Recruiting
Phase 2

Sleep

Sponsor:

Henry Ford Health System

Code:

NCT06430333

Conditions

Insomnia

Depression

Eligibility Criteria

Sex: Female

Age: 18+

Healthy Volunteers: Not accepted

Interventions

Perinatal Understanding of Mindful Awareness for Sleep (PUMAS)

Treatment-as-usual (TAU)

Study Details

Brief 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.

Conditions

Insomnia

Depression

Study ID

NCT06430333

Start date

Dec 10, 2024

Status verified date

Apr, 2026

Completion date

Feb 29, 2028

Anticipated

Primary completion date

Feb 29, 2028

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: Female

Age: 18+

Healthy Volunteers: Not accepted

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.
8. Age 18 years or older.

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.).

Study Design

Enrollment

500 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Treatment

Interventions and Outcome Measures

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.

Interventions

Perinatal Understanding of Mindful Awareness for Sleep (PUMAS)

Mindfulness-based sleep program for pregnant women.

Treatment-as-usual (TAU)

Usual practices from real-world care experiences.

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.. ]
  • Comparative effectiveness of PUMAS and standard care on prevention of perinatal depression. [ Time Frame: The investigators will examine onset of perinatal depression (EPDS scores 13 or higher) at posttreatment (8 weeks after baseline) and assessed monthly for 1 year after childbirth. ]

Central Contacts and Locations

Central contacts

David A Kalmbach, PhD

248-325-3938dkalmba1@hfhs.org

Christopher L Drake, PhD

248-344-6672cdrake1@hfhs.org

Locations

Henry Ford Medical Center

Recruiting

Novi, Michigan, United States, 48377

Contacts

David Kalmbach, PhD

2483253938dkalmbach1@hfhs.org

Heba Afaneh, MA

hafaneh1@hfhs.org

More Information

Sponsor

Henry Ford Health System

Last update posted

Apr 17, 2026

Last verified

Apr, 2026

Keywords

  • pregnancy
  • postpartum
  • sleep
  • worry
  • rumination

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-09. This information was provided to ClinicalTrials.gov by Henry Ford Health System on 2026-04-17.