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NCT03596879: PPD

Insomnia and Rumination in Late Pregnancy and the Risk for Postpartum Depression

Completed NA Last updated 5 December 2019
What this trial tests

NA trial testing dCBTI in Insomnia in 91 participants. Completed in 31 July 2019.

Timeline
18 July 2018
Primary endpoint
31 July 2019
31 July 2019

Quick facts

Lead sponsorHenry Ford Health System
PhaseNA
StatusCompleted
Study typeINTERVENTIONAL
Allocationrandomized
Designparallel
Maskingnone
Primary purposetreatment
Enrollment91
Start date18 July 2018
Primary completion31 July 2019
Estimated completion31 July 2019
Sites1 location across United States

Drugs / interventions tested

Conditions studied

Sponsor

Henry Ford Health System — full company profile →

Who can join

18 and older, female only, with Insomnia or Post Partum Depression. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

The primary objective of the proposed research is to determine whether prenatal insomnia and ruminative thinking predict severity of postpartum depression (PPD) symptoms. Additionally, the investigators will also determine the effectiveness of digital/internet-based Cognitive Behavioral Therapy for Insomnia (dCBTI) in reducing the risk for PPD.

Publications & conference data

5 peer-reviewed publications reference this trial (live from Europe PMC):

  1. A randomized controlled trial of digital cognitive behavioral therapy for insomnia in pregnant women.
    Kalmbach DA, Cheng P, O'Brien LM, Swanson LM, et al · · 2020 · cited 93× · PMID 32559716 · DOI 10.1016/j.sleep.2020.03.016
  2. Depression and suicidal ideation in pregnancy: exploring relationships with insomnia, short sleep, and nocturnal rumination.
    Kalmbach DA, Cheng P, Ong JC, Ciesla JA, et al · · 2020 · cited 68× · PMID 31710876 · DOI 10.1016/j.sleep.2019.07.010
  3. Mindfulness and nocturnal rumination are independently associated with symptoms of insomnia and depression during pregnancy.
    Kalmbach DA, Roth T, Cheng P, Ong JC, et al · · 2020 · cited 35× · PMID 32146168 · DOI 10.1016/j.sleh.2019.11.011
  4. Examining Patient Feedback and the Role of Cognitive Arousal in Treatment Non-response to Digital Cognitive-behavioral Therapy for Insomnia during Pregnancy.
    Kalmbach DA, Cheng P, Roth T, Swanson LM, et al · · 2022 · cited 25× · PMID 33719795 · DOI 10.1080/15402002.2021.1895793
  5. Racial disparities in treatment engagement and outcomes in digital cognitive behavioral therapy for insomnia among pregnant women.
    Kalmbach DA, Cheng P, Reffi AN, Seymour GM, et al · · 2023 · cited 24× · PMID 36456448 · DOI 10.1016/j.sleh.2022.10.010

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Other trials of dCBTI

Trials testing the same drug.

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Other Henry Ford Health System trials

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