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Improving Negative Stressful Perseverations in Insomnia to Revitalize Expecting Moms (INSPIRE)
NCT05356364 · View on ClinicalTrials.gov ↗
Study 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 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.
Conditions Studied
Interventions
- BEHAVIORAL Perinatal Understanding of Mindful Awareness for Sleep (PUMAS)
- BEHAVIORAL Cognitive Behavioral Therapy for Insomnia (CBTI)
Study Locations (1)
Michigan
- Henry Ford Medical Center — Novi
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 100 participants |
| Start Date | 2023-02-01 |
| Est. Completion | 2026-04-30 |
| Phase | NA |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT05356364
The ClinicalTrials.gov registry entry for NCT05356364 describes a study currently listed as active not recruiting. It is categorized as NA, which is the standard way researchers label where a study sits along the investigational pathway from early safety work through later efficacy and post-marketing evaluation. The registered enrollment target is 100 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Henry Ford Health System, which has 171 total studies on file at ClinicalTrials.gov, and sponsors are the parties responsible for study design, oversight, and regulatory filings.
The record links to 2 conditions, with Depression appearing as the primary indexed condition, and to 2 interventions — of which Perinatal Understanding of Mindful Awareness for Sleep (PUMAS) is the first listed. Interventions can include drugs, devices, procedures, behavioral programs, or observational arms, and each is tracked as a separate registry field so that downstream queries can filter accurately. When a trial lists multiple interventions, it usually reflects a multi-arm design or a comparison protocol rather than a single treatment being tested in isolation. The brief summary published in the registry is the clearest source of protocol intent and should be read before drawing conclusions from any sidebar tags.
Geographic footprint matters for practical reasons: NCT05356364 reports 1 study location spanning 1 distinct geographic area — top geographies include Michigan. A larger site network tends to correlate with broader recruitment capacity, but it does not imply anything about study quality, and site-level enrollment status can diverge from the overall registry status shown above. Every data point on this page comes from the public ClinicalTrials.gov dataset and is reproduced here for reference only; it is not a medical recommendation, an endorsement of the sponsor, or an invitation to enroll. Verify current status, eligibility criteria, and contact details directly at ClinicalTrials.gov, and discuss any participation decision with your own healthcare provider.
Frequently Asked Questions
What is clinical trial NCT05356364 about?
NCT05356364 is a clinical study titled "Improving Negative Stressful Perseverations in Insomnia to Revitalize Expecting Moms (INSPIRE)". 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...
What is the current status of trial NCT05356364?
This trial is currently active not recruiting. It is a NA study. The enrollment target is 100 participants. The study started on 2023-02-01. Estimated completion is 2026-04-30.
What conditions does trial NCT05356364 study?
This clinical trial studies the following conditions: Depression, Insomnia. These conditions were identified from the trial registry and reflect the primary focus areas of the research.
What interventions are being tested in trial NCT05356364?
The interventions under investigation include: Perinatal Understanding of Mindful Awareness for Sleep (PUMAS) (BEHAVIORAL), Cognitive Behavioral Therapy for Insomnia (CBTI) (BEHAVIORAL). Each intervention is being evaluated for safety and efficacy as part of this clinical study.
Who is sponsoring clinical trial NCT05356364?
This trial is sponsored by Henry Ford Health System, which has 171 total clinical trials registered on ClinicalTrials.gov. The sponsor is responsible for the study's design, funding, and regulatory compliance.
Where is trial NCT05356364 being conducted?
This trial has 1 study location across Michigan. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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