Online prenatal trial in mindfulness sleep management (OPTIMISM): protocol for a pilot randomized controlled trial

Abstract

Background Sleep 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. Methods This 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. Discussion This 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 registration ClinicalTrials.gov, NCT04016428. Registered on 11 July 2019. Updated version registered on 26 July 2019.

Efficacy of Internet‐based cognitive behavioral therapy on sleeping difficulties in menopausal women: A randomized controlled trial

“…If the participants had any questions, they contacted the researchers through WhatsApp messages and telephone calls. The program incorporated three different interventions: (1) cognitive intervention (cognitive restructuring), (2) psychoeducation (sleep environment improvement), and (3) behavioral intervention (sleep hygiene education, stimulus control strategies, sleep restriction strategies, and relaxation training) (Kantrowitz‐Gordon et al, 2020). One of the researchers sent a reminder to the participants on the morning of the module execution.…”

Effectiveness of Online Mindfulness-Based Intervention on Depression in Pregnancy

“…A study states that mindfulness-based interventions can be delivered online with the same efficacy as face-to-face classes in reducing stress, depression, and anxiety ( (Spijkerman, Pots, & Bohlmeijer, 2016;Fish, Brimson ,& Lynch, 2016). Innovation with online mindfulness meditation for 6 weeks of pregnancy is a cost-effective intervention for a large number of pregnant women (Kantrowitz-Gordon et al, 2020) Given the increasing Internet presence, MBI can also be offered electronically. The results of a meta-analysis show that electronic MBI (eMBI) positively impacts mental health (Spijkerman, Pots, & Bohlmeijer, 2016).…”