Data from: Online prenatal trial in mindfulness sleep management (OPTIMISM)
Data files
Mar 26, 2025 version files 51.48 KB
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OPTIMISM_actigraphy_summary_03052025.xlsx
15.18 KB
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OPTIMISM_Survey_Outcomes_Final(2025-02-13)_redacted.xlsx
27.76 KB
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README.md
8.53 KB
Abstract
This is a two-arm, parallel-group randomized controlled trial. A total of 45 pregnant women between 12 and 28 weeks gestation were 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 completed six weekly online modules, daily sleep diaries, and optional participation in a treatment-specific online discussion forum. Feasibility outcome measures included 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 was sleep quality measured with the Pittsburgh Sleep Quality Index. Secondary outcome measures included 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 occurred at baseline and post-intervention; an additional acceptability survey was completed 4 weeks postpartum.
https://doi.org/10.5061/dryad.vt4b8gv39
Description of the data and file structure
This study tested an online mindfulness-based intervention for pregnant women with insomnia. Self-report surveys and objective sleep monitoring were collected pre-intervention and post-intervention in two groups: mindfulness intervention and education-only control.
Files and variables
File: OPTIMISM_actigraphy_summary_03052025.xlsx
Description: This file contains participants’ sleep-actigraphy data pre-intervention and post-intervention. Mean values are reported over up to 8 days (nights) of measurement.
Variables
- ID: unique participant identifier
- Intervention: allocation to intervention or control group
- no_of_days_of diary_or_actigraphy1: pre-intervention number of days sleep data recorded using diaries and actigraphy
- avg_Time_in_bed1: pre-intervention average total time in bed determined by sleep diary (minutes)
- avg_Total_sleep time1: pre-intervention average total sleep time determined by actigraphy (minutes)
- avg_Total_wake_time1: pre-intervention average total wake time determined by actigraphy (minutes)
- avg_Sleep_onset_latency1: pre-intervention average time in bed until fell asleep determined by actigraphy (minutes)
- avg_Wake_after_sleep_onset1: pre-intervention average time awake after sleep onset determined by actigraphy (minutes)
- avg_Sleep_efficiency1: pre-intervention average total sleep efficiency calculated from actigraphy (minutes)
- no_of_days_of diary_or_actigraphy2: post-intervention number of days sleep data recorded using diaries and actigraphy
- avg_Time_in_bed2: post-intervention average total time in bed determined by sleep diary (minutes)
- avg_Total_sleep time2: post-intervention average total sleep time determined by actigraphy (minutes)
- avg_Total_wake_time2: post-intervention average total wake time determined by actigraphy (minutes)
- avg_Sleep_onset_latency2: post-intervention average time in bed until fell asleep determined by actigraphy (minutes)
- avg_Wake_after_sleep_onset2: post-intervention average time awake after sleep onset determined by actigraphy (minutes)
- avg_Sleep_efficiency2: post-intervention average total sleep efficiency calculated from actigraphy (minutes)
File: OPTIMISM_Survey_Outcomes_Final(2025-02-13).xlsx
Description: This file contains participant survey data pre-intervention and post-intervention. A data dictionary is available in the second tab of the Excel file.
Variables
- ID: unique participant identifier
Demographics
- Intervention: allocation to intervention or control groups
- age: age in years (redacted to remove partial identifiers)
- race: self-selected racial identity (redacted to remove partial identifiers)
- ethnicity: self-selected ethnicity (Hispanic or not) (redacted to remove partial identifiers)
- education: participant’s highest level of education (redacted to remove partial identifiers)
- employment status: participant’s employment status (redacted to remove partial identifiers)
- Please specify: free text for “other” employment status (redacted to remove partial identifiers)
- Maritalstatus: marital status or partnership status (redacted to remove partial identifiers)
- householdmember: number of people living in participant’s in the household (redacted to remove partial identifiers)
Five Facet Mindfulness Questionnaire Short Form
- FFMQ_1: pre-intervention Five Facet Mindfulness Questionnaire (FFMQ) score
- FFMQ_2: post-intervention Five Facet Mindfulness Questionnaire (FFMQ) score
Pittsburgh Sleep Quality Index
- psqi_duration_1: pre-intervention Pittsburgh Sleep Quality Index (PSQI) sleep duration item
- psqi_duration_2: post-intervention Pittsburgh Sleep Quality Index (PSQI) sleep duration item
- psqi_sleepdisturbance_1: pre-intervention Pittsburgh Sleep Quality Index (PSQI) sleep disturbance item
- psqi_sleepdisturbance_2: post-intervention Pittsburgh Sleep Quality Index (PSQI) sleep disturbance item
- psqi_sleeplatency_1: pre-intervention Pittsburgh Sleep Quality Index (PSQI) sleep latency item
- psqi_sleeplatency_2: post-intervention Pittsburgh Sleep Quality Index (PSQI) sleep latency item
- psqi_daydysfunction_1: pre-intervention Pittsburgh Sleep Quality Index (PSQI) daytime dysfunction item
- psqi_daydysfunction_2: post-intervention Pittsburgh Sleep Quality Index (PSQI) daytime dysfunction item
- tmphse_1: pre-intervention sleep efficiency percentage
- tmphse_2: post-intervention sleep efficiency percentage
- sleepefficiency_score_1: pre-intervention Pittsburgh Sleep Quality Index (PSQI) calculated sleep efficiency
- sleepefficiency_score_2: post-intervention Pittsburgh Sleep Quality Index (PSQI) calculated sleep efficiency
- psqi_sleepquality_1: pre-intervention Pittsburgh Sleep Quality Index (PSQI) sleep quality
- psqi_sleepquality_2: post-intervention Pittsburgh Sleep Quality Index (PSQI) sleep quality
- psqi_needmeds_1: pre-intervention Pittsburgh Sleep Quality Index (PSQI) needing medications to sleep item
- psqi_needmeds_2: post-intervention Pittsburgh Sleep Quality Index (PSQI) needing medications to sleep item
- psqi_total_1: pre-intervention Pittsburgh Sleep Quality Index (PSQI) total score
- psqi_total_2: post-intervention Pittsburgh Sleep Quality Index (PSQI) total score
Other Outcome Measures
- sleep_disturbance_1: pre-intervention PROMIS measure Sleep Disturbance T-score
- sleep_disturbance_2: post-intervention PROMIS measure Sleep Disturbance T-score
- SRI_1: pre-intervention Sleep Related Impairment (SRI) score
- SRI_2: post-intervention Sleep Related Impairment (SRI) score
- self_efficacy_1: pre-intervention PROMIS Self-Efficacy Emotion Management Short Forms T-score
- self_efficacy_2: post-intervention PROMIS Self-Efficacy Emotion Management Short Forms T-score
- pawb_1: pre-intervention Neuro-QOL Positive Affect and Well-Being Short Form
- pawb_2: post-intervention Neuro-QOL Positive Affect and Well-Being Short Form
- fatigue_1: pre-intervention PROMIS Fatigue Short Form
- fatigue_2: post-intervention PROMIS Fatigue Short Form
- self_regulation_1: pre-intervention Index of Self-Regulation (ISR) score
- self_regulation_2: post-intervention Index of Self-Regulation (ISR) score
- spaq_1: pre-intervention Sleep Problem Acceptance Questionnaire (SPAQ) score
- spaq_2: post-intervention Sleep Problem Acceptance Questionnaire (SPAQ) score
Short Form Health Survey (SF_36) Questionnaire
- sf36_physfunc_1: pre-intervention Physical Functioning subscale score
- sf36_physfunc_2: post-intervention Physical Functioning subscale score
- sf36_role_lim_1: pre-intervention Role Limitations due to Physical Health subscale score
- sf35_role_lim_2: post-intervention Role Limitations due to Physical Health subscale score
- sf36_role_lim_emotion_1: pre-intervention Role Limitations due to Emotional Problems subscale score
- sf36_role_lim_emotion_2: post-intervention Role Limitations due to Emotional Problems subscale score
- sf36_energy_1: pre-intervention Energy/Fatigue subscale score
- sf36_energy_2: post-intervention Energy/Fatigue subscale score
- sf36_emotionalwellbeing_1: pre-intervention Emotional Wellbeing subscale score
- sf36_emotionalwellbeing_2: post-intervention Emotional Wellbeing subscale score
- sf36_socialfunctioning_1: pre-intervention Social Functioning subscale score
- sf36_socialfunctioning_2: post-intervention Social Functioning subscale score
- sf36_pain_1: pre-intervention Pain subscale score
- sf36_pain_2: post-intervention Pain subscale score
- sf36_generalhealth_1: post-intervention General Health Subscale score
- sf36_generalhealth_2: post-intervention General Health Subscale score
- epds_1: pre-intervention Edinburgh Postnatal Depression Scale score
- epds_2: post-intervention Edinburgh Postnatal Depression Scale score
- anxiety_1: pre-intervention PROMIS Emotional Distress - Anxiety Short Form score
- anxiety_2: post-intervention PROMIS Emotional Distress - Anxiety Short Form score
- sf36_total_1: pre-intervention Short Form Health Survey total score
- sf36_total_2: post-intervention Short Form Health Survey total score
Data are provided in Excel files. A second tab in each file includes a data dictionary with an explanation of the variable names and the codes (possible values) for each variable.
Study survey data were collected and managed using Research Electronic Data Capture (REDCap). Objective sleep data were collected using a combination of daily sleep diaries and nighttime actigraphy with an Actiwatch Spectrum Plus (Philips Respironics, Murrysville, PA). Participants were asked to wear the actigraph and keep sleep diaries for 8 days at baseline and post-intervention. Actigraphy-measured sleep variables included total sleep time (TST), defined as the number of minutes of all time spent asleep; sleep efficiency (SE), a measure of sleep quality calculated as the ratio of TST divided by total time in bed ×100, with values closer to 100 meaning more efficient (better) sleep; sleep onset latency (SOL), defined as the number of minutes from getting into bed to falling asleep; total wake time (TWT), defined as the total number of minutes spent awake during the rest period; and wake after sleep onset (WASO), defined as the number of minutes awake between time falling asleep and wake time.