Yoga Online Feasibility to Reduce PTSD
| Status: | Recruiting |
|---|---|
| Conditions: | Psychiatric |
| Therapuetic Areas: | Psychiatry / Psychology |
| Healthy: | No |
| Age Range: | 18 - Any |
| Updated: | 6/29/2018 |
| Start Date: | April 2016 |
| End Date: | June 2019 |
| Contact: | Jennifer Huberty, PhD |
| Email: | Jennifer.Huberty@asu.edu |
| Phone: | 602.827.2456 |
Yoga Online: Interconception Care to Prevent PTSD Symptoms After Stillbirth
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.
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.
Phase 1 (pre-recruitment):
Racial/ethnic panel:
The investigators will recruit a panel of racial/ethnic minority women (African American and
Hispanic women) who have experienced stillbirth (n=5) 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 racial/ethnic 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) (e.g., 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 (n=5) and a panel of women who
regularly do yoga (n=5) 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 (1-2x/week).
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 (i.e., 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 Udaya.com membership.
Randomization: The investigators will randomize participants into low dose intervention group
(LD; n=30), moderate dose intervention group (MD; n=30), or stretch and tone control group
(STC; n=30) after the informed consent and baseline questionnaires have been complete.
Research personnel will use a computer-generated list of numbers (i.e., randomizer.org).
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 mins/wk of stretching/toning 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 Udaya.com 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 yoga/stretching sessions; (b) rate of perceived exertion;
(c) assessment of mindfulness; (d) other PA participation; (e) participation in psychotherapy
(i.e., cognitive behavioral therapy); and (f) pregnancy, mental health, and use of
psychiatric medication (see daily/weekly log). Research personnel will contact participants
weekly (via email/text) to remind them to participate in yoga/stretching and complete
daily/weekly 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 and/or
not tracking their sessions, research personnel will reach out to the participant via
text/email reminder.
Control (STC). The investigators will inform the adaptation of the STC group using Consultant
McAuley's 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 Udaya.com and
taught by a trained exercise professional. The STC group will complete a minimum of 60
mins/wk of stretching/toning 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 trunk/core, 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 (i.e., 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 (i.e., 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 Udaya.com.
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 participant's 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 (i.e., Qualtrics)
at the end of week 12. In addition, follow-up surveys will be administered via web-based
survey (i.e., 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 (i.e., 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 high/low compliance (at least 3 of
5 will be those who had low compliance (i.e., not reaching their prescribed minimal dose of
yoga) and at least 3 of 5 will be racial/ethnic 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.
Racial/ethnic panel:
The investigators will recruit a panel of racial/ethnic minority women (African American and
Hispanic women) who have experienced stillbirth (n=5) 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 racial/ethnic 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) (e.g., 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 (n=5) and a panel of women who
regularly do yoga (n=5) 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 (1-2x/week).
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 (i.e., 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 Udaya.com membership.
Randomization: The investigators will randomize participants into low dose intervention group
(LD; n=30), moderate dose intervention group (MD; n=30), or stretch and tone control group
(STC; n=30) after the informed consent and baseline questionnaires have been complete.
Research personnel will use a computer-generated list of numbers (i.e., randomizer.org).
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 mins/wk of stretching/toning 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 Udaya.com 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 yoga/stretching sessions; (b) rate of perceived exertion;
(c) assessment of mindfulness; (d) other PA participation; (e) participation in psychotherapy
(i.e., cognitive behavioral therapy); and (f) pregnancy, mental health, and use of
psychiatric medication (see daily/weekly log). Research personnel will contact participants
weekly (via email/text) to remind them to participate in yoga/stretching and complete
daily/weekly 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 and/or
not tracking their sessions, research personnel will reach out to the participant via
text/email reminder.
Control (STC). The investigators will inform the adaptation of the STC group using Consultant
McAuley's 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 Udaya.com and
taught by a trained exercise professional. The STC group will complete a minimum of 60
mins/wk of stretching/toning 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 trunk/core, 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 (i.e., 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 (i.e., 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 Udaya.com.
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 participant's 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 (i.e., Qualtrics)
at the end of week 12. In addition, follow-up surveys will be administered via web-based
survey (i.e., 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 (i.e., 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 high/low compliance (at least 3 of
5 will be those who had low compliance (i.e., not reaching their prescribed minimal dose of
yoga) and at least 3 of 5 will be racial/ethnic 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.
Inclusion Criteria:
1. Women who experienced stillbirth (>20 wks gestation) within past 24 mos
2. Clinical levels posttraumatic stress symptoms (>33 as measured by the IES-R)
3. ≥ 18 yrs of age
4. Residing in U.S.
5. Able to read/understand English
6. Underactive (≤120 mins/wk moderate intensity PA)
7. Willing to be randomized
8. 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.
Exclusion Criteria:
1. Unstable psychiatric condition (psychosis; suicidal ideation with plan)
2. Pregnant at time of enrollment
3. Practicing yoga at least 60 mins/wk
4. Unwilling to be randomized to a group.
5. At risk for suicide based on follow-up phone assessment by a trained contact person
under supervision of Dr. Cacciatore after positive screen
6. (PHQ-9 score of 1, 2, or 3)
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