Condition or disease | Intervention/treatment | Phase |
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Pregnancy Related Insomnia Depression | Behavioral: OPTIMISM Behavioral: Sleep Education | Not Applicable |
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:
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 (Clinical Trial) |
Estimated Enrollment : | 50 participants |
Allocation: | Randomized |
Intervention Model: | Parallel Assignment |
Masking: | Single (Outcomes Assessor) |
Primary Purpose: | Treatment |
Official Title: | Online Prenatal Trial in Mindfulness Sleep Management |
Actual Study Start Date : | July 1, 2019 |
Estimated Primary Completion Date : | May 31, 2021 |
Estimated Study Completion Date : | June 2021 |
Arm | Intervention/treatment |
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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.
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Behavioral: OPTIMISM
Six-week online program that emphasizes mindfulness and skills for improving sleep during pregnancy.
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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.
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Behavioral: Sleep Education
Six-week online program that provides education on sleep during pregnancy.
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Ages Eligible for Study: | 18 Years and older (Adult, Older Adult) |
Sexes Eligible for Study: | Female |
Accepts Healthy Volunteers: | No |
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.
Contact: Ira Kantrowitz-Gordon, PhD, CNM | (206) 543-8231 | irakg@uw.edu |
United States, Washington | |
University of Washington | Recruiting |
Seattle, Washington, United States, 98195 | |
Contact: Ira Kantrowitz-Gordon, PhD, CNM |
Principal Investigator: | Ira Kantrowitz-Gordon, PhD, CNM | University of Washington |
Tracking Information | |||||||||||||||
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First Submitted Date ICMJE | June 18, 2019 | ||||||||||||||
First Posted Date ICMJE | July 11, 2019 | ||||||||||||||
Last Update Posted Date | April 27, 2021 | ||||||||||||||
Actual Study Start Date ICMJE | July 1, 2019 | ||||||||||||||
Estimated Primary Completion Date | May 31, 2021 (Final data collection date for primary outcome measure) | ||||||||||||||
Current Primary Outcome Measures ICMJE |
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.
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Original Primary Outcome Measures ICMJE | Same as current | ||||||||||||||
Change History | |||||||||||||||
Current Secondary Outcome Measures ICMJE |
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Original Secondary Outcome Measures ICMJE | Same as current | ||||||||||||||
Current Other Pre-specified Outcome Measures |
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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:
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. |
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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 |
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Condition ICMJE |
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Intervention ICMJE |
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Study Arms ICMJE |
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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. | ||||||||||||||
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. |
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Recruitment Information | |||||||||||||||
Recruitment Status ICMJE | Recruiting | ||||||||||||||
Estimated Enrollment ICMJE |
50 | ||||||||||||||
Original Estimated Enrollment ICMJE | Same as current | ||||||||||||||
Estimated Study Completion Date ICMJE | June 2021 | ||||||||||||||
Estimated Primary Completion Date | May 31, 2021 (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. |
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Sex/Gender ICMJE |
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Ages ICMJE | 18 Years and older (Adult, Older Adult) | ||||||||||||||
Accepts Healthy Volunteers ICMJE | No | ||||||||||||||
Contacts ICMJE |
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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 ) |
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Has Data Monitoring Committee | Yes | ||||||||||||||
U.S. FDA-regulated Product |
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IPD Sharing Statement ICMJE |
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Responsible Party | Ira Kantrowitz-Gordon, University of Washington | ||||||||||||||
Study Sponsor ICMJE | University of Washington | ||||||||||||||
Collaborators ICMJE | National Institute of Nursing Research (NINR) | ||||||||||||||
Investigators ICMJE |
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PRS Account | University of Washington | ||||||||||||||
Verification Date | April 2021 | ||||||||||||||
ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |