Online Prenatal Trial in Mindfulness Sleep Management
Online Prenatal Trial in Mindfulness Sleep Management
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.
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.
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.