Ignite Creation Date:
2025-12-25 @ 3:03 AM
Ignite Modification Date:
2026-03-03 @ 7:21 PM
Study NCT ID:
NCT06430333
Status:
RECRUITING
Last Update Posted:
2025-02-24
First Post:
2024-05-21
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Sleep to Reduce Incident Depression Effectively in Peripartum
Sponsor:
Henry Ford Health System
Organization:
Study Overview
Official Title:
Sleep to Reduce Incident Depression Effectively in Peripartum
Status:
RECRUITING
Status Verified Date:
2025-02
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
STRIDE P
Brief Summary:
Perinatal depression (PND) is the most common complication in pregnancy and postpartum, which increases risk for adverse perinatal outcomes such as preterm birth, maternal suicidal thoughts, and impaired mother-infant bonding. Insomnia often precedes PND cases and may serve as an entry point for interventions preventing PND. The proposed project is a large-scale clinical trial to test the effectiveness of a mindfulness-based sleep program designed for pregnant women to improve sleep and alleviate cognitive arousal to reduce risk for PND across pregnancy and postpartum.
Detailed Description:
Perinatal depression (PND) affects nearly 20% of pregnant and postpartum women, with estimates soaring above 30% during the COVID-19 pandemic. Prospective data show insomnia often precedes PND incidence and relapse cases by more than doubling risk for major depression. This is highly relevant to a large segment of the pregnant population as \~20% of women meet diagnostic criteria for insomnia disorder by the end of pregnancy. Fortunately, insomnia is a modifiable risk factor for PND, and insomnia may serve as an entry point to prevent PND incidence and relapse. The investigators have identified cognitive arousal as a promising candidate factor for alleviating insomnia and preventing depression via insomnia therapy. Indeed, undertreatment of cognitive arousal in pregnancy is associated with insomnia non-remission and continued depression after therapy. Moreover, patient stakeholders identify 'calming a busy mind at night' as a critical target for improving sleep during pregnancy. In effort to enhance alleviation of cognitive arousal to optimize clinical outcomes, the investigators developed Perinatal Understanding of Mindful Awareness for Sleep (PUMAS). PUMAS places behavioral sleep strategies within a mindfulness intervention framework to develop an insomnia therapy specifically for pregnant women: RCT data show that PUMAS yields large effects on insomnia, depression, and cognitive arousal.
This study is a hybrid effectiveness-implementation RCT of 500 women with DSM-5 insomnia disorder (without PND) who are randomized to PUMAS or treatment-as-usual. The investigators will evaluate the effectiveness of PUMAS for alleviating insomnia and preventing PND across pregnancy and the first postpartum year. The investigators will also evaluate whether PUMAS engages a key candidate mechanism (high cognitive arousal) that is operative for addressing these clinical outcomes in the effectiveness context.
This study is a hybrid effectiveness-implementation RCT of 500 women with DSM-5 insomnia disorder (without PND) who are randomized to PUMAS or treatment-as-usual. The investigators will evaluate the effectiveness of PUMAS for alleviating insomnia and preventing PND across pregnancy and the first postpartum year. The investigators will also evaluate whether PUMAS engages a key candidate mechanism (high cognitive arousal) that is operative for addressing these clinical outcomes in the effectiveness context.
Study Oversight
Has Oversight DMC:
True
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
False
Is an FDA AA801 Violation?: