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A study protocol of a three-group randomized feasibility trial of an online yoga intervention for mothers after stillbirth (The Mindful Health Study).

ABSTRACT: BACKGROUND:In the USA, stillbirth (in utero fetal death ?20 weeks gestation) is a major public health issue. Women who experience stillbirth, compared to women with live birth, have a nearly sevenfold increased risk of a positive screen for post-traumatic stress disorder (PTSD) and a fourfold increased risk of depressive symptoms. Because the majority of women who have experienced the death of their baby become pregnant within 12-18 months and the lack of intervention studies conducted within this population, novel approaches targeting physical and mental health, specific to the needs of this population, are critical. Evidence suggests that yoga is efficacious, safe, acceptable, and cost-effective for improving mental health in a variety of populations, including pregnant and postpartum women. To date, there are no known studies examining online-streaming yoga as a strategy to help mothers cope with PTSD symptoms after stillbirth. METHODS:The present study is a two-phase randomized controlled trial. Phase 1 will involve (1) an iterative design process to develop the online yoga prescription for phase 2 and (2) qualitative interviews to identify cultural barriers to recruitment in non-Caucasian women (i.e., predominately Hispanic and/or African American) who have experienced stillbirth (N?=?5). Phase 2 is a three-group randomized feasibility trial with assessments at baseline, and at 12 and 20 weeks post-intervention. Ninety women who have experienced a stillbirth within 6 weeks to 24 months will be randomized into one of the following three arms for 12 weeks: (1) intervention low dose (LD) = 60 min/week online-streaming yoga (n?=?30), (2) intervention moderate dose (MD) = 150 min/week online-streaming yoga (n?=?30), or (3) stretch and tone control (STC) group = 60 min/week of stretching/toning exercises (n?=?30). DISCUSSION:This study will explore the feasibility and acceptability of a 12-week, home-based, online-streamed yoga intervention, with varying doses among mothers after a stillbirth. If feasible, the findings from this study will inform a full-scale trial to determine the effectiveness of home-based online-streamed yoga to improve PTSD. Long-term, health care providers could use online yoga as a non-pharmaceutical, inexpensive resource for stillbirth aftercare. TRIAL REGISTRATION:NCT02925481.

SUBMITTER: Huberty J

PROVIDER: S-EPMC5501104 | biostudies-literature | 2018

REPOSITORIES: biostudies-literature

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A study protocol of a three-group randomized feasibility trial of an online yoga intervention for mothers after stillbirth (The Mindful Health Study).

Huberty Jennifer J Matthews Jeni J Leiferman Jenn J Cacciatore Joanne J Gold Katherine J KJ

Pilot and feasibility studies 20170706

<h4>Background</h4>In the USA, stillbirth (in utero fetal death ≥20 weeks gestation) is a major public health issue. Women who experience stillbirth, compared to women with live birth, have a nearly sevenfold increased risk of a positive screen for post-traumatic stress disorder (PTSD) and a fourfold increased risk of depressive symptoms. Because the majority of women who have experienced the death of their baby become pregnant within 12-18 months and the lack of intervention studies conducted w ...[more]

PMID: 28694991

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Project description:Background:About 1 in every 150 pregnancies end in stillbirth. Consequences include symptoms of post traumatic stress disorder (PTSD), depression, and anxiety. Yoga has been used to treat PTSD in other populations and may improve health outcomes for stillbirth mothers. The purpose of this study was to determine: (a) feasibility of a 12-week home-based, online yoga intervention with varying doses; (b) acceptability of a "stretch and tone" control group; and (c) preliminary efficacy of the intervention on reducing symptoms of PTSD, anxiety, depression, perinatal grief, self-compassion, emotional regulation, mindfulness, sleep quality, and subjective health.Methods:Participants (N = 90) were recruited nationally and randomized into one of three groups for yoga or exercise (low dose (LD), 60 min per week; moderate dose (MD), 150 min per week; and stretch-and-tone control group (STC)). Baseline and post-intervention surveys measured main outcomes (listed above). Frequency analyses were used to determine feasibility. Repeated measures ANCOVA were used to determine preliminary efficacy. Multiple regression analyses were used to determine a dose-response relationship between minutes of yoga and each outcome variable.Results:Over half of participants completed the intervention (n = 48/90). Benchmarks (≥70% reported > 75% satisfaction) were met in each group for satisfaction and enjoyment. Participants meeting benchmarks (completing > 90% of prescribed minutes 9/12 weeks) for LD and MD groups were 44% (n = 8/18) and 6% (n = 1/16), respectively. LD and MD groups averaged 44.0 and 77.3 min per week of yoga, respectively. The MD group reported that 150 prescribed minutes per week of yoga was too much. There were significant decreases in PTSD and depression, and improvements in self-rated health at post-intervention for both intervention groups. There was a significant difference in depression scores (p = .036) and grief intensity (p = .009) between the MD and STC groups. PTSD showed non-significant decreases of 43% and 56% at post-intervention in LD and MD groups, respectively (22% decrease in control).Conclusions:This was the first study to determine the feasibility and preliminary efficacy of an online yoga intervention for women after stillbirth. Future research warrants a randomized controlled trial.Trial registration:ClinicalTrials.gov. NCT02925481. Registered 10-04-16.

