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NCT03803189: P3MH
Proactive, Personalized Postpartum Mental Healthcare
NA trial testing Usual care plus eToolkit in Postpartum Depression in 130 participants. Completed in 24 April 2021.
24 April 2021
Quick facts
| Lead sponsor | Women's College Hospital |
|---|---|
| Phase | NA |
| Status | Completed |
| Study type | INTERVENTIONAL |
| Allocation | randomized |
| Design | parallel |
| Masking | double |
| Primary purpose | health services research |
| Enrollment | 130 |
| Start date | 14 March 2019 |
| Primary completion | 24 April 2021 |
| Estimated completion | 24 April 2021 |
| Sites | 2 locations across Canada |
Drugs / interventions tested
- Usual care plus eToolkit
Conditions studied
- Postpartum Depression — all drugs for Postpartum Depression →
- Postpartum Blues — all drugs for Postpartum Blues →
- Postpartum Anxiety — all drugs for Postpartum Anxiety →
- Postpartum Mood Disorder — all drugs for Postpartum Mood Disorder →
Sponsor
Women's College Hospital
Who can join
18 and older, any sex, with Postpartum Depression or Postpartum Blues. Patients with the condition only — healthy volunteers not accepted.
Sponsor's own description
Mental health symptoms - especially depression and anxiety - are very common in new parents, affecting close to 20% of mothers and at least 10% of fathers. When such symptoms progress to severe levels, they can be more difficult to treat. Early identification of symptoms and prompt treatment are ideal. Despite broad awareness that mental health symptoms in new parents are common, few systems are in place to automatically assess and monitor such symptoms. Evidence-based symptom surveys that can identify parents at risk for postpartum mental health disorders exist, and effective medication and non-medication treatment options are available. Yet, most primary care settings do not have systems in place to ensure that parents with mental health problems (and especially fathers) are identified and treated. This study will use a digital application with a customized website, electronic medical record and email integration to engage parents in assessing their mental health symptoms within weeks of the birth of their new baby. Electronic symptom surveys, sent on behalf of the family doctor, will be used to support proactive, personalized postpartum mental healthcare (P3MH). Responses will be used to enable a tailored care plan for the patient, including advice about options for referrals, treatment, and local community-based psycho-educational and/or social supports. This eHealth intervention includes a web-based application for parents and seamless integration in the EMR, so that when the family doctor sees the patient in clinic, relevant information is ready to be discussed. In this study, a co-design process will be carried with patients and health professionals to refine this eHealth intervention, and determine the usability, user experience, and perceived value of this process in terms of whether it enables mental health symptoms to be caught early and managed in the best way possible for each parent. The procedures will also be piloted for a future large-scale evaluation.
Publications & conference data
No peer-reviewed publications indexed yet for this trial. Completed trials usually publish results within 12-18 months.
Verify or expand the search:
- PubMed search for NCT03803189
- Europe PMC full search
- ASCO Meeting Library
- ESMO Meeting Library
- bioRxiv preprints
- medRxiv preprints
- Google Scholar
Related trials
Other recruiting trials for Postpartum Depression
Currently open trials in the same condition.
- NCT07398469 — A Long-Term Study of Patient-Reported Changes in Postpartum Depression Symptoms in People Starting Zuranolone · recruiting
- NCT06442774 — MamaConecta: Digital Tool for Maternal Mental Health · NA · recruiting
- NCT06545760 — Admission to Kangaroo Mother Care (KMC) Ward and Maternal Postpartum Depression · NA · recruiting
- NCT05763537 — Understanding the Role of Doulas in Supporting People With PMADs · NA · recruiting
- NCT06462638 — COntact RElationship in Neonatal Intensive Care Unit · recruiting
Other Women's College Hospital trials
Trials by the same sponsor.
- NCT07262008 — Sustained Mood Improvement With Laughing Gas Exposure · Phase 3 · not yet recruiting
- NCT07066631 — The Pregnancy and Postpartum Mental Health Optimization Virtual Intervention Network · NA · recruiting
- NCT06852339 — Evaluating the EAPOC-COPD System · NA · not yet recruiting
- NCT07027852 — My Lung Health Coach-A Virtual COPD Self-management Support Program Integrated Into the Electronic Patient Record · NA · recruiting
- NCT06462391 — Adapting and Piloting Acceptance and Commitment Therapy (ACT) for Severe Premenstrual Mood Symptoms · NA · active not 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 NCT03803189 (US National Library of Medicine, public domain)
- Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
- Sponsor: as reported to ClinicalTrials.gov by Women's College Hospital
- Last refreshed: 5 October 2021
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/NCT03803189.
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing