Online Prenatal Trial in Mindfulness Sleep Management
Overview
- Phase
- N/A
- Intervention
- Not specified
- Conditions
- Pregnancy Related
- Sponsor
- University of Washington
- Enrollment
- 64
- Locations
- 1
- Primary Endpoint
- Pittsburgh Sleep Quality Index (PSQI)
- Status
- Completed
- Last Updated
- 3 years ago
Overview
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.
Investigators
Ira Kantrowitz-Gordon
Assistant Professor
University of Washington
Eligibility Criteria
Inclusion Criteria
- •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
- •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.
Outcomes
Primary Outcomes
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.
Secondary Outcomes
- Sleep efficiency(Enrollment to intervention completion (6 weeks))
- Total wake time(Enrollment to intervention completion (6 weeks))
- Total sleep time(Enrollment to intervention completion (6 weeks))
- PROMIS Sleep-Related Impairment Short Form(Enrollment to intervention completion (6 weeks))
- PROMIS Fatigue Short Form(Enrollment to intervention completion (6 weeks))
- Neuro-QOL Positive Affect and Well-Being Short Form(Enrollment to intervention completion (6 weeks))
- Patient-Reported Outcomes Measurement Information System (PROMIS) Sleep Disturbance Short Form(Enrollment to intervention completion (6 weeks))
- Edinburgh Postnatal Depression Scale (EPDS)(Enrollment to intervention completion (6 weeks))
- PROMIS Depression Short Form(Enrollment to intervention completion (6 weeks))
- PROMIS Anxiety Short Form(Enrollment to intervention completion (6 weeks))
- Short Form (36) Health Survey(Enrollment to intervention completion (6 weeks))
- Intervention adherence(Intervention completion (6 weeks))
- Meditation adherence(Intervention completion (6 weeks))
- Intervention acceptability(Intervention completion (6 weeks))