Back to resultsOnline Prenatal Trial in Mindfulness Sleep Management (OPTIMISM)
Primary Purpose
Pregnancy Related, Insomnia, Depression
Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
OPTIMISM
Sleep Education
Sponsored by
About this trial
This is an interventional treatment trial for Pregnancy Related focused on measuring sleep, pregnancy, insomnia, depression, mindfulness
Eligibility Criteria
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.
Sites / Locations
- University of Washington
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
OPTIMISM Intervention
Sleep Education
Arm Description
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.
Participants will receive online delivery of an education program on sleep in pregnancy, along with the usual care they would receive from their provider.
Outcomes
Primary Outcome Measures
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.
Secondary Outcome Measures
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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 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.
Full Information
NCT ID
NCT04016428
First Posted
June 18, 2019
Last Updated
June 30, 2022
Sponsor
University of Washington
Collaborators
National Institute of Nursing Research (NINR)
1. Study Identification
Unique Protocol Identification Number
NCT04016428
Brief Title
Online Prenatal Trial in Mindfulness Sleep Management
Acronym
OPTIMISM
Official Title
Online Prenatal Trial in Mindfulness Sleep Management
Study Type
Interventional
2. Study Status
Record Verification Date
June 2022
Overall Recruitment Status
Completed
Study Start Date
July 1, 2019 (Actual)
Primary Completion Date
May 31, 2021 (Actual)
Study Completion Date
June 30, 2021 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Washington
Collaborators
National Institute of Nursing Research (NINR)
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes
5. Study Description
Brief Summary
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
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Pregnancy Related, Insomnia, Depression
Keywords
sleep, pregnancy, insomnia, depression, mindfulness
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
64 (Actual)
8. Arms, Groups, and Interventions
Arm Title
OPTIMISM Intervention
Arm Type
Experimental
Arm Description
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.
Arm Title
Sleep Education
Arm Type
Active Comparator
Arm Description
Participants will receive online delivery of an education program on sleep in pregnancy, along with the usual care they would receive from their provider.
Intervention Type
Behavioral
Intervention Name(s)
OPTIMISM
Intervention Description
Six-week online program that emphasizes mindfulness and skills for improving sleep during pregnancy.
Intervention Type
Behavioral
Intervention Name(s)
Sleep Education
Intervention Description
Six-week online program that provides education on sleep during pregnancy.
Primary Outcome Measure Information:
Title
Pittsburgh Sleep Quality Index (PSQI)
Description
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)
Secondary Outcome Measure Information:
Title
Sleep efficiency
Description
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)
Title
Total wake time
Description
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)
Title
Total sleep time
Description
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)
Title
Patient-Reported Outcomes Measurement Information System (PROMIS) Sleep Disturbance Short Form
Description
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.
Time Frame
Enrollment to intervention completion (6 weeks)
Title
PROMIS Sleep-Related Impairment Short Form
Description
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)
Title
PROMIS Fatigue Short Form
Description
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)
Title
Edinburgh Postnatal Depression Scale (EPDS)
Description
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)
Title
PROMIS Depression Short Form
Description
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)
Title
PROMIS Anxiety Short Form
Description
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)
Title
Neuro-QOL Positive Affect and Well-Being Short Form
Description
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)
Title
Short Form (36) Health Survey
Description
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)
Title
Intervention adherence
Description
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)
Title
Meditation adherence
Description
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)
Title
Intervention acceptability
Description
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)
Other Pre-specified Outcome Measures:
Title
PROMIS Self-Efficacy for Managing Emotions -- Short Form
Description
A four-item self-report questionnaire for measuring confidence in handling emotions. Total scores range from 4 to 20, with higher scores indicated greater ability to handle emotions. Increased confidence is a better outcome.
Time Frame
Enrollment to intervention completion (6 weeks)
Title
Index of Self-Regulation (ISR)
Description
A nine-item self-report questionnaire designed to measure individuals' level of motivation and self-regulation for health-related behavior change. Total scores range from 6 to 54, with higher scores indicating greater self-regulation. Increased self-regulation is a better outcome.
Time Frame
Enrollment to intervention completion (6 weeks)
Title
Sleep Problem Acceptance Questionnaire (SPAQ)
Description
An 8-item self-report questionnaire that assesses acceptance of insomnia. Total scores range from 0 to 48, with higher scores indicating a higher level of acceptance. Increased acceptance is a better outcome.
Time Frame
Enrollment to intervention completion (6 weeks)
Title
Five Facet Mindfulness Questionnaire Short Form (FFMQ-SF)
Description
A 24-item self-report questionnaire that measures the trait-like tendency to be mindful in daily life. It includes five subscales, measuring different aspects of mindfulness. Four of the subscale scores range from 5 to 25; one subscale ("observing") has a range of 4 to 20. Higher scores indicate increased mindfulness, which is a better outcome.
Time Frame
Enrollment to intervention completion (6 weeks)
10. Eligibility
Sex
Female
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Ira Kantrowitz-Gordon, PhD, CNM
Organizational Affiliation
University of Washington
Official's Role
Principal Investigator
Facility Information:
Facility Name
University of Washington
City
Seattle
State/Province
Washington
ZIP/Postal Code
98195
Country
United States
12. IPD Sharing Statement
Plan to Share IPD
Yes
IPD Sharing Plan Description
Data will be shared via the Common Data Repository for Nursing Science (cdRNS) at the National Institute of Nursing Research.
IPD Sharing Time Frame
Data will become available 6 months after study start-up and will continue to be available throughout the study.
IPD Sharing Access Criteria
Steps to access data are available at https://cdrns.nih.gov/access-data
Citations:
PubMed Identifier
32944276
Citation
Kantrowitz-Gordon I, McCurry SM, Landis CA, Lee R, Wi D. Online prenatal trial in mindfulness sleep management (OPTIMISM): protocol for a pilot randomized controlled trial. Pilot Feasibility Stud. 2020 Sep 14;6:128. doi: 10.1186/s40814-020-00675-1. eCollection 2020.
Results Reference
derived
Learn more about this trial
Online Prenatal Trial in Mindfulness Sleep Management
We'll reach out to this number within 24 hrs