Status:
COMPLETED
Improving Negative Stressful Perseverations in Insomnia to Revitalize Expectant Moms
Lead Sponsor:
Henry Ford Health System
Conditions:
Insomnia
Eligibility:
FEMALE
18-40 years
Phase:
NA
Brief Summary
The purpose of this research is to evaluate telemedicine treatments for sleep in pregnant women. As pregnant women are vulnerable to sleep problems, the investigators aim to explore whether these type...
Detailed Description
The purpose of this randomized controlled trial is to determine the efficacy of cognitive behavioral therapy for insomnia (CBTI) and mindfulness-based therapy for insomnia (MBTI) for perinatal insomni...
Eligibility Criteria
Inclusion
- (1) Gestational age at time of study enrollment must be less than or equal to 28 weeks
- (2) Insomnia Severity Index score \> 10
- (3) age 18 - 40 years
- (4) reliable and adequately fast internet connection at home, which is required to engage in telemedicine treatment (online video) and online study outcome assessments.
Exclusion
- High risk pregnancy (e.g., pre-eclampsia, multiple pregnancy, age\>40)
- Bipolar disorder (contraindicated for CBTI)
- Seizures (contraindicated for CBTI)
- Active suicidal intent
- Shift work
- Patients who cannot reasonably engage in study activities including treatment or completing online surveys will be excluded regardless of reason. This may include inability to comprehend the English language, inability to hear therapist over video sessions, inability to understand and meaningfully answer study outcomes measures, or other barriers to participation.
Key Trial Info
Start Date :
March 15 2021
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
December 31 2023
Estimated Enrollment :
64 Patients enrolled
Trial Details
Trial ID
NCT04445805
Start Date
March 15 2021
End Date
December 31 2023
Last Update
January 19 2024
Active Locations (1)
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1
Henry Ford Medical Center
Novi, Michigan, United States, 48377