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Trial record 1 of 1 for:    NCT02925481
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Yoga Online Feasibility to Reduce PTSD

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ClinicalTrials.gov Identifier: NCT02925481
Recruitment Status : Completed
First Posted : October 6, 2016
Last Update Posted : August 29, 2019
Sponsor:
Collaborators:
National Institutes of Health (NIH)
National Center for Complementary and Integrative Health (NCCIH)
Information provided by (Responsible Party):
Jennifer Huberty, Arizona State University

Brief Summary:

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.


Condition or disease Intervention/treatment Phase
PTSD Behavioral: Moderate Online yoga participation Behavioral: Stretching and toning Behavioral: Low dose online yoga participation Not Applicable

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 90 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Participant)
Primary Purpose: Treatment
Official Title: Yoga Online: Interconception Care to Prevent PTSD Symptoms After Stillbirth
Study Start Date : April 2016
Actual Primary Completion Date : June 2019
Actual Study Completion Date : June 2019

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Stillbirth

Arm Intervention/treatment
Experimental: Low dose Yoga
12 week online yoga for 60 minutes per week
Behavioral: Low dose online yoga participation
Phase 1: Testing yoga videos for emotional regulation and self-compassion which will inform the selected videos for Phase 2 prescription Phase 2: 60 minutes of Online streaming yoga videos completed at home. Week 1/2 introductory videos that include short video clips breaking down each pose Weeks 3-12 increase in difficulty (all videos are appropriate for beginners)
Other Name: LD

Experimental: Moderate dose Yoga
12 week online yoga for 150 minutes per week
Behavioral: Moderate Online yoga participation
Phase 1: Testing yoga videos for emotional regulation and self-compassion which will inform the selected videos for Phase 2 prescription Phase 2: 150 minutes of Online streaming yoga videos completed at home. Week 1/2 introductory videos that include short video clips breaking down each pose Weeks 3-12 increase in difficulty (all videos are appropriate for beginners)
Other Name: MD

Active Comparator: Stretch and toning
12 week online stretching, toning exercises for 60 minutes per week
Behavioral: Stretching and toning
Phase 1: Developing 12 week prescription for online control videos Phase 2: Online streaming stretching and toning videos completed at home which consist of a warm-up, 1 balance, 2 core, 2-3 upper body and lower body exercises, 6 stretches, cool-down
Other Name: STC




Primary Outcome Measures :
  1. Clinically elevated levels of PTSD (according to IES-R) [ Time Frame: 12 weeks ]

Secondary Outcome Measures :
  1. Impact of Events Survey (IES-R) [ Time Frame: 12 weeks post baseline ]
    Post-traumatic stress disorder symptoms were measured using the Impact of Events Scale (IES-R). The IES-R was developed to reflect the criteria for PTSD per the Diagnostic Symptom Manual (DSM-IV). There scale consists of 22 questions which are scored on a five-point Likert scale (0=not at all, 1=a little bit, 2=moderately, 3=quite a bit, 4=extremely). There are three subscales (i.e., avoidance, intrusion, hyperarousal) and the sub of the three subscales scores comprise the total score. A total score ≥33 indicates the likely presence of PTSD.

  2. State-Trait Anxiety Inventory [ Time Frame: 12 weeks post baseline ]
    The State-Trait Anxiety Inventory (STAI) yields scores indicating levels of train (Form Y-1) and state (Form Y-2) anxiety, with higher scores indicating greater levels of anxiety. This scale is scored using a four-point Likert scale(1=not at all, 2=somewhat, 3=moderately so, 4=very much so), and participants respond to questions such as, "I feel calm," and "I feel nervous and restless." The STAI has demonstrated reliability in pregnant and postpartum populations.

  3. Patient Health Questionnaire (PHQ-9) [ Time Frame: 12 weeks post baseline ]
    The Patient Health Questionnaire-9 (PHQ-9) was used to measure depressive symptoms. This measure is commonly used to screen, diagnose, monitor, and measure the severity of depression, Scores range from 0-27 and cut-off scores of 5, 10, 15, and 20 indicate mild, moderate, moderately severe, and severe depressive symptoms, respectively. This scale is valid and reliable in general populations (α=.86-.89) and has been validated in pregnant and postpartum populations.

