Comorbid Mental Disease and Heart Disease in Men

NCT03354351 · Status: UNKNOWN · Type: OBSERVATIONAL · Enrollment: 3000

Last updated 2017-11-28

No results posted yet for this study

Summary

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.

Conditions

  • Acute Coronary Syndrome
  • Depressive Disorder
  • Anxiety Disorders
  • Stress Disorders, Post-Traumatic

Interventions

BEHAVIORAL

Stepped-care model

The intervention proposed in this study is a stepped-care model (comprising 3 steps) integrating cognitive-behavioural therapy or trauma-focused therapy and emotion-focused therapy that involves matching individuals to the most appropriate level of care, based on their specific needs . When patients do not show improvement they move to higher, more intensive levels of care.

Sponsors & Collaborators

  • Movember Foundation

    collaborator OTHER
  • New Brunswick Health Research Foundation

    collaborator OTHER
  • Universite de Moncton

    lead OTHER

Principal Investigators

  • Jalila Jbilou, MD, PhD · Universite de Moncton

Eligibility

Min Age
18 Years
Max Age
95 Years
Sex
MALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2017-12-01
Primary Completion
2018-12-31
Completion
2019-12-31

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03354351 on ClinicalTrials.gov