Improving Negative Stressful Perseverations in Insomnia to Revitalize Expecting Moms (INSPIRE)

Running, not enrolling · Not applicable

Conditions studied: Insomnia, Depression

In brief

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 and effectiveness of a mindfulness-based therapy for insomnia relative to cognitive-behavioral therapy for insomnia in pregnant women with insomnia and comorbid depression. The investigators aim to examine whether a mindfulness-based intervention effectiveness reduces symptoms of insomnia and comorbid depression.

Key facts

Study ID

NCT05356364

Run by

Henry Ford Health System

People needed

100

Starts

2023-02-01

Expected to finish

2026-04-30

Last updated by the study team

2025-12-09

Who can join

Age: 18 and older, up to 40. Sex: female. Healthy volunteers: not accepted.

You may qualify if…

• 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)

You may not qualify if…

• 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.).

Where it is running

• Henry Ford Medical Center — Novi, Michigan, United States

Full record on ClinicalTrials.gov

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