Status:
ACTIVE_NOT_RECRUITING
Improving Negative Stressful Perseverations in Insomnia to Revitalize Expecting Moms (INSPIRE)
Lead Sponsor:
Henry Ford Health System
Conditions:
Insomnia
Depression
Eligibility:
FEMALE
18-40 years
Phase:
NA
Brief Summary
Nearly half of women develop insomnia during pregnancy, which is associated with increased risk for developing perinatal depression. The purpose of this research is to evaluate the implementability an...
Detailed Description
The investigators will conduct a pilot hybrid type 1 effectiveness-implementation randomized controlled trial (RCT) wherein 100 pregnant women with DSM-5 insomnia disorder and comorbid depression (Edi...
Eligibility Criteria
Inclusion
- Singleton pregnancy, gestational week 14-31.
- DSM-5 Insomnia Disorder (acute or chronic).
- Insomnia Severity Index (ISI) score ≥ 11.
- Edinburgh Postnatal Depression Scale (EPDS) score ≥ 10.
- Ensure adequate sleep opportunity.
- Age ≥ 18, English-speaking.
- Reliable internet access (treatment, assessments)
Exclusion
- High risk pregnancy (age \>40y, pre-eclampsia, any condition deemed serious risk to mother/fetus; hypertension and diabetes allowed).
- Active suicidal intent (ideation is allowed).
- Night or rotating shift work.
- Epworth Sleepiness Scale\>15 (Excessive sleepiness)
- Health condition unsafe for sleep restriction (bipolar, epilepsy, etc.).
Key Trial Info
Start Date :
February 1 2023
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
April 30 2026
Estimated Enrollment :
100 Patients enrolled
Trial Details
Trial ID
NCT05356364
Start Date
February 1 2023
End Date
April 30 2026
Last Update
December 9 2025
Active Locations (1)
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1
Henry Ford Medical Center
Novi, Michigan, United States, 48377