Online Prenatal Trial in Mindfulness Sleep Management (OPTIMISM)

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.

Study Overview

• Status: Completed
• Conditions: Depression; Insomnia; Pregnancy Related
• Intervention / Treatment: Behavioral: OPTIMISM; Behavioral: Sleep Education

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:

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
• Enrollment (Actual): 64
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Washington
    • Seattle, Washington, United States, 98195
      • University of Washington

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Female

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: OPTIMISM Intervention; 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; Six-week online program that emphasizes mindfulness and skills for improving sleep during pregnancy.
Active Comparator: Sleep Education; 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; Six-week online program that provides education on sleep during pregnancy.

What is the study measuring?

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)

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
PROMIS Self-Efficacy for Managing Emotions -- Short Form	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.	Enrollment to intervention completion (6 weeks)
Index of Self-Regulation (ISR)	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.	Enrollment to intervention completion (6 weeks)
Sleep Problem Acceptance Questionnaire (SPAQ)	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.	Enrollment to intervention completion (6 weeks)
Five Facet Mindfulness Questionnaire Short Form (FFMQ-SF)	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.	Enrollment to intervention completion (6 weeks)

Collaborators and Investigators

• Sponsor: University of Washington
• Collaborators: National Institute of Nursing Research (NINR)
• Investigators: Principal Investigator: Ira Kantrowitz-Gordon, PhD, CNM, University of Washington

Publications and helpful links

General Publications

• 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.

Study record dates

Study Major Dates

• Study Start (Actual): July 1, 2019
• Primary Completion (Actual): May 31, 2021
• Study Completion (Actual): June 30, 2021

Study Registration Dates

• First Submitted: June 18, 2019
• First Submitted That Met QC Criteria: July 9, 2019
• First Posted (Actual): July 11, 2019

Study Record Updates

• Last Update Posted (Actual): July 5, 2022
• Last Update Submitted That Met QC Criteria: June 30, 2022
• Last Verified: June 1, 2022

More Information

Terms related to this study

• Keywords: sleep; depression; insomnia; pregnancy; mindfulness
• Additional Relevant MeSH Terms: Behavioral Symptoms; Mental Disorders; Nervous System Diseases; Sleep Disorders, Intrinsic; Dyssomnias; Sleep Wake Disorders; Depression; Sleep Initiation and Maintenance Disorders
• Other Study ID Numbers: STUDY00005267; 5P30NR016585-02 (U.S. NIH Grant/Contract)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD 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
• IPD Sharing Supporting Information Type: STUDY_PROTOCOL; ICF; CSR

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No