Ignite Creation Date:
2024-05-06 @ 9:11 AM
Last Modification Date:
2024-10-26 @ 12:11 PM
Study NCT ID:
NCT02925481
Status:
COMPLETED
Last Update Posted:
2019-08-29
First Post:
2016-10-04
Brief Title:
Yoga Online Feasibility to Reduce PTSD
Sponsor:
Arizona State University
Organization:
Arizona State University
Study Overview
Official Title:
Yoga Online Interconception Care to Prevent PTSD Symptoms After Stillbirth
Status:
COMPLETED
Status Verified Date:
2019-08
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
Each year more than 26000 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 andor 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 ie 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 ie anxiety and depression the investigators propose to develop and test the feasibility and acceptability of a home-based online streamed yoga intervention wwwudayacom for bereaved mothers with stillbirth
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 andor 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 ie 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 ie anxiety and depression the investigators propose to develop and test the feasibility and acceptability of a home-based online streamed yoga intervention wwwudayacom for bereaved mothers with stillbirth
Detailed Description:
Phase 1 pre-recruitment
Racialethnic panel
The investigators will recruit a panel of racialethnic minority women African American and Hispanic women who have experienced stillbirth n5 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 racialethnic 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
1 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 eg 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
2 Gather a panel of women who have experienced stillbirth n5 and a panel of women who regularly do yoga n5 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 1-2xweek 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
3 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
For our purposes all classes for the intervention will be screened for applicability by the yoga therapist Participants username and passwords will provide them access to only the yoga videos prescribed participants will not have access to the complete Udaya library of yoga videos Participants will be asked to complete the yoga videos in a specific order which will include specialized preparatory instructions for each class to quell apprehension and further ensure safety
After this process the investigators will finalize the yoga prescription for Phase 2 and will submit any modifications to the IRB before recruitment begins
Phase 2 Enrollment Interested participants will complete an eligibility screener on a Qualtrics link or contact the research team via phone or email Our current screener takes approximately 5-10 mins to complete Research team members will follow a script to respond to interested participants who phone or email and refer them to the eligibility screener Eligible participants will receive an email requesting times to schedule a 15 minute intake call ie explain the study and an email confirmation for the appointment Following the intake appointment eligible participants will receive a Qualtrics link asking them to electronically sign an informed consent and participate in a baseline assessment of self-report measures that will take approximately 20 minutes After this step participants will be randomized to intervention or control group See below Ineligible participants will be notified by phone and offered a discounted Udayacom membership
Randomization The investigators will randomize participants into low dose intervention group LD n30 moderate dose intervention group MD n30 or stretch and tone control group STC n30 after the informed consent and baseline questionnaires have been complete Research personnel will use a computer-generated list of numbers ie randomizerorg Research personnel who assign participants to a group will not be the same as those who download or clean data Additionally group status will be entered separately so that research personnel downloading data will be blinded to treatment assignment Women in LD and MD will be prescribed 60 mins or 150 mins of yoga per wk respectively for 12 wks The STC group will complete a minimum of 60 minswk of stretchingtoning exercises to match LD intervention group
Tracking Participation in the videos for all groups LD MD STC will be tracked class taken time of day length of use etc on the Udayacom website throughout the study Before beginning the study the research team will send each participant a daily log Qualtrics link to self-track a completion of yogastretching sessions b rate of perceived exertion c assessment of mindfulness d other PA participation e participation in psychotherapy ie cognitive behavioral therapy and f pregnancy mental health and use of psychiatric medication see dailyweekly log Research personnel will contact participants weekly via emailtext to remind them to participate in yogastretching and complete dailyweekly logs Participants will be given a choice of text or email reminders If a participant from the intervention or STC is not meeting their minimal dose requirement andor not tracking their sessions research personnel will reach out to the participant via textemail reminder
Control STC The investigators will inform the adaptation of the STC group using Consultant McAuleys well established evidence-based control group originally designed for older adults The investigators will modify the prescription for the control group to be more age and population specific for the proposed study All videos will be produced by Udayacom and taught by a trained exercise professional The STC group will complete a minimum of 60 minswk of stretchingtoning exercises to match the LD intervention group The instructor will ask participants to perform each isolated stretch limbering or toning exercise for 20-30 seconds and repeat five times Participants will be asked to perform slow controlled and complete movements Women will be given 4 upper body 4 lower body 3 trunkcore and 1-2 balance exercises with appropriate progression over 12 wks Retention of women in the control group is important to the internal validity of the study As such the stretch limbering and toning exercises will be combined in different orders within each video to prevent boredom as recommended by Consultant McAuley An important adaptation for the control group is the provision of modifications of each individual exercise For each exercise the instructor will demonstrate a modified version that is slightly less difficult and a more challenging version that adds difficulty for those who have mastered the movement capabilities these modifications will allow the program to be highly adaptable for women with a wide range of capabilities
