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Online Prenatal Trial in Mindfulness Sleep Management (OPTIMISM)

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ClinicalTrials.gov Identifier: NCT04016428
Recruitment Status : Recruiting
First Posted : July 11, 2019
Last Update Posted : July 26, 2019
Sponsor:
Collaborator:
National Institute of Nursing Research (NINR)
Information provided by (Responsible Party):
Ira Kantrowitz-Gordon, University of Washington

Tracking Information
First Submitted Date  ICMJE June 18, 2019
First Posted Date  ICMJE July 11, 2019
Last Update Posted Date July 26, 2019
Estimated Study Start Date  ICMJE July 2019
Estimated Primary Completion Date May 2020   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: July 9, 2019)
Pittsburgh Sleep Quality Index (PSQI) [ Time Frame: Enrollment to intervention completion (6 weeks) ]
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.
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: July 9, 2019)
  • Sleep efficiency [ Time Frame: Enrollment to intervention completion (6 weeks) ]
    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 [ Time Frame: Enrollment to intervention completion (6 weeks) ]
    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 [ Time Frame: Enrollment to intervention completion (6 weeks) ]
    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 [ Time Frame: Enrollment to intervention completion (6 weeks) ]
    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 [ Time Frame: Enrollment to intervention completion (6 weeks) ]
    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 [ Time Frame: Enrollment to intervention completion (6 weeks) ]
    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) [ Time Frame: Enrollment to intervention completion (6 weeks) ]
    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 [ Time Frame: Enrollment to intervention completion (6 weeks) ]
    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 [ Time Frame: Enrollment to intervention completion (6 weeks) ]
    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 [ Time Frame: Enrollment to intervention completion (6 weeks) ]
    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 [ Time Frame: Enrollment to intervention completion (6 weeks) ]
    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 [ Time Frame: Intervention completion (6 weeks) ]
    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 [ Time Frame: Intervention completion (6 weeks) ]
    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 [ Time Frame: Intervention completion (6 weeks) ]
    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.
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures
 (submitted: July 9, 2019)
  • PROMIS Self-Efficacy for Managing Emotions -- Short Form [ Time Frame: Enrollment to intervention completion (6 weeks) ]
    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.
  • Index of Self-Regulation (ISR) [ Time Frame: Enrollment to intervention completion (6 weeks) ]
    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.
  • Sleep Problem Acceptance Questionnaire (SPAQ) [ Time Frame: Enrollment to intervention completion (6 weeks) ]
    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.
  • Five Facet Mindfulness Questionnaire Short Form (FFMQ-SF) [ Time Frame: Enrollment to intervention completion (6 weeks) ]
    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.
Original Other Pre-specified Outcome Measures Same as current
 
Descriptive Information
Brief Title  ICMJE Online Prenatal Trial in Mindfulness Sleep Management
Official Title  ICMJE Online Prenatal Trial in Mindfulness Sleep Management
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:

  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  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Treatment
Condition  ICMJE
  • Pregnancy Related
  • Insomnia
  • Depression
Intervention  ICMJE
  • Behavioral: OPTIMISM
    Six-week online program that emphasizes mindfulness and skills for improving sleep during pregnancy.
  • Behavioral: Sleep Education
    Six-week online program that provides education on sleep during pregnancy.
Study Arms  ICMJE
  • 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.
    Intervention: Behavioral: OPTIMISM
  • 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.
    Intervention: Behavioral: Sleep Education
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Recruiting
Estimated Enrollment  ICMJE
 (submitted: July 9, 2019)
50
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE May 2020
Estimated Primary Completion Date May 2020   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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.

Sex/Gender  ICMJE
Sexes Eligible for Study: Female
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE
Contact: Ira Kantrowitz-Gordon, PhD, CNM (206) 543-8231 irakg@uw.edu
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT04016428
Other Study ID Numbers  ICMJE STUDY00005267
5P30NR016585-02 ( U.S. NIH Grant/Contract )
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE
Plan to Share IPD: Yes
Plan Description: Data will be shared via the Common Data Repository for Nursing Science (cdRNS) at the National Institute of Nursing Research.
Supporting Materials: Study Protocol
Supporting Materials: Informed Consent Form (ICF)
Supporting Materials: Clinical Study Report (CSR)
Time Frame: Data will become available 6 months after study start-up and will continue to be available throughout the study.
Access Criteria: Steps to access data are available at https://cdrns.nih.gov/access-data
Responsible Party Ira Kantrowitz-Gordon, University of Washington
Study Sponsor  ICMJE University of Washington
Collaborators  ICMJE National Institute of Nursing Research (NINR)
Investigators  ICMJE
Principal Investigator: Ira Kantrowitz-Gordon, PhD, CNM University of Washington
PRS Account University of Washington
Verification Date July 2019

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP