Sleep to Reduce Incident Depression Effectively in Peripartum

Depression Clinical Trial

— STRIDE P  

Official title:

Sleep to Reduce Incident Depression Effectively in Peripartum

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT06430333
• Other study ID #: STRIDE P
• Status: Not yet recruiting
• Phase: N/A
• Start date: October 1, 2025
• Est. completion date: September 30, 2028

Study information

• Verified date: May 2024
• Source: Henry Ford Health System
• Contact: David A Kalmbach, PhD
• Phone: 248-325-3938
• Email: dkalmba1[@]hfhs.org
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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. Our team has 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, we 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. We will evaluate the effectiveness of PUMAS for alleviating insomnia and preventing PND across pregnancy and the first postpartum year. We will also investigate whether PUMAS engages a key candidate mechanism (high cognitive arousal) that is operative for addressing these clinical outcomes in the effectiveness context.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 500
• Est. completion date: September 30, 2028
• Est. primary completion date: September 30, 2028
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

1. Singleton pregnancy, gestational week 14-31 at screening.

2. DSM-5 Insomnia Disorder (=1 month duration).

3. Insomnia Severity Index (ISI) score = 11.

4. Edinburgh Postnatal Depression Scale score<13 at screening.

5. No current DSM-5 Major Depression.

6. Reliable internet access for treatment and assessments.

7. Not currently engaged in therapy for major depression or insomnia disorder.

Exclusion Criteria:

1. High risk pregnancy (pre-eclampsia, placenta previa w/ hemorrhage, other conditions deemed serious risk to mother or fetus; hypertension and diabetes are allowed).

2. Active suicidal intent.

3. Night or rotating shift work, anticipated travel across time 3 or more time zones in the 2 months after baseline screening.

4. Untreated RLS (treated RLS is OK).

5. Excessive daytime sleepiness; Epworth Sleepiness Scale>15.

6. Uncontrolled sleep or mental disorder inappropriate or unsafe for sleep restriction (narcolepsy, bipolar, epilepsy, etc.).

Related Conditions & MeSH terms

• Depression
• Depressive Disorder
• Insomnia

Intervention

Behavioral:
• Perinatal Understanding of Mindful Awareness for Sleep (PUMAS)
Mindfulness-based sleep program for pregnant women.

Other:
• Treatment-as-usual (TAU)
Usual practices from real-world care experiences.

Locations

Country	Name	City	State
United States	Henry Ford Medical Center	Novi	Michigan

Sponsors (1)

Lead Sponsor	Collaborator
Henry Ford Health System

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Insomnia effectiveness	The Insomnia Severity Index is a commonly used self-report measure of insomnia symptoms that has been validated in peripartum. ISI scores range from 0 to 28 with higher scores indicating greater insomnia severity.	We will examine change in ISI from Pretreatment Baseline to Posttreatment (8 weeks after baseline), and monthly across the first postpartum year.
Primary	Depression prevention	The Edinburgh Postnatal Depression Scale (EDPS) is the most widely use depression measure in pregnancy and postpartum. EPDS scores range from 0 to 30 with higher scores indicating greater depression severity.	We will examine onset of major depression (EPDS scores 13 or higher) at posttreatment (8 weeks after baseline) and assessed monthly across the first postpartum year.
Secondary	Pre-sleep cognitive arousal	The Pre-Sleep Arousal Scale's Cognitive factor (PSASC) is a self-report measure of nocturnal cognitive arousal that has been validated in peripartum. PSASC scores range 8 to 40 with higHEr scores indicating greater pre-sleep cognitive arousal.	We will examine change in PSASC from pretreatment to posttreatment (8 weeks later).