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Online mindfulness-based intervention for women with pregnancy distress: design of a randomized controlled trial.

ABSTRACT: 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.

SUBMITTER: Hulsbosch LP

PROVIDER: S-EPMC7069182 | biostudies-literature | 2020 Mar

REPOSITORIES: biostudies-literature

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Online mindfulness-based intervention for women with pregnancy distress: design of a randomized controlled trial.

Hulsbosch Lianne P LP Nyklíček Ivan I Potharst Eva S ES Meems Margreet M Boekhorst Myrthe G B M MGBM Pop Victor J M VJM

BMC pregnancy and childbirth 20200313 1

<h4>Background</h4>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 ef ...[more]

PMID: 32169030

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Project description:Clinically significant psychological distress in pregnancy is common, with epidemiological research suggesting that between 15 and 25 % of pregnant women experience elevated symptoms of stress, anxiety, and depression. Untreated psychological distress in pregnancy is associated with poor obstetrical outcomes, changes in maternal physiology, elevated incidence of child physical and psychological disorders, and is predictive of maternal postpartum mood disorders. Despite the wide-ranging impact of antenatal psychological distress on mothers and their children, there is a gap in our knowledge about the most effective treatments that are available for psychological distress experienced in pregnancy. Additionally, no trials have focused on potential physiological changes that may occur as a result of receiving mindfulness training in pregnancy. The proposed trial will determine the effectiveness of an 8-week modified Mindfulness-based Cognitive Therapy (MBCT) intervention delivered during pregnancy.A randomized controlled trial (RCT) design with repeated measures will be used to evaluate the effectiveness of MBCT to treat psychological distress in pregnancy. A sample of 60 consenting pregnant women aged 18 years and above will be enrolled and randomized to the experimental (MBCT) or control (treatment as usual) condition. Primary (e.g., symptoms of stress, depression, and anxiety), secondary (cortisol, blood pressure (BP), heart rate variability (HRV), and sleep) and other outcome data (e.g., psychological diagnoses) will be collected via a combination of laboratory visits and at-home assessments from both groups at baseline (T1), immediately following the intervention (T2), and at 3 months postpartum (T3). Descriptive statistics will be used to describe sample characteristics. Data will be analyzed using an intention-to-treat approach. Hierarchical linear models will be used to test intervention effects on primary and secondary outcomes.The trial is expected to improve knowledge about evidence-based treatments for psychological distress experienced in pregnancy and to evaluate the potential impact of mindfulness-based interventions on maternal physiology.ClinicalTrials.gov: NCT02214732 , registered on 7 August 2014. Protocol Version 2.0., 5 September 2016.

Project description:ObjectivesThe goal of the present study was to probe the effects of mindfulness practice in a naturalistic setting as opposed to a lab-based environment in the presence of continuous heart rate variability (HRV) measurements. The specific experimental goals were to examine the effects of a brief 10-day online-based mindfulness intervention on both chronic and acute HRV responses.MethodWe conducted a fully randomized 10-day longitudinal trial of mindfulness practice, explicitly controlling for practice effects with an active-control group (music listening) and a non-intervention control group. To assess chronic cardiovascular effects, we asked participants in the 3 groups to complete 2-day HRV pre- and post-intervention measurement sessions. Using this experimental setup enabled us to address training effects arising from mindfulness practice to assess physiological impact on daytime as well as nighttime (i.e. assessing sleep quality) on the underlying HRV response. To assess acute cardiovascular effects, we measured HRV in the 2 active intervention groups during each of the 10 daily mindfulness or music sessions. This allowed us to track the development of purported training effects arising from mindfulness practice relative to the active-control intervention in terms of changes in the HRV slope over the 10-day time-course.ResultsFirstly, for the acute phase we found increased HRV during the daily practice sessions in both the mindfulness and active-control group indicating that both interventions were effective in decreasing acute physiological stress. Secondly, for the chronic phase we found increased HRV in both the day- and nighttime indicating increased sleep quality, specifically in the mindfulness group.ConclusionThese results suggest causal effects in both chronic and acute phases of mindfulness practice in formerly naïve subjects and provides support for the argument that brief online-based mindfulness interventions exert positive impact on HRV.

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:Burnout is highly prevalent in residents. No randomized controlled trials have been conducted measuring the effects of Mindfulness-Based Stress Reduction (MBSR) on burnout in residents.To determine the effectiveness of MBSR in reducing burnout in residents.A randomized controlled trial comparing MBSR with a waitlist control group.Residents from all medical, surgical and primary care disciplines were eligible to participate. Participants were self-referred.The MBSR consisted of eight weekly 2.5-h sessions and one 6-h silent day.The primary outcome was the emotional exhaustion subscale of the Dutch version of the Maslach Burnout Inventory-Human Service Survey. Secondary outcomes included the depersonalization and reduced personal accomplishment subscales of burnout, worry, work-home interference, mindfulness skills, self-compassion, positive mental health, empathy and medical errors. Assessment took place at baseline and post-intervention approximately 3 months later.Of the 148 residents participating, 138 (93%) completed the post-intervention assessment. No significant difference in emotional exhaustion was found between the two groups. However, the MBSR group reported significantly greater improvements than the control group in personal accomplishment (p?=?0.028, d?=?0.24), worry (p?=?0.036, d?=?0.23), mindfulness skills (p?=?0.010, d?=?0.33), self-compassion (p?=?0.010, d?=?0.35) and perspective-taking (empathy) (p?=?0.025, d?=?0.33). No effects were found for the other measures. Exploratory moderation analysis showed that the intervention outcome was moderated by baseline severity of emotional exhaustion; those with greater emotional exhaustion did seem to benefit.The results of our primary outcome analysis did not support the effectiveness of MBSR for reducing emotional exhaustion in residents. However, residents with high baseline levels of emotional exhaustion did appear to benefit from MBSR. Furthermore, they demonstrated modest improvements in personal accomplishment, worry, mindfulness skills, self-compassion and perspective-taking. More research is needed to confirm these results.

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Online mindfulness-based intervention for women with pregnancy distress: design of a randomized controlled trial.

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Online mindfulness-based intervention for women with pregnancy distress: design of a randomized controlled trial.

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