Status:
COMPLETED
Online Prenatal Trial in Mindfulness Sleep Management
Lead Sponsor:
University of Washington
Collaborating Sponsors:
National Institute of Nursing Research (NINR)
Conditions:
Pregnancy Related
Insomnia
Eligibility:
FEMALE
18+ years
Phase:
NA
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 int...
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 g...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
July 1 2019
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
June 30 2021
Estimated Enrollment :
64 Patients enrolled
Trial Details
Trial ID
NCT04016428
Start Date
July 1 2019
End Date
June 30 2021
Last Update
July 5 2022
Active Locations (1)
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1
University of Washington
Seattle, Washington, United States, 98195