Online Prenatal Trial in Mindfulness Sleep Management

Study Overview
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Brief Summary
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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.

Detailed Description
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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: An online mindfulness intervention for pregnant women (6 weeks) that focuses on behaviors to overcome sleep difficulties in pregnancy. 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.

Official Title
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Online Prenatal Trial in Mindfulness Sleep Management

Conditions
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Pregnancy Related, Insomnia, Depression

Intervention / Treatment
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* Behavioral: OPTIMISM
* Behavioral: Sleep Education


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: 1) Viable pregnancy in second trimester (up to 28 weeks gestation); 2) prior diagnosis of depression currently in remission (score < 3 on the Patient Health Questionnaire (PHQ-2) depression screening questionnaire); 3) subjective report of insomnia (score > 7 on the Insomnia Severity Index); 4) age 18 or older; 5) access to an Internet-enabled smartphone, tablet, or computer; and 6) English fluency. Participants will not be excluded from participation if they are currently receiving psychotropic medications or psychotherapy. Exclusion Criteria: 1) Known severe congenital fetal anomalies, fetal demise, or expected neonatal death; 2) diagnosis of major depressive disorder within past 2 months; 3) other significant psychiatric illness requiring treatment; 4) current hospitalization; 5) prior diagnosis of obstructive sleep apnea or restless leg syndrome; 6) positive self-report screen for restless leg syndrome; 7) regular mindfulness or meditative practice (at least weekly); and 8) regular night-shift work.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: OPTIMISM Intervention<br>Participants will receive online delivery of a mindfulness-based program for improving sleep in pregnancy, along with the usual care they would receive from their provider. | Behavioral: OPTIMISM<br>* Six-week online program that emphasizes mindfulness and skills for improving sleep during pregnancy.<br>|
| Active Comparator: Sleep Education<br>Participants will receive online delivery of an education program on sleep in pregnancy, along with the usual care they would receive from their provider. | Behavioral: Sleep Education<br>* Six-week online program that provides education on sleep during pregnancy.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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. | Enrollment to intervention completion (6 weeks) | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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. | 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. | 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. | 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. | 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. | 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. | 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. | 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. | 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. | 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. | 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. | 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. | 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. | 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. | Intervention completion (6 weeks) | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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sleep, pregnancy, insomnia, depression, mindfulness