Project description:BackgroundNonpharmacological and accessible therapies that engage individuals in self-management are needed to address depressive symptoms in pregnancy. The 12-week "Mindful Moms" intervention was designed to empower pregnant women with depressive symptomatology to create personal goals and engage in mindful physical activity using prenatal yoga.ObjectivesThis longitudinal pilot study evaluated the feasibility, acceptability, and preliminary effects of the "Mindful Moms" intervention in pregnant women with depressive symptoms.MethodsWe evaluated enrollment and retention data (feasibility) and conducted semistructured interviews (acceptability). We evaluated the intervention's effects over time on participants' depressive symptoms, anxiety, perceived stress, self-efficacy, and maternal-child attachment, and we compared findings to an archival comparison group, also assessed longitudinally.ResultsEnrollment and retention rates and positive feedback from participants support the intervention's acceptability and feasibility. "Mindful Moms" participants experienced decreases in depressive symptoms, perceived stress, anxiety, ruminations, and maternal-child attachment and no change in physical activity self-efficacy from baseline to postintervention. Comparisons of the "Mindful Moms" intervention to the comparison groups over time indicated differences in depressive symptoms between all groups and a trend in differences in perceived stress.DiscussionResults support the feasibility and acceptability of "Mindful Moms" for pregnant women with depressive symptoms and suggest that further research is warranted to evaluate this intervention for reducing depressive and related symptoms. Lack of a concurrent control group, with equivalent attention from study staff, and no randomization limit the generalizability of this study; yet, these preliminary findings support future large-scale randomized controlled trials to further evaluate this promising intervention.

Project description:BackgroundPostpartum depression (PPD) has a 20% 3-month prevalence rate. The consequences of PPD are significant for the mother, infant, and the family. There is a need for preventive interventions for PPD, which are effective and accessible; however, many barriers exist for women who attempt to access perinatal depression prevention programs. Internet interventions for the treatment and prevention of depression are widely accepted as efficacious and may overcome some of the issues pertaining to access to treatment barriers perinatal women face. However, internet interventions offered without any human support tend to have low adherence but positive outcomes for those who do complete treatment. Internet support groups often have high levels of adherence but minimal data supporting efficacy as a treatment for depression. Taken together, these findings suggest that combining the treatment components of individual interventions with the support provided by an internet support group might create an intervention with the scalability and cost-effectiveness of an individual intervention and the better outcomes typically found in supported interventions.ObjectivesThis study aimed to describe the development of a cognitive behavioral therapy (CBT) internet intervention with peer support to prevent PPD and examine preliminary depression and site usage outcomes.MethodsUser-centered design groups were used to develop the internet intervention. Once the intervention was developed, women who were 20 to 28 weeks pregnant with symptoms of depression (Patient Health Questionnaire-8 scores of 5-14) but who had no major depression diagnosis were enrolled in a randomized controlled trial (RCT) to compare 8 weeks of a CBT-based internet intervention with peer support to an individual internet intervention designed to prevent PPD. Assessments took place at baseline, 4 weeks, 8 weeks (end of treatment), and then 4 weeks and 6 weeks postpartum.ResultsA total of 25 women were randomized. Of these, 24 women completed the RCT. Patient Health Questionnaire-9 scores at 6 weeks postpartum remained below the clinical threshold for referral for treatment in both groups, with depression measures showing a decrease in symptoms from baseline to postpartum. At 6 weeks postpartum, only 4% (1/24) met the criteria for PPD. There was no difference between groups in adherence to the intervention, with an average of 14.55 log-ins over the course of treatment.ConclusionsResults suggest women were responsive to both peer support and individual internet interventions to prevent PPD and that peer support may be a useful feature to keep participants adherent.Trial registrationClinicalTrials.gov NCT02121015; https://clinicaltrials.gov/ct2/show/NCT02121015 (archived by WebCite at http://www.webcitation.org/765a7qBKy).

