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NCT03596879: PPD
Insomnia and Rumination in Late Pregnancy and the Risk for Postpartum Depression
NA trial testing dCBTI in Insomnia in 91 participants. Completed in 31 July 2019.
31 July 2019
Quick facts
| Lead sponsor | Henry Ford Health System |
|---|---|
| Phase | NA |
| Status | Completed |
| Study type | INTERVENTIONAL |
| Allocation | randomized |
| Design | parallel |
| Masking | none |
| Primary purpose | treatment |
| Enrollment | 91 |
| Start date | 18 July 2018 |
| Primary completion | 31 July 2019 |
| Estimated completion | 31 July 2019 |
| Sites | 1 location across United States |
Drugs / interventions tested
- dCBTI
- Sleep Education
Conditions studied
- Insomnia — all drugs for Insomnia →
- Post Partum Depression — all drugs for Post Partum Depression →
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):
-
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 -
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 -
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 -
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 -
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
Verify or expand the search:
- PubMed search for NCT03596879
- Europe PMC full search
- ASCO Meeting Library
- ESMO Meeting Library
- bioRxiv preprints
- medRxiv preprints
- Google Scholar
Related trials
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Currently open trials in the same condition.
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- NCT06348082 — Project Women's Insomnia Sleep Health Equity Study (WISHES) · NA · recruiting
Other Henry Ford Health System trials
Trials by the same sponsor.
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- NCT06670287 — The Use of Multiple Sensors to Track Sleep in Nightshift Workers · NA · recruiting
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- NCT07530172 — Radioembolization Versus External Radiation Therapy · Phase 2 · recruiting
Verify against primary sources
- ClinicalTrials.gov — authoritative US registry record
- WHO ICTRP — international registry index
- EU Clinical Trials Register
- Sponsor press releases (Google)
- Trial protocol + status: ClinicalTrials.gov NCT03596879 (US National Library of Medicine, public domain)
- Publications: Europe PMC API search by NCT ID, retrieved 10 June 2026
- Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
- Sponsor: as reported to ClinicalTrials.gov by Henry Ford Health System
- Last refreshed: 5 December 2019
Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT03596879.
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