Pregnancy RelatedOPTIMISMNCT04016428
Online Prenatal Trial in Mindfulness Sleep Management
A study testing OPTIMISM and Sleep Education in people with Pregnancy Related and Insomnia, run by University of Washington at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Pregnancy Related, Insomnia, Depression
- What is being tested?
- OPTIMISM and Sleep Education
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 64 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Jul 2019to 30 Jun 2021
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
About this study
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.
Read the 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.
- Conditions
- Pregnancy Related, Insomnia, Depression
- Being tested
- OPTIMISM, Sleep Education
- Keywords
- sleep, pregnancy, insomnia, depression, mindfulness
- Medical subject headings
- Sleep Initiation and Maintenance Disorders, Depression
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
OPTIMISMBehavioural
Six-week online program that emphasizes mindfulness and skills for improving sleep during pregnancy.
Sleep EducationBehavioural
Six-week online program that provides education on sleep during pregnancy.
| Study group | Role | What they receive |
|---|---|---|
| OPTIMISM Intervention | Experimental | 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. Receives: Behavioral: OPTIMISM |
| Sleep Education | Active comparator | Participants will receive online delivery of an education program on sleep in pregnancy, along with the usual care they would receive from their provider. Receives: Behavioral: Sleep Education |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Enrollment to intervention completion (6 weeks)
Secondary outcomes (14)
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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: Intervention completion (6 weeks)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Jul 2019
- Study start1 Jul 2019
- Primary completion31 May 2021
- Study completion30 Jun 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Pregnancy RelatedStudies of the same condition, open and under way.
- More trials run by University of WashingtonThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 64 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Washington
- Sponsor type
- University, hospital or other
- Collaborators
- National Institute of Nursing Research (NINR)
- Responsible party
- Principal investigator, Ira Kantrowitz-Gordon, University of Washington
- Investigators
- Ira Kantrowitz-Gordon, PhD, CNM, Principal investigator, University of Washington
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04016428
- Sponsor's protocol ID
- STUDY00005267
- Other IDs
- 5P30NR016585-02
- Acronym
- OPTIMISM
- Status last verified
- Jun 2022
- First submitted
- 18 Jun 2019
- Last updated
- 5 Jul 2022
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: Data will be shared via the Common Data Repository for Nursing Science (cdRNS) at the National Institute of Nursing Research.
Publications
Wi D, Lee RY, Kantrowitz-Gordon I. Efficacy of online mindfulness for the treatment of insomnia in pregnancy: A randomized clinical trial. PLoS One. 2025 May 9;20(5):e0322931. doi: 10.1371/journal.pone.0322931. eCollection 2025.
PubMed 40343904Kantrowitz-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.
PubMed 32944276
Study at a glance
From the registry record, last updated by the sponsor on 5 Jul 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Online Prenatal Trial in Mindfulness Sleep Management
- ClinicalTrials.gov ID
- NCT04016428
- Acronym / sponsor ID
- OPTIMISM / STUDY00005267
- Conditions
- Pregnancy Related, Insomnia, Depression
- Keywords
- sleep, pregnancy, insomnia, depression, mindfulness
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 64 participants (actual)
- Lead sponsor
- University of WashingtonUniversity, hospital or other
- Collaborators
- National Institute of Nursing Research (NINR)
- Study start
- 1 Jul 2019 (actual)
- Primary completion
- 31 May 2021 (actual)
- Study completion
- 30 Jun 2021 (actual)
- First posted
- 11 Jul 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| OPTIMISM Intervention | Experimental | Behavioral: OPTIMISMParticipants 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. |
| Sleep Education | Active comparator | Behavioral: Sleep EducationParticipants will receive online delivery of an education program on sleep in pregnancy, along with the usual care they would receive from their provider. |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- 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.
Key exclusion criteria (1 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| OPTIMISMSix-week online program that emphasizes mindfulness and skills for improving sleep during pregnancy. | Behavioural | OPTIMISM Intervention |
| Sleep EducationSix-week online program that provides education on sleep during pregnancy. | Behavioural | Sleep Education |
Primary outcome
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.
14 secondary outcomes
Sleep efficiency
Time frame: Enrollment to intervention completion (6 weeks)
Total wake time
Time frame: Enrollment to intervention completion (6 weeks)
Total sleep time
Time frame: Enrollment to intervention completion (6 weeks)
Patient-Reported Outcomes Measurement Information System (PROMIS) Sleep Disturbance Short Form
Time frame: Enrollment to intervention completion (6 weeks)
PROMIS Sleep-Related Impairment Short Form
Time frame: Enrollment to intervention completion (6 weeks)
PROMIS Fatigue Short Form
Time frame: Enrollment to intervention completion (6 weeks)
Edinburgh Postnatal Depression Scale (EPDS)
Time frame: Enrollment to intervention completion (6 weeks)
PROMIS Depression Short Form
Time frame: Enrollment to intervention completion (6 weeks)
PROMIS Anxiety Short Form
Time frame: Enrollment to intervention completion (6 weeks)
Neuro-QOL Positive Affect and Well-Being Short Form
Time frame: Enrollment to intervention completion (6 weeks)
Short Form (36) Health Survey
Time frame: Enrollment to intervention completion (6 weeks)
Intervention adherence
Time frame: Intervention completion (6 weeks)
Meditation adherence
Time frame: Intervention completion (6 weeks)
Intervention acceptability
Time frame: Intervention completion (6 weeks)
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Jul 2022.
- Derived from this study: PubMed 40343904Wi D, Lee RY, Kantrowitz-Gordon I. Efficacy of online mindfulness for the treatment of insomnia in pregnancy: A randomized clinical trial. PLoS One. 2025 May 9;20(5):e0322931. doi: 10.1371/journal.pone.0322931. eCollection 2025.
- Derived from this study: PubMed 32944276Kantrowitz-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.
- Individual participant dataSharing planned: Yes. Data will be shared via the Common Data Repository for Nursing Science (cdRNS) at the National Institute of Nursing Research.
Related trials for Pregnancy Related
Recruiting
NightWare and Cardiovascular Health in Women With PTSD
Post Traumatic Stress Disorder, Cardiovascular Diseases
Enrolling by invitation
Testing Implementation Strategies to Support Clinic Fidelity to an Outpatient Hypertension Bundle
Pregnancy Related, Hypertension
Not yet recruitingObservational study
Obesity-Related Indices and Albuminuria in Type 2 Diabetes
Obesity and Diabetes Mellitus, Type 2, Albuminuria
RecruitingObservational study
Growing Little PEAPODS Study
Premature Birth, Premature Infant
Not yet recruiting
Transcranial Magnetic Stimulation for Methamphetamine Use Disorder During Pregnancy
Methamphetamine Use Disorder, Pregnancy
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Ira Kantrowitz-Gordon, PhD, CNM principal investigator
University of Washington
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing OPTIMISM and Sleep Education in people with Pregnancy Related and Insomnia, run by University of Washington at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 5 Jul 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Pittsburgh Sleep Quality Index (PSQI) (time frame: Enrollment to intervention completion (6 weeks)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04016428, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 5 Jul 2022.