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NCT05356364 · ClinicalTrials.gov registry record · NA
Improving Negative Stressful Perseverations in Insomnia to Revitalize Expecting Moms (INSPIRE)
A NA study of Depression and Insomnia, sponsored by Henry Ford Health System.
- Active
- Registry status
- NA
- Development phase
- 100
- Enrollment target
- 1
- Study location
NCT05356364: Active NA study of Depression and Insomnia, sponsored by Henry Ford Health System.
NCT05356364 is a NA study of Depression and Insomnia that is active but no longer recruiting, run by Henry Ford Health System. The registered enrollment target is 100 participants, below the 786-participant average among 679 other Depression trials with a reported enrollment target (87% lower). The trial reports 1 study location across 1 state. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT05356364, a NA study of Depression and Insomnia, is active but no longer recruiting, sponsored by Henry Ford Health System.
- ACTIVE NOT RECRUITING
- Registry status
- NA
- Development phase
- 100 participants
- Enrollment target
- 1
- Study location
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.
Primary Outcome
The Insomnia Severity Index (ISI) is a commonly used self-report measure of insomnia symptoms that has been validated in a perinatal sample. The ISI scores range from 0-28 with higher scores indicating greater insomnia severity.
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 |
What the registry record for NCT05356364 still lists
NCT05356364 is an interventional study that assigns participants to a tested intervention. The registered 100 participants enrollment target is mid-sized for trials with a published cap, below the 786-participant average among 679 other Depression trials with a reported enrollment target (87% lower).
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.
NCT05356364 reports a single indexed study location in Michigan.
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.
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).
Who is sponsoring clinical trial NCT05356364?
This trial is sponsored by Henry Ford Health System, which has 234 total clinical trials registered on ClinicalTrials.gov.
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.
Learn More About Clinical Trials
Similar trials for Depression
Matched on the same primary condition, ranked to surface studies in the same phase first, then by recruiting status, no relevance scoring or editorial curation.
Where NCT05356364's enrollment target sits among peer trials
100 326th of 679 higher than 331 of 679 other Depression trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Depression trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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