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Feasibility of Online Yoga With Facebook After Stillbirth

2020년 6월 2일 업데이트: Arizona State University

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.

연구 개요

상세 설명

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:

  1. 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.
  2. 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.
  3. 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).

연구 유형

중재적

등록 (실제)

60

단계

  • 해당 없음

연락처 및 위치

이 섹션에서는 연구를 수행하는 사람들의 연락처 정보와 이 연구가 수행되는 장소에 대한 정보를 제공합니다.

연구 장소

    • Arizona
      • Phoenix, Arizona, 미국, 85004
        • Arizona Biomedical Collaborative

참여기준

연구원은 적격성 기준이라는 특정 설명에 맞는 사람을 찾습니다. 이러한 기준의 몇 가지 예는 개인의 일반적인 건강 상태 또는 이전 치료입니다.

자격 기준

공부할 수 있는 나이

18년 이상 (성인, 고령자)

건강한 자원 봉사자를 받아들입니다

연구 대상 성별

여성

설명

Inclusion Criteria:

  • Women
  • Ages 18+
  • Had a stillbirth within the past 3 years
  • Can safely participate in exercise as determined by the Physical Activity Readiness Questionnaire (PAR-Q): Answer "no" to all items on PAR-Q (can participate safely)
  • Not currently practicing yoga: Operationally defined as participating ≥60 minutes per week within the past 6 months
  • Have symptoms of PTSD (>24 on the Impact of Events Scale-Revised (IES-R), which is classified as "PTSD is a clinical concern."
  • Not pregnant at the time of the intervention
  • Have, or be willing to create, a Facebook account
  • Willing to be randomized
  • Able to read and understand English

Exclusion Criteria:

  • 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

공부 계획

이 섹션에서는 연구 설계 방법과 연구가 측정하는 내용을 포함하여 연구 계획에 대한 세부 정보를 제공합니다.

연구는 어떻게 설계됩니까?

디자인 세부사항

  • 주 목적: 치료
  • 할당: 무작위
  • 중재 모델: 병렬 할당
  • 마스킹: 없음(오픈 라벨)

무기와 개입

참가자 그룹 / 팔
개입 / 치료
활성 비교기: Online Yoga
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.
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.
실험적: Online Yoga + Facebook
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.
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.

연구는 무엇을 측정합니까?

주요 결과 측정

결과 측정
측정값 설명
기간
Berlin Social Support Scale
기간: 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).
Change from baseline (week 0) to post (week 8)
Feasibility: satisfaction survey
기간: 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).
Post (week 8)
Impact of Events Scale-Revised
기간: 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).
Change from baseline (week 0) to post (week 8)
State-Trait Anxiety Inventory
기간: 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).
Change from baseline (week 0) to post (week 8)
Patient Health Questionnaire (PHQ-9)
기간: 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).
Change from baseline (week 0) to post (week 8)

2차 결과 측정

결과 측정
측정값 설명
기간
National Cancer Institute's Multifactor Screener (diet)
기간: Change from baseline (week 0) to post (week 8)
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.
Change from baseline (week 0) to post (week 8)
International Physical Activity Questionnaire
기간: Change from baseline (week 0) to post (week 8)
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.
Change from baseline (week 0) to post (week 8)
Smoking/Alcohol Behavior
기간: Change from baseline (week 0) to post (week 8)
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.
Change from baseline (week 0) to post (week 8)

공동 작업자 및 조사자

여기에서 이 연구와 관련된 사람과 조직을 찾을 수 있습니다.

간행물 및 유용한 링크

연구에 대한 정보 입력을 담당하는 사람이 자발적으로 이러한 간행물을 제공합니다. 이것은 연구와 관련된 모든 것에 관한 것일 수 있습니다.

일반 간행물

연구 기록 날짜

이 날짜는 ClinicalTrials.gov에 대한 연구 기록 및 요약 결과 제출의 진행 상황을 추적합니다. 연구 기록 및 보고된 결과는 공개 웹사이트에 게시되기 전에 특정 품질 관리 기준을 충족하는지 확인하기 위해 국립 의학 도서관(NLM)에서 검토합니다.

연구 주요 날짜

연구 시작 (실제)

2019년 7월 10일

기본 완료 (실제)

2020년 5월 10일

연구 완료 (실제)

2020년 5월 10일

연구 등록 날짜

최초 제출

2019년 6월 18일

QC 기준을 충족하는 최초 제출

2019년 8월 30일

처음 게시됨 (실제)

2019년 9월 4일

연구 기록 업데이트

마지막 업데이트 게시됨 (실제)

2020년 6월 4일

QC 기준을 충족하는 마지막 업데이트 제출

2020년 6월 2일

마지막으로 확인됨

2020년 6월 1일

추가 정보

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이 정보는 변경 없이 clinicaltrials.gov 웹사이트에서 직접 가져온 것입니다. 귀하의 연구 세부 정보를 변경, 제거 또는 업데이트하도록 요청하는 경우 register@clinicaltrials.gov. 문의하십시오. 변경 사항이 clinicaltrials.gov에 구현되는 즉시 저희 웹사이트에도 자동으로 업데이트됩니다. .

Online Yoga에 대한 임상 시험

구독하다