The STC videos will have discussion related to form and safety by the instructor ie no guidance for movement with breath or mindfulness Additionally videos will have students in the background following instructor cues and demonstrating variations of exercises There will be no final relaxation pose in the STC videos ie the rest period during which the efforts of PA are soothed the mind is most receptive to stillness and the cultivation of mindfulness culminates Usernames and passwords for women in the control group will be specific to accessing only the STC group videos on Udayacom
Pregnancy during Intervention
In the case that a woman becomes pregnant during this study the investigators will ask her to complete the Physical Activity Readiness Medical Examination for Pregnancy PARmed-X for Pregnancy a health-screening tool for participation in prenatal exercise The PARmed-X for pregnancy is completed with their primary care physician to identify any contraindications to exercise and includes 29 questions pertaining to general health status status of current pregnancy physical activity habits over the last month and absolute and relative contraindications
It has been well established that yoga is safe during pregnancy and postpartum and all classes prescribed will be suitable for women up to 20-wks gestation the maximum possible based on our study eligibility At any time during the study if the participants medical team advise her not to participate in yoga or other exercise she would be immediately withdrawn from the study Pregnancy status will be tracked throughout the 12-week study period via weekly assessment in weekly logs
Post-intervention
Post-intervention questionnaires will be administered via web-based survey ie Qualtrics at the end of week 12 In addition follow-up surveys will be administered via web-based survey ie Qualtrics at 20-wks post baseline assessments
Qualitative interviews following best practices for conducting interviews will be conducted with 15 participants The qualitative interviews will be used to supplement information gained from the satisfaction surveys and to further understand the use of non-pharmacological interventions such as yoga in this population Purposive sampling strategies ie maximum variation sampling will be used to understand individuals experiences and inform the future larger trial The investigators will specifically select participants from the study approximately 5 from each intervention group and 5 from control group or until data saturation has been reached that represent those who had highlow compliance at least 3 of 5 will be those who had low compliance ie not reaching their prescribed minimal dose of yoga and at least 3 of 5 will be racialethnic minorities Qualitative interviews will be administered in the intervention groups at post-intervention 12 wks and at follow-up 20 wks and will last approximately 15-20 minutes
Racialethnic panel
The investigators will recruit a panel of racialethnic minority women African American and Hispanic women who have experienced stillbirth n5 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 racialethnic 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
1 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 eg 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
2 Gather a panel of women who have experienced stillbirth n5 and a panel of women who regularly do yoga n5 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 1-2xweek 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
3 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
For our purposes all classes for the intervention will be screened for applicability by the yoga therapist Participants username and passwords will provide them access to only the yoga videos prescribed participants will not have access to the complete Udaya library of yoga videos Participants will be asked to complete the yoga videos in a specific order which will include specialized preparatory instructions for each class to quell apprehension and further ensure safety
After this process the investigators will finalize the yoga prescription for Phase 2 and will submit any modifications to the IRB before recruitment begins
Phase 2 Enrollment Interested participants will complete an eligibility screener on a Qualtrics link or contact the research team via phone or email Our current screener takes approximately 5-10 mins to complete Research team members will follow a script to respond to interested participants who phone or email and refer them to the eligibility screener Eligible participants will receive an email requesting times to schedule a 15 minute intake call ie explain the study and an email confirmation for the appointment Following the intake appointment eligible participants will receive a Qualtrics link asking them to electronically sign an informed consent and participate in a baseline assessment of self-report measures that will take approximately 20 minutes After this step participants will be randomized to intervention or control group See below Ineligible participants will be notified by phone and offered a discounted Udayacom membership
