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

NCT05356364 · Status: ACTIVE_NOT_RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 100

Last updated 2025-12-09

No results posted yet for this 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

Interventions

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.

Sponsors & Collaborators

  • Henry Ford Health System

    lead OTHER

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
40 Years
Sex
FEMALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2023-02-01
Primary Completion
2026-04-30
Completion
2026-04-30

Countries

  • United States

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05356364 on ClinicalTrials.gov