Project description:BackgroundThe Zika virus outbreak in Brazil (2015-2016) affected thousands of children who were born with Congenital Zika Syndrome (CZS). Families play an important role in their care of children with complex needs, yet their knowledge, experience and skills are rarely harnessed in existing interventions to best support these families.ObjectiveThis study explores the use of mothers as facilitators for a community-based group intervention for children with CZS and their caregivers in Brazil.MethodsFour facilitators were trained to deliver the 10-week intervention called "Juntos". Two were mothers of a child with CZS ("expert mothers") and two were therapists (speech therapist and physiotherapist). The intervention was delivered to three groups, generally including 8-10 caregivers. Two researchers, who were psychologists, observed the groups and held focus group discussions at the end of each session. They undertook semi-structured interviews post intervention with a purposive sample of caregivers, and with the facilitators. Observation notes were collated and summarised. Transcripts were transcribed and thematically analysed using five elements to assess feasibility: acceptability, demand, implementation, practicality and adaptation.ResultsThe use of expert mothers as facilitators was considered to be acceptable and there was demand for their role. Their experiential knowledge was viewed as important for sharing and learning, and supporting and encouraging the group. The intervention was delivered with fidelity by the expert mothers. The practicality of the intervention was facilitated by holding the group sessions in the community, providing transport costs to facilitators and participants, paying expert mothers and therapist facilitators equally and supporting the expert mothers through a mentorship programme. Equal payment with the therapist enabled the expert mothers to better facilitate the groups, through increased confidence in the value of their role. Adaptation of the intervention included development of video resources and mentoring guidelines.ConclusionThe use of expert mothers as facilitators of caregiver groups provides a unique approach to harness the knowledge, experience, and skills of families to provide care, and is likely to be feasible in similar contexts.

Project description:BackgroundA significant proportion of older women suffer from chronic pain, which can decrease quality of life. The objective of this pilot randomized study was to evaluate the feasibility of a flow-restorative yoga intervention designed to decrease pain and related outcomes among women aged 60 or older.MethodsFlow-restorative yoga classes were held twice weekly for 1 hour and led by a certified yoga instructor. Participants randomized to the intervention group attended the yoga classes for 12 weeks and received supplemental materials for at-home practice. Those randomized to the control group were asked to maintain their normal daily routine. Feasibility was evaluated using recruitment and retention rates, class and home practice adherence rates, and participant satisfaction surveys. Outcome measures (self-reported pain, inflammatory markers, functional fitness, quality of life, resilience, and self-reported physical activity) were assessed at baseline and post-intervention. Paired t-tests or Wilcoxon signed-rank tests were used to examine changes in outcome measures within treatment groups.ResultsThirty-eight participants were recruited and randomized. Participants were primarily white, college-educated, and higher functioning, despite experiencing various forms of chronic pain. Attendance and retention rates were high (91 and 97%, respectively) and the majority of participants were satisfied with the yoga program (89%) and would recommend it to others (87%). Intervention participants also experienced reductions in pain interference and improvements in energy and social functioning.ConclusionsThis pilot study provides essential data to inform a full scale randomized trial of flow-restorative yoga for older women with chronic pain. Future studies should emphasize strategies to recruit a more diverse study population, particularly older women at higher risk of disability and functional decline.Trial registrationClinicaltrials.gov , NCT03790098 . Registered 31 December 2018 - Retrospectively registered.

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A study protocol of a three-group randomized feasibility trial of an online yoga intervention for mothers after stillbirth (The Mindful Health Study).

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A study protocol of a three-group randomized feasibility trial of an online yoga intervention for mothers after stillbirth (The Mindful Health Study).

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