Last reviewed · How we verify
NCT03354351: MindTheHeart
Comorbid Mental Disease and Heart Disease in Men
trial testing Stepped-care model in Acute Coronary Syndrome in 3,000 participants. Status unknown.
31 December 2018
Quick facts
| Lead sponsor | Universite de Moncton |
|---|---|
| Status | Status unknown |
| Study type | OBSERVATIONAL |
| Enrollment | 3,000 |
| Start date | 1 December 2017 |
| Primary completion | 31 December 2018 |
| Estimated completion | 31 December 2019 |
Drugs / interventions tested
- Stepped-care model
Conditions studied
- Acute Coronary Syndrome — all drugs for Acute Coronary Syndrome →
- Depressive Disorder — all drugs for Depressive Disorder →
- Anxiety Disorders — all drugs for Anxiety Disorders →
- Stress Disorders, Post-Traumatic — all drugs for Stress Disorders, Post-Traumatic →
Sponsor
Universite de Moncton
Who can join
Adults 18 to 95, male only, with Acute Coronary Syndrome or Depressive Disorder. Patients with the condition only — healthy volunteers not accepted.
Sponsor's own description
Mood disorders, anxiety disorders, and trauma-related stress (MD\\AD\\TRS) are common among men, particularly those suffering from heart disease (HD). MD\\AD\\TRS are significantly related to exacerbation of HD symptoms that often lead to death. Unfortunately, men are significantly less likely than women to seek and receive appropriate treatment for their mental health issues including MD\\AD\\TRS. Furthermore, there is little literature about the use of the stepped care model in the Canadian setting. The overarching goal of this interventional program is therefore to prevent, early detect and treat MD\\AD\\TRS in men living with HD. This Participatory Action Research aims to implement a stepped-care model for MD\\AD\\TRS in men in New Brunswick, Ontario, and quebec. The second phase of the project proposes a quantitative study that will consist of testing the effectiveness and acceptability (by the men and the involved health professionals) of the stepped-care model. It will offer to post ACS-males a mental health related component presently not available in the typical services of the NB health system. Data will be collected at baseline (0 month) and at four follow-up (each 3-months) sessions to manage the progress of each participant throughout their 12-month journey in the study. Typical sociodemographic data will be collected, along with a questionnaire on Masculinity Norms, Couples Satisfaction (when applicable), and four mental health assessment tools.
Publications & conference data
1 peer-reviewed publication reference this trial (live from Europe PMC):
-
Relationship satisfaction and psychological wellbeing in men having participated in the MindTheHeart® psychoeducation intervention after an acute coronary syndrome.
Barriault S, Jbilou J, Charbonneau A, Greenman PS, et al · · 2023 · cited 1× · PMID 37273832 · DOI 10.1177/20551029231179165
Verify or expand the search:
- PubMed search for NCT03354351
- Europe PMC full search
- ASCO Meeting Library
- ESMO Meeting Library
- bioRxiv preprints
- medRxiv preprints
- Google Scholar
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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 NCT03354351 (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 Universite de Moncton
- Last refreshed: 28 November 2017
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/NCT03354351.
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing