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Effects of prenatal mindfulness-based childbirth education on child-bearers' trajectories of distress: a randomized control trial.

ABSTRACT: BACKGROUND:The perinatal period is a time of immense change, which can be a period of stress and vulnerability for mental health difficulties. Mindfulness-based interventions have shown promise for reducing distress, but further research is needed to identify long-term effects and moderators of mindfulness training in the perinatal period. METHODS:The current study used data from a pilot randomized control trial (RCT) comparing a condensed mindfulness-based childbirth preparation program-the Mind in Labor (MIL)-to treatment as usual (TAU) to examine whether prenatal mindfulness training results in lower distress across the perinatal period, and whether the degree of benefit depends on child-bearers' initial levels of risk (i.e., depression and anxiety symptoms) and protective (i.e., mindfulness) characteristics. Child-bearers (N?=?30) in their third trimester were randomized to MIL or TAU and completed assessments of distress-perceived stress, anxiety, and depressive symptoms-at pre-intervention, post-intervention, six-weeks post-birth, and one-year postpartum. RESULTS:Multilevel modeling of distress trajectories revealed greater decreases from pre-intervention to 12-months postpartum for those in MIL compared to TAU, especially among child-bearers who were higher in anxiety and/or lower in dispositional mindfulness at baseline. CONCLUSIONS:The current study offers preliminary evidence for durable perinatal mental health benefits following a brief mindfulness-based program and suggests further investigation of these effects in larger samples is warranted. TRIAL REGISTRATION:The ClinicalTrials.gov identifier for the study is: NCT02327559 . The study was retrospectively registered on June 23, 2014.

SUBMITTER: Sbrilli MD

PROVIDER: S-EPMC7559171 | biostudies-literature | 2020 Oct

REPOSITORIES: biostudies-literature

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Effects of prenatal mindfulness-based childbirth education on child-bearers' trajectories of distress: a randomized control trial.

Sbrilli Marissa D MD Duncan Larissa G LG Laurent Heidemarie K HK

BMC pregnancy and childbirth 20201015 1

<h4>Background</h4>The perinatal period is a time of immense change, which can be a period of stress and vulnerability for mental health difficulties. Mindfulness-based interventions have shown promise for reducing distress, but further research is needed to identify long-term effects and moderators of mindfulness training in the perinatal period.<h4>Methods</h4>The current study used data from a pilot randomized control trial (RCT) comparing a condensed mindfulness-based childbirth preparation ...[more]

PMID: 33059638

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Project description:BackgroundChildbirth fear is linked with lower labor pain tolerance and worse postpartum adjustment. Empirically validated childbirth preparation options are lacking for pregnant women facing this problem. Mindfulness approaches, now widely disseminated, can alleviate symptoms of both chronic and acute pain and improve psychological adjustment, suggesting potential benefit when applied to childbirth education.MethodsThis study, the Prenatal Education About Reducing Labor Stress (PEARLS) study, is a randomized controlled trial (RCT; n = 30) of a short, time-intensive, 2.5-day mindfulness-based childbirth preparation course offered as a weekend workshop, the Mind in Labor (MIL): Working with Pain in Childbirth, based on Mindfulness-Based Childbirth and Parenting (MBCP) education. First-time mothers in the late 3rd trimester of pregnancy were randomized to attend either the MIL course or a standard childbirth preparation course with no mind-body focus. Participants completed self-report assessments pre-intervention, post-intervention, and post-birth, and medical record data were collected.ResultsIn a demographically diverse sample, this small RCT demonstrated mindfulness-based childbirth education improved women's childbirth-related appraisals and psychological functioning in comparison to standard childbirth education. MIL program participants showed greater childbirth self-efficacy and mindful body awareness (but no changes in dispositional mindfulness), lower post-course depression symptoms that were maintained through postpartum follow-up, and a trend toward a lower rate of opioid analgesia use in labor. They did not, however, retrospectively report lower perceived labor pain or use epidural less frequently than controls.ConclusionsThis study suggests mindfulness training carefully tailored to address fear and pain of childbirth may lead to important maternal mental health benefits, including improvements in childbirth-related appraisals and the prevention of postpartum depression symptoms. There is also some indication that MIL participants may use mindfulness coping in lieu of systemic opioid pain medication. A large-scale RCT that captures real-time pain perceptions during labor and length of labor is warranted to provide a more definitive test of these effects.Trial registrationThe ClinicalTrials.gov identifier for the PEARLS study is: NCT02327559 . The study was retrospectively registered on June 23, 2014.

Project description:BackgroundPerinatal anxiety is one of the most common conditions during pregnancy and is associated with adverse maternal and neonatal outcomes. Interventions that are focused on childbirth education and health literacy have been shown to help decrease pregnancy-related anxiety. These programs, however, have limitations. Transportation, childcare, and work conflicts pose barriers to patients. In addition, many of these programs have not been studied in high-risk patients, who are most at risk for pregnancy-related anxiety. Thus, it is uncertain whether an online childbirth education course can help to improve outcomes in a high-risk patient population.ObjectiveThis study aimed to compare an interactive online platform for childbirth education (Birthly) with usual prenatal education on anxiety, emergency healthcare utilization, and delivery outcomes for high-risk pregnancies.Study designWe performed a randomized trial comparing an interactive online childbirth education platform combined with usual prenatal education (intervention) with usual prenatal education alone (usual care). Nulliparous, English-speaking patients with internet access and a high-risk pregnancy (medical or mental health disorders) were included. Patients in 2 urban clinics that serve underresourced patients were enrolled at <20 weeks of gestation. The intervention included 3 interactive courses (prenatal bootcamp, breastfeeding, newborn care) and access to a clinician-moderated online community. Pregnancy-related Anxiety Scale questionnaires were administered at randomization and at 34 to 40 weeks. The primary outcome was third-trimester Pregnancy-related Anxiety Scale score. Secondary outcomes included change in Pregnancy-related Anxiety Scale score, unscheduled emergency visits, delivery, and postpartum outcomes. To demonstrate a 15% decrease in Pregnancy-related Anxiety Scale score, 37 patients would be needed per group. Accounting for a 20% loss to follow-up rate, we planned to recruit 90 total patients or 45 per group.ResultsA total of 90 patients were randomized with no differences in demographics or baseline Pregnancy-related Anxiety Scale scores. Most patients self-identified as Black and were publicly insured. More than 60% of patients (62.2%) in the intervention arm completed at least 1 Birthly course. Patients in the intervention arm had significantly lower third-trimester Pregnancy-related Anxiety Scale scores (indicating lower anxiety) compared with those receiving usual care (44.6±7.3 vs 53.9±13.8; P<.01), with a decrease in score of 8.3 points vs 0.7 for usual care (P<.01). Patients in the intervention arm also had fewer emergency visits (1 [0-2] vs 2 [1-3]; P=.003). There were no differences in delivery outcomes. Patients in the intervention arm were more likely to breastfeed at delivery, although this was not different by the postpartum visit. Finally, patients who received the intervention were more likely to be satisfied with their childbirth education (94.6% vs 64.9%; P<.01).ConclusionAn interactive online childbirth education platform can reduce pregnancy-related anxiety and emergency healthcare utilization while improving satisfaction in a high-risk patient population.

Project description:BackgroundSleep deficiency affects a majority of pregnant women with significant impact on daily function, mood, and pregnancy and birth outcomes. This ongoing study combines two evidence-based strategies for improving sleep and mood, mindfulness meditation and cognitive-behavioral therapy for insomnia (CBT-I), in a unique online format to address the particular needs of pregnant women. The purpose of this study is to test the feasibility and estimate the efficacy of this novel 6-week online mindfulness meditation intervention to help pregnant women in remission from depression self-manage insomnia.MethodsThis is a two-arm, parallel group randomized controlled trial. A total of 50 pregnant women between 12 and 28 weeks gestation will be recruited from the community and randomly assigned to a mindfulness or education-only control group in a 1:1 ratio. During the study, all participants will complete six weekly online modules, daily sleep diaries, and optional participation in a treatment-specific online discussion forum. Feasibility outcome measures will include study recruitment, retention, intervention adherence (number of online modules completed, number of meditation days per week), and intervention acceptability (8-item questionnaire). The primary clinical outcome measure will be sleep quality measured with the Pittsburgh Sleep Quality Index. Secondary outcome measures will include sleep measured with actigraphy and diaries (sleep efficiency, total sleep time, total wake time), Patient-Reported Outcomes Measurement Information System (PROMIS) measures (fatigue, sleep-related impairment, sleep disturbance); mood (depression, anxiety, positive affect, quality of life); and self-management and behavior change (potential self-efficacy, self-regulation, sleep problem acceptance, and trait mindfulness). Assessments will occur at baseline and post-intervention; an additional acceptability survey will be completed 4 weeks postpartum. Analyses will examine within-group differences in outcome change scores from baseline to post-intervention. Open-ended feedback will be analyzed using qualitative content analysis.DiscussionThis research is innovative in addressing sleep in pregnancy using a self-management research design and methods that can be accessible and cost-effective for large numbers of pregnant women. The results from this study will inform intervention refinement and efficacy testing of the intervention in a larger randomized controlled trial.Trial registrationClinicalTrials.gov, NCT04016428. Registered on 11 July 2019. Updated version registered on 26 July 2019.

Project description:BACKGROUND:Psychological distress during pregnancy is common: up to 20% of the childbearing women experience symptoms of depression and anxiety. Apart from the adverse effects on the woman herself, pregnancy distress can negatively affect pregnancy outcomes, infant health, postpartum mother-child interaction and child development. Therefore, the development of interventions that reduce pregnancy distress is very important. Mindfulness-based interventions (MBIs) show promising positive effects on pregnancy distress, but there is a need for randomized controlled trials with sufficient power. Trials on online MBIs, which are readily accessible and not expensive, also show positive effects on stress reduction in non-pregnant populations. Moreover, specific working mechanisms of MBIs remain unclear. The aim of the current study is to test the effectiveness of an online MBI in pregnant women with pregnancy distress, as well as exploring potential working mechanisms. METHODS:The current study is a randomized controlled trial with repeated measures. Consenting women with elevated levels of pregnancy distress will be randomized into an intervention group (MBI) or control group (care as usual) around 12?weeks of pregnancy, with an intended sample size of 103 women in each group. The primary outcome, pregnancy distress, will be assessed via questionnaires at baseline, halfway through the intervention and post intervention in both intervention and control group, and after 8 weeks follow-up in the intervention group. Secondary outcomes are mindfulness skills, rumination and self-compassion, which are also seen as potential working mechanisms, and will be assessed via questionnaires before intervention, halfway through the intervention, post intervention and after 8 weeks follow-up in the intervention group. Tertiary outcome variables are obstetric data and will be collected from the obstetric records for both intervention and control group. Analyses will be based on the intention-to-treat principle. Multilevel regression models for repeated measures (mixed models) will be used to evaluate changes in primary and secondary outcome variables. Tertiary outcomes will be compared between groups using independent t-tests and Chi Square analyses. DISCUSSION:The trial is expected to increase knowledge about the effectiveness of online MBIs during pregnancy in women with pregnancy distress and to evaluate potential working mechanisms. TRIAL REGISTRATION:ClinicalTrials.gov: NCT03917745, registered on 4 March 2019. Protocol Version 3.0., 20 February 2020.

Project description:BACKGROUND:Diabetes distress (DD), a type of psychological distress specific to people with diabetes, is strongly associated with difficulties in performing self-care and inability to meet glycemic targets. Despite increased recognition of the need to manage DD, interventions that are both feasible and effective for reducing DD in routine care settings are not yet known. A pilot study showed that health coaching (HC) has some efficacy in addressing DD, but no adequately powered study has implemented a pragmatic research design capable of assessing the real-world effectiveness of HC in reducing DD. OBJECTIVE:The aim of this study is to describe the rationale and design of an ongoing clinical trial, Coaching and Education for Diabetes Distress trial, that seeks to assess whether HC effectively reduces DD among primary care patients with diabetes and whether HC is more effective than an educational program targeting DD. METHODS:The 2-arm randomized controlled trial is taking place at an academic family medicine practice in Houston, Texas. Both arms will receive usual care, which includes education about DD. In addition, the intervention arm will receive 8 HC sessions over a 5-month period. The primary outcome measure is reduction in DD over a 6-month period. Additional outcome measures include changes in hemoglobin A1c and self-care practices (medication-taking, dietary, and physical activity behaviors). RESULTS:As of March 2019, screening and recruitment are ongoing, and the results are expected by July 2020. CONCLUSIONS:HC is feasible in primary care and has been successfully applied to improving chronic disease self-management and outcomes. This study will provide evidence as to whether it has significant value in addressing important unmet psychological and behavioral needs of patients with diabetes. TRIAL REGISTRATION:ClinicalTrials.gov NCT03617146; https://clinicaltrials.gov/ct2/show/NCT03617146 (Archived by WebCite at http://www.webcitation.org/76Va37dbO). INTERNATIONAL REGISTERED REPORT IDENTIFIER (IRRID):DERR1-10.2196/12166.

Dataset Information

Effects of prenatal mindfulness-based childbirth education on child-bearers' trajectories of distress: a randomized control trial.

Publications

Effects of prenatal mindfulness-based childbirth education on child-bearers' trajectories of distress: a randomized control trial.

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