Randomization The investigators will randomize participants into low dose intervention group LD n30 moderate dose intervention group MD n30 or stretch and tone control group STC n30 after the informed consent and baseline questionnaires have been complete Research personnel will use a computer-generated list of numbers ie randomizerorg Research personnel who assign participants to a group will not be the same as those who download or clean data Additionally group status will be entered separately so that research personnel downloading data will be blinded to treatment assignment Women in LD and MD will be prescribed 60 mins or 150 mins of yoga per wk respectively for 12 wks The STC group will complete a minimum of 60 minswk of stretchingtoning exercises to match LD intervention group
Tracking Participation in the videos for all groups LD MD STC will be tracked class taken time of day length of use etc on the Udayacom website throughout the study Before beginning the study the research team will send each participant a daily log Qualtrics link to self-track a completion of yogastretching sessions b rate of perceived exertion c assessment of mindfulness d other PA participation e participation in psychotherapy ie cognitive behavioral therapy and f pregnancy mental health and use of psychiatric medication see dailyweekly log Research personnel will contact participants weekly via emailtext to remind them to participate in yogastretching and complete dailyweekly logs Participants will be given a choice of text or email reminders If a participant from the intervention or STC is not meeting their minimal dose requirement andor not tracking their sessions research personnel will reach out to the participant via textemail reminder
Control STC The investigators will inform the adaptation of the STC group using Consultant McAuleys well established evidence-based control group originally designed for older adults The investigators will modify the prescription for the control group to be more age and population specific for the proposed study All videos will be produced by Udayacom and taught by a trained exercise professional The STC group will complete a minimum of 60 minswk of stretchingtoning exercises to match the LD intervention group The instructor will ask participants to perform each isolated stretch limbering or toning exercise for 20-30 seconds and repeat five times Participants will be asked to perform slow controlled and complete movements Women will be given 4 upper body 4 lower body 3 trunkcore and 1-2 balance exercises with appropriate progression over 12 wks Retention of women in the control group is important to the internal validity of the study As such the stretch limbering and toning exercises will be combined in different orders within each video to prevent boredom as recommended by Consultant McAuley An important adaptation for the control group is the provision of modifications of each individual exercise For each exercise the instructor will demonstrate a modified version that is slightly less difficult and a more challenging version that adds difficulty for those who have mastered the movement capabilities these modifications will allow the program to be highly adaptable for women with a wide range of capabilities
The STC videos will have discussion related to form and safety by the instructor ie no guidance for movement with breath or mindfulness Additionally videos will have students in the background following instructor cues and demonstrating variations of exercises There will be no final relaxation pose in the STC videos ie the rest period during which the efforts of PA are soothed the mind is most receptive to stillness and the cultivation of mindfulness culminates Usernames and passwords for women in the control group will be specific to accessing only the STC group videos on Udayacom
Pregnancy during Intervention
In the case that a woman becomes pregnant during this study the investigators will ask her to complete the Physical Activity Readiness Medical Examination for Pregnancy PARmed-X for Pregnancy a health-screening tool for participation in prenatal exercise The PARmed-X for pregnancy is completed with their primary care physician to identify any contraindications to exercise and includes 29 questions pertaining to general health status status of current pregnancy physical activity habits over the last month and absolute and relative contraindications
It has been well established that yoga is safe during pregnancy and postpartum and all classes prescribed will be suitable for women up to 20-wks gestation the maximum possible based on our study eligibility At any time during the study if the participants medical team advise her not to participate in yoga or other exercise she would be immediately withdrawn from the study Pregnancy status will be tracked throughout the 12-week study period via weekly assessment in weekly logs
Post-intervention
Post-intervention questionnaires will be administered via web-based survey ie Qualtrics at the end of week 12 In addition follow-up surveys will be administered via web-based survey ie Qualtrics at 20-wks post baseline assessments
Qualitative interviews following best practices for conducting interviews will be conducted with 15 participants The qualitative interviews will be used to supplement information gained from the satisfaction surveys and to further understand the use of non-pharmacological interventions such as yoga in this population Purposive sampling strategies ie maximum variation sampling will be used to understand individuals experiences and inform the future larger trial The investigators will specifically select participants from the study approximately 5 from each intervention group and 5 from control group or until data saturation has been reached that represent those who had highlow compliance at least 3 of 5 will be those who had low compliance ie not reaching their prescribed minimal dose of yoga and at least 3 of 5 will be racialethnic minorities Qualitative interviews will be administered in the intervention groups at post-intervention 12 wks and at follow-up 20 wks and will last approximately 15-20 minutes
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| R34AT008808 | NIH | None | httpsreporternihgovquickSearchR34AT008808 |