Sleep to Reduce Incident Depression Effectively in Peripartum

Part of paid clinical trials in Novi, Michigan.

Sponsor
Henry Ford Health System
Study ID
NCT06430333
Phase
PHASE2
Status
Recruiting
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Conditions

Eligibility Criteria

Sex
FEMALE
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • Perinatal Understanding of Mindful Awareness for Sleep (PUMAS) — BEHAVIORAL
    Mindfulness-based sleep program for pregnant women.
  • Treatment-as-usual (TAU) — OTHER
    Usual practices from real-world care experiences.

Study Details

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.

Key Dates

Start date
Dec 10, 2024
Status verified
Apr 2026
Primary completion
Feb 29, 2028
Completion
Feb 29, 2028

Study Design

Enrollment
500 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • 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.

Primary Outcome Measure

Comparative effectiveness between PUMAS and standard care on changes in insomnia symptoms. [ Time Frame: The investigators will examine change in ISI from Pretreatment Baseline to Posttreatment (8 weeks after baseline), and monthly for 1 year after childbirth.. ]

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
Henry Ford Medical CenterNoviMichigan48377
David Kalmbach, PhD
[email protected]
2483253938
Heba Afaneh, MA
[email protected]

Find similar trials in Novi, MI

By condition
DepressionInsomnia
By specialty
PsychiatryMental healthBehavioral healthSleep medicine
By research site
Henry Ford Medical Center· Novi, MI

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