  4. Perinatal Grief Scale (PGS) [ Time Frame: 12 weeks post baseline ]
    The Perinatal Grief Scale (PGS) is a valid 33-item instrument used to quantify the grief of perinatal loss. This scale consists of three subscales (active grief, difficulty coping, and despair) and uses a 5-point Likert scale (1=strongly agree to 5=disagree). The three subscales have a possible range of 11-55, and higher scores indicate more intense grief.

  5. Self-Compassion Scale [ Time Frame: 12 weeks post baseline ]
    The Self-Compassion Scale (SCS) is a 26-item questionnaire using a five-point Likert scale from 1=almost never to 5=almost always, The SCS consists of six subscales (self-kindness, self-judgment, common humanity, isolation, mindfulness, over-identified) and has good construct validity and reliability (α=.92). A total score is calculated by taking the mean of each subscale and reverse scoring the negative subscale items (i.e., self-judgment, isolation, over-identification) and computing a total mean. Higher scores indicate higher levels of self-compassion. A sample question includes, "When times are really difficult, I tend to be tough on myself."

  6. Emotional Regulation Questionnaire (ERQ) [ Time Frame: 12 weeks post baseline ]
    The Emotion Regulation Questionnaire (ERQ) is a 10-item scale used to measure an individual's tendency to regulate his or her emotions by two strategies: cognitive reappraisal and expressive suppression. Higher scores indicate greater use of emotional regulation strategies.

  7. Pittsburgh Sleep Quality Index [ Time Frame: 12 weeks post baseline ]
    Sleep was measured subjectively using the Pittsburgh Sleep Quality Index (PSQI). The PSQI is a 19-item questionnaire that has demonstrated reliability and validity in pregnant populations. Higher global PSQI scores indicate more sleep disturbances. We also measured sleep using objective measures.

  8. Modifiable Activity Questionnaire (MAQ) [ Time Frame: 12 weeks post baseline ]
    The Modifiable Activity Questionnaire (MAQ) is a self-report scale used to assess frequency and duration of various activities. It was designed to be modified to assess physical activity in different populations.

  9. SF-12v2 Health Survey (SF-12) [ Time Frame: 12 weeks post baseline ]
    The SF-12 is a 12-item scale assessing self-reported health. The scale was developed for and widely used in the general population. It is comprised of subscales with physical and mental health domains. The physical and mental composite sub-scores are scored on a scale from 0 (lowest level of health) to 100 (highest level of health).

  10. Mindfulness Attention Awareness Scale (MAAS) [ Time Frame: 12 weeks post baseline ]
    The Mindful Attention Awareness Scale (MAAS) is a 15-item scale that measures the extent to which individuals are able to maintain awareness of present-moment experience. This scale uses a 6-point Likert scale (ranging from 1=almost always to 6=almost never), and the mean is computed to generate a total score. Higher scores indicate higher levels of mindfulness.



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

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)

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02925481


Locations
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United States, Arizona
Arizona Biomedical Collaborative
Phoenix, Arizona, United States, 85004
Sponsors and Collaborators
Arizona State University
National Institutes of Health (NIH)
National Center for Complementary and Integrative Health (NCCIH)
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: Jennifer Huberty, Associate Professor in the School of Nutrition and Health Promotion, Arizona State University
ClinicalTrials.gov Identifier: NCT02925481    
Other Study ID Numbers: R34AT008808 ( U.S. NIH Grant/Contract )
R34AT008808 ( U.S. NIH Grant/Contract )
First Posted: October 6, 2016    Key Record Dates
Last Update Posted: August 29, 2019
Last Verified: August 2019
Keywords provided by Jennifer Huberty, Arizona State University:
Yoga
PTSD
mental health
stillbirth
Additional relevant MeSH terms:
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Stillbirth
Fetal Death
Pregnancy Complications
Death
Pathologic Processes