventory
Time frame: Change from baseline (week 0) to post (week 8)
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).
Patient Health Questionnaire (PHQ-9)
Time frame: Change from baseline (week 0) to post (week 8)
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).
3 secondary outcomes
National Cancer Institute's Multifactor Screener (diet)
Time frame: Change from baseline (week 0) to post (week 8)
International Physical Activity Questionnaire
Time frame: Change from baseline (week 0) to post (week 8)
Smoking/Alcohol Behavior
Time frame: Change from baseline (week 0) to post (week 8)
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Jun 2020.
- Results publication: PubMed 21372060Blackmore 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.
- Results publication: PubMed 10381705Hughes 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.
- Results publication: PubMed 26810220Ellis 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.
- Results publication: PubMed 24668767Mitchell 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.
- Results publication: PubMed 25030795Park 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.
- Results publication: PubMed 25886805Buttner 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.
- Results publication: PubMed 26744309Naslund 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.
- Results publication: PubMed 25535016McAlpine 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.
- Results publication: PubMed 19281517Cacciatore 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.
- Results publication: PubMed 23079176Cavallo 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.
- Derived from this study: PubMed 35167361Sullivan 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Online Yoga + Facebook and Online Yoga in people with Stillbirth and Post-traumatic Stress Disorder, run by Arizona State University at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 10 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 4 Jun 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Berlin Social Support Scale (time frame: Change from baseline (week 0) to post (week 8)). The study lists 5 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04077476, which also lists 11 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 4 Jun 2020.