The aim of this study is to assess an online mindfulness intervention for pregnant women (6 weeks) for the treatment of insomnia and prevention of depression relapse in pregnancy. This mindfulness intervention will also be compared with an online intervention (6 weeks) consisting only of education about insomnia in pregnancy. The principal hypothesis is that the mindfulness intervention will be more effective than the education-only intervention.
The aim of this study is to assess an online mindfulness intervention for pregnant women (6 weeks) for the treatment of insomnia and prevention of depression relapse in pregnancy. There will be two groups: 1. An online mindfulness intervention for pregnant women (6 weeks) that focuses on behaviors to overcome sleep difficulties in pregnancy. 2. An online control group that will receive information about sleep in pregnancy (6 weeks). Each group will be composed of 25 participants with a total sample of 50. The principal hypothesis is that the mindfulness intervention will be more effective than sleep education in the improvement of sleep and depression symptoms during pregnancy. The differences between the intervention and control group will be analyzed. The acceptability and usability of online content will also be assessed.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Enrollment
64
Six-week online program that emphasizes mindfulness and skills for improving sleep during pregnancy.
Six-week online program that provides education on sleep during pregnancy.
University of Washington
Seattle, Washington, United States
Pittsburgh Sleep Quality Index (PSQI)
Self-rating of overall sleep quality and disturbances using 7 sleep components. Total scores range from 0 to 21, with higher scores indicating worse sleep quality. PSQI global \>5 is highly sensitive and specific for distinguishing good and poor sleepers. A lower PSQI score is a better outcome.
Time frame: Enrollment to intervention completion (6 weeks)
Sleep efficiency
Sleep efficiency will be calculated from total sleep time divided by time in bed, as measured by 8 days of wrist actigraphy and sleep diaries. Increased sleep efficiency is a better outcome.
Time frame: Enrollment to intervention completion (6 weeks)
Total wake time
Total wake time will include all time spent in bed awake, measured in minutes. This will be measured by actigraphy and sleep diaries, and will be calculated as the sum of sleep onset latency (time from getting into bed to falling asleep) and wake after sleep onset (time awake after sleep onset). Decreased total wake time is a better outcome.
Time frame: Enrollment to intervention completion (6 weeks)
Total sleep time
Total sleep time is the sum of all time spent asleep, measured in minutes. This will be measured by actigraphy and sleep diaries, and calculated as the difference between time in bed and total wake time. Increased total sleep time is a better outcome.
Time frame: Enrollment to intervention completion (6 weeks)
Patient-Reported Outcomes Measurement Information System (PROMIS) Sleep Disturbance Short Form
A six-item self-report questionnaire that measures perception of the quality of sleep over the past seven days. Total score ranges from 6 to 30, with higher scores indicating more disturbed sleep. Decreased sleep disturbance is a better outcome.
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Time frame: Enrollment to intervention completion (6 weeks)
PROMIS Sleep-Related Impairment Short Form
An eight-item self-report questionnaire for perceptions of alertness, sleepiness, and tiredness during usual waking hours, and the perceived functional impairments during wakefulness associated with sleep problems or impaired alertness. Total scores range from 8 to 40, with higher scores indicating increased impairment over the past 7 days. Decreased impairment is a better outcome.
Time frame: Enrollment to intervention completion (6 weeks)
PROMIS Fatigue Short Form
A six-item self-report questionnaire for reporting subjective feelings of tiredness and the impact on the ability to function normally over the past seven days. Total scores range from 6 to 30, with higher scores indicating increased fatigue. Decreased fatigue is a better outcome.
Time frame: Enrollment to intervention completion (6 weeks)
Edinburgh Postnatal Depression Scale (EPDS)
A ten-item self-report questionnaire for depression symptoms in the past week validated for use during pregnancy and postpartum. Total scores range from 0 to 30, with higher scores indicating increased symptoms of depression. Decreased depression is a better outcome.
Time frame: Enrollment to intervention completion (6 weeks)
PROMIS Depression Short Form
A six-item self-report questionnaire for depression symptoms in the past week. Total scores range from 6 to 30, with higher scores indicating increased symptoms of depression. Decreased depression is a better outcome.
Time frame: Enrollment to intervention completion (6 weeks)
PROMIS Anxiety Short Form
A six-item self-report questionnaire for anxiety symptoms in the past week. Total scores range from 6 to 30, with higher scores indicating increased symptoms of anxiety. Decreased anxiety is a better outcome.
Time frame: Enrollment to intervention completion (6 weeks)
Neuro-QOL Positive Affect and Well-Being Short Form
A nine-item self-report questionnaire for recent frequency of positive emotions. Total scores range from 9 to 45, with higher scores indicating increased positive emotions. A higher score is a better outcome.
Time frame: Enrollment to intervention completion (6 weeks)
Short Form (36) Health Survey
A 36-item, patient-reported survey of patient health status and quality of life. Total scores range from 0 to 100, with lower scores indicating increased disability. Increased scores are a better outcome.
Time frame: Enrollment to intervention completion (6 weeks)
Intervention adherence
Intervention adherence will be measured as the number of intervention modules completed, with a range of 0 to 6. Increased modules completed indicates greater intervention adherence and is a better outcome.
Time frame: Intervention completion (6 weeks)
Meditation adherence
Meditation adherence will be measured by the average number of days per week the participant practiced at least one meditation, with a range of 0 to 7. Increased meditation adherence is a better outcome.
Time frame: Intervention completion (6 weeks)
Intervention acceptability
Acceptability will be measured by a self-report 8-item questionnaire on program satisfaction, utility, and ease of use. The range of total scores is 8 to 40, with higher scores indicating increased acceptability. Higher acceptability is a better outcome.
Time frame: Intervention completion (6 weeks)