Sleep to Reduce Incident Depression Effectively in Peripartum

Status: Recruiting
Location: See location...
Intervention Type: Behavioral, Other
Study Type: Interventional
Study Phase: Phase 2
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.

Eligibility
Participation Requirements
Sex: Female
Minimum Age: 18
Healthy Volunteers: f
View:

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

• DSM-5 Insomnia Disorder (≥1 month duration).

• Insomnia Severity Index (ISI) score ≥ 11.

• Edinburgh Postnatal Depression Scale score\<13 at screening.

• No current DSM-5 Major Depression.

• Reliable internet access for treatment and assessments.

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

• Age 18 years or older.

Locations
United States
Michigan
Henry Ford Medical Center
RECRUITING
Novi
Contact Information
Primary
David A Kalmbach, PhD
dkalmba1@hfhs.org
248-325-3938
Backup
Christopher L Drake, PhD
cdrake1@hfhs.org
248-344-6672
Time Frame
Start Date: 2024-12-10
Estimated Completion Date: 2028-02-29
Participants
Target number of participants: 500
Treatments
Experimental: Perinatal Understanding of Mindful Awareness for Sleep (PUMAS)
PUMAS is a clinician-administered psychotherapy intervention for prenatal insomnia that includes six weekly 60-minute sessions in an individual format. PUMAS combines behavioral sleep strategies with mindfulness exercises and tailors all components to pregnancy to improve sleep quality. PUMAS will be delivered via telemedicine video.
Active_comparator: Treatment-as-usual (TAU)
TAU reflects real-world care where patients and their providers make their own treatment decisions for treating prenatal insomnia. Common TAU options include over-the-counter sleep aids, sleep hygiene education, melatonin, and cognitive-behavioral therapy for insomnia. The TAU group will be well-characterized (i.e., the investigators will monitor interventions administered by the usual care providers and collect information on dosage, frequency, duration, adherence) to best describe treatment options sought and completed in the real world.
Related Therapeutic Areas
Sponsors
Leads: Henry Ford Health System

This content was sourced from clinicaltrials.gov