Telemedicine Mindfulness-based Therapy for Perinatal Insomnia: An Open-label Trial.
Completed · Not applicable
Conditions studied: Insomnia
In brief
Over half of pregnant and postpartum women experience clinical insomnia. However, treatment options are very limited for pregnant women and moms of newborns. Sleep aids are not considered safe during pregnancy and may increase risks about safety for mom and baby during postpartum. Recent clinical trials show that behavioral and mindfulness-based treatments can safely improve sleep and mood during pregnancy. Yet, no published studies to date have combined behavioral sleep treatment with mindfulness-based stress reduction to improve sleep and mood at the same time in pregnant and postpartum women. This study is the first to combine behavioral sleep strategies with mindfulness-meditation to improve sleep and psychological wellbeing of expecting and new moms. The purpose of this research study is to examine the effectiveness of a mindfulness-based intervention for prenatal insomnia via telemedicine format to improve sleep and mood as well as reduce stress in pregnant women.
Key facts
- Study ID
- NCT04443959
- Run by
- Henry Ford Health System
- People needed
- 12
- Starts
- 2022-08-15
- Expected to finish
- 2022-11-22
- Last updated by the study team
- 2022-12-14
Who can join
Age: 18 and older, up to 40. Sex: female. Healthy volunteers: not accepted.
You may qualify if…
- (1) Gestational age at time of study enrollment must be 18-30 weeks.
- (2) Insomnia Severity Index score of 11 or higher
- (3) age between 18 and 40 years
- (4) reliable and adequately fast internet connection at home, which is required to engage in online treatment and online study outcome assessments
You may not qualify if…
- (1) High risk pregnancy as reported by the patient, which includes but is not limited to pre-eclampsia, gestational diabetes, maternal age > 40, ectopic pregnancy, fetal problems (e.g., heart problems), hyperemesis gravidarum, placenta previa, and placental abruption.
- (2) bipolar disorder or seizure disorders [contraindicated for insomnia therapy] as reported by the patient
- (3) women with multiple pregnancy (e.g., twins, triplets, etc.) will not be eligible to participate as multiple pregnancy can increase risk of complications and often leads to preterm or early-term birth
- (4) any conditions or difficulties that would prevent the patient from completing online treatment and/or online surveys, including but not limited to language difficulties, literacy issues, visual or auditory impairment, and cognitive deficits
- (5) active suicidal intent
Where it is running
- Henry Ford Medical Center — Novi, Michigan, United States
Full record on ClinicalTrials.gov
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