RECRUITING

Sleep to Reduce Incident Depression Effectively in Peripartum

Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

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.

Official Title

Sleep to Reduce Incident Depression Effectively in Peripartum

Quick Facts

Study Start:2024-12-10
Study Completion:2028-02-29
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:RECRUITING

Study ID

NCT06430333

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.

Ages Eligible for Study:18 Years
Sexes Eligible for Study:FEMALE
Accepts Healthy Volunteers:No
Standard Ages:ADULT, OLDER_ADULT
Inclusion CriteriaExclusion Criteria
  1. 1. Singleton pregnancy, gestational week 14-31 at screening.
  2. 2. DSM-5 Insomnia Disorder (≥1 month duration).
  3. 3. Insomnia Severity Index (ISI) score ≥ 11.
  4. 4. Edinburgh Postnatal Depression Scale score\<13 at screening.
  5. 5. No current DSM-5 Major Depression.
  6. 6. Reliable internet access for treatment and assessments.
  7. 7. Not currently engaged in therapy for major depression or insomnia disorder.
  8. 8. Age 18 years or older.
  1. 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. 2. Active suicidal intent.
  3. 3. Night or rotating shift work, anticipated travel across time 3 or more time zones in the 2 months after baseline screening.
  4. 4. Untreated RLS (treated RLS is OK).
  5. 5. Excessive daytime sleepiness; Epworth Sleepiness Scale\>15.
  6. 6. Uncontrolled sleep or mental disorder inappropriate or unsafe for sleep restriction (narcolepsy, bipolar, epilepsy, etc.).

Contacts and Locations

Study Contact

David A Kalmbach, PhD
CONTACT
248-325-3938
dkalmba1@hfhs.org
Christopher L Drake, PhD
CONTACT
248-344-6672
cdrake1@hfhs.org

Principal Investigator

David A Kalmbach, PhD
PRINCIPAL_INVESTIGATOR
Henry Ford Health

Study Locations (Sites)

Henry Ford Medical Center
Novi, Michigan, 48377
United States

Collaborators and Investigators

Sponsor: Henry Ford Health System

  • David A Kalmbach, PhD, PRINCIPAL_INVESTIGATOR, Henry Ford Health

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2024-12-10
Study Completion Date2028-02-29

Study Record Updates

Study Start Date2024-12-10
Study Completion Date2028-02-29

Terms related to this study

Keywords Provided by Researchers

  • pregnancy
  • postpartum
  • sleep
  • worry
  • rumination

Additional Relevant MeSH Terms

  • Insomnia
  • Depression