NCT05356364

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

• Status: Active Not Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 100 (estimated)
• Sponsor: Henry Ford Health System · Academic / Other
• Sex: Female
• Age: 18 Years – 40 Years
• Healthy volunteers: Not accepted

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.

Detailed description

The investigators will conduct a pilot hybrid type 1 effectiveness-implementation randomized controlled trial (RCT) wherein 100 pregnant women with DSM-5 insomnia disorder and comorbid depression (Edinburgh Postnatal Depression Scale ≥ 10) are randomized to a mindfulness-based intervention--Perinatal Understanding of Mindful Awareness for Sleep (PUMAS)--or Cognitive Behavioral Therapy for Insomnia (CBTI). Patients will be recruited from women's health clinics across Henry Ford Health in Metro Detroit including underserved women, serving as real-world implementation. Per clinic operations since the pandemic, therapies will be via telemedicine to meet patient expectations. Study outcomes will be assessed before and after treatment, then across the first postpartum year.

Conditions

• Insomnia
• Depression

Interventions

Type	Name	Description
BEHAVIORAL	Cognitive Behavioral Therapy for Insomnia (CBTI)	cognitive and behavioral treatment for perinatal insomnia.
BEHAVIORAL	Perinatal Understanding of Mindful Awareness for Sleep (PUMAS)	Mindfulness and behavioral based therapy for perinatal insomnia.

Timeline

• Start date: 2023-02-01
• Primary completion: 2026-04-30
• Completion: 2026-04-30
• First posted: 2022-05-02
• Last updated: 2025-12-09

Locations

1 site across 1 country: United States