Status:
COMPLETED
Telemedicine Mindfulness-based Therapy for Perinatal Insomnia: An Open-label Trial.
Lead Sponsor:
Henry Ford Health System
Conditions:
Insomnia
Eligibility:
FEMALE
18-40 years
Phase:
NA
Brief Summary
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 ...
Detailed Description
The purpose of this open-label trial is to determine the efficacy of and patient engagement in mindfulness-based intervention for prenatal insomnia delivered via telemedicine. The investigators' long-...
Eligibility Criteria
Inclusion
- (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
Exclusion
- (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
Key Trial Info
Start Date :
August 15 2022
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
November 22 2022
Estimated Enrollment :
12 Patients enrolled
Trial Details
Trial ID
NCT04443959
Start Date
August 15 2022
End Date
November 22 2022
Last Update
December 14 2022
Active Locations (1)
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1
Henry Ford Medical Center
Novi, Michigan, United States, 48377