Sleep to Reduce Incident Depression Effectively in Peripartum

Description

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

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Study Overview

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Study Details

Study overview

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.

Sleep to Reduce Incident Depression Effectively in Peripartum

Sleep to Reduce Incident Depression Effectively in Peripartum

Condition
Insomnia
Intervention / Treatment

-

Contacts and Locations

Novi

Henry Ford Medical Center, Novi, Michigan, United States, 48377

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

For general information about clinical research, read Learn About Studies.

Eligibility 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.
  • 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.).

Ages Eligible for Study

18 Years to

Sexes Eligible for Study

FEMALE

Accepts Healthy Volunteers

No

Collaborators and Investigators

Henry Ford Health System,

David A Kalmbach, PhD, PRINCIPAL_INVESTIGATOR, Henry Ford Health

Study Record Dates

2028-02-29