Comorbid Mental Disease and Heart Disease in Men
Comorbid Mental Disease and Heart Disease in Men
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.
The intervention proposed in this study is a stepped-care model comprised of three steps. The
 intensity of the intervention increases for participants with each of the following steps: 1)
 psychoeducation, 2) group therapy and 3) individual therapy. Recent evidence has shown the
 need for more tailored assessment and treatment methods for men suffering from depression as
 well as evidence showing the effectiveness of EFT (Emotionally-Focused Therapy)1. As such,
 the stepped-care model approach will be based on cognitive-behaviour therapy (CBT) and
 Emotionally-Focused Therapy (EFT). The research design is based on a quasi-experimental
 paradigm and a prospective observational cohort study.

 Background information In 2012, the Canadian Institute for Health Information estimated that
 6.8 million Canadians age 20 to 74 are affected by the following chronic conditions heart
 disease, high blood pressure, diabetes, asthma, and chronic obstructive pulmonary disease.
 Strikingly, nearly 40% more men than women are likely to be hospitalized for all types of
 heart disease (HD) combined2. Mental health and physical health are fundamentally linked. It
 is three times more likely that a person with HD will experience depression when compared to
 people without HD2. Research on men's mental health in the context of HD, specifically in
 acute coronary syndrome (ACS), reveals an important relationship between HD and mood
 disorders, anxiety disorders, and trauma-related stress in men (MD/AD/TRS)3. Co-existing HD
 and mental illness contribute to worse health status and higher health care utilization
 rates3. This is problematic because men underuse mental health services and health services
 in general4. The principal reasons evoked to explain this are the lack of "male-friendly"
 health services, the functional view that men have of their bodies, and their perception of
 healthcare services as occasional "fix-it" cures4. Thus, while men appear to be at high risk
 for HD and for the spectrum of MD/AD/TRS that often accompany it and slow the rehabilitation
 from ACS, they are unlikely to receive preventative services, to seek and to receive
 appropriate timely interventions for their psychological distress and mental illness. This in
 turn, can jeopardize men's mental health, quality of life and physical health over the long
 term, along with their life expectancy. Indeed, the occurrence of MD/AD/TRS has been shown to
 impact the prognosis of ACS patients.

 In the context of this study an Acute coronary syndrome (ACS) encompasses multiple heart
 diseases having symptoms consistent with acute myocardial ischemia, including unstable angina
 and myocardial infarctions (MI) ("heart attacks") such as non-ST-segment elevation myocardial
 infarction (NSTEMI) and ST-segment elevation myocardial infarction (STEMI)5. On the other
 hand, Mood disorder or depressive disorders (MD) includes a variety of depressive conditions
 that mainly cause an individual to not function normally from a mental and physical
 standpoint. These conditions all show symptoms of sadness, emptiness and irritable mood6.
 Anxiety disorders (AD) consist of the anticipation of future threats, which cause an
 individual to be overly cautious or avoidant and result in such actions as misguided or
 anticipatory muscle tension in normal-considered situations6. Trauma-related stress (TRS)
 describes a condition where the individual's exposure to an event has caused unusual,
 physical or mental, stress or trauma. The aftermath of these events can vary; with some
 having the individual experiences anxiety and fear, but more often they will show a hedonic,
 dysphoric, dissociative and aggressive symptoms6.

 Relevant Literature and Data The psychological effects of HD are seen at the patient level
 and their family (e.g. intimate partner)7-12. HD is related to decrease in sexual activity
 and sexual satisfaction, decrease in effective interpersonal communication, and increase in
 the amount and intensity of conflict in couple relationships13,14. This can be especially
 problematic for men, because they tend to become more intensely physiologically aroused
 (e.g., increase in blood pressure, cardiac reactivity, and limbic activation) for more
 extended periods of time during and after conflicts with their partners than do women15,
 which tends to lead them to shut down emotionally and to shut out their relationship partner
 in an attempt to re-establish psychological and physiological homeostasis16-18.Unfortunately,
 this type of "stonewalling"15 behaviour usually only serves to exacerbate couple conflict and
 leads to distressed conjugal relationships16-18. Clinically significant symptoms of
 depression and anxiety are known correlates of conjugal distress19-21. Furthermore, emotional
 isolation is also a known risk factor for the development of TRS22,23. Patients with
 MD/AD/TRS are at greater risk (two-fold) of major adverse cardiac events than those
 without24; and at risk of recurrent HD and mortality25. All of this may contribute to poorer
 prognosis of ACS patients with MD/AD/TRS.

 Despite findings from some small-scale studies that indicate positive effects of
 psychotherapy and pharmacological therapy on symptoms of depression and anxiety in the
 context of HD26-28, the results of large controlled trials are equivocal. The Enhancing
 Recovery in Coronary HD Patients (ENRICHD) study investigated MD, HD, social support and
 CBT29-32. Their finding showed that CBT helped to reduce symptoms of depression in MI
 patients in short term but the benefits waned after 30 months. Similarly, the Cardiac
 Randomized Evaluation of Antidepressant and Psychotherapy Efficacy (CREATE) study suggested
 that 12 weeks of Interpersonal Therapy (IPT) did not add to the effects of clinical
 management on depression in cardiac patients when combined with the antidepressant
 citalopram33. The psychological treatments that have been used to date thus appear to be
 lacking for cardiac patients with depression, which emphasizes the need for the development
 of ones that will have the desired effects on their psychological symptoms. Aside from the
 handful of studies cited above, published reports of treatments/care of MD/AD/TRS in the
 context of HD are virtually nonexistent. Thus far, all of the research in this area has
 focused on generic treatments for men and women that might neglect the specific needs or
 tendencies of either gender in terms of mental-health treatment.

 For aforementioned reasons, ensuring that men are properly informed, screened, and treated
 for MD/AD/TRS in the context of HD is essential. It is also imperative that the preventive
 approaches and the treatments they receive be tailored to their particular needs (e.g.
 goal-oriented focus with specific and attainable objectives)34. As previous literature
 pointed out, "The rationale behind the development of male sensitive approaches is that men
 generally have a harder time engaging in the activities germane to psychotherapy (e.g.,
 identifying and discussing feelings, considering the intra- and interpersonal impact of one's
 own behaviour and that of others, showing vulnerability, asking for help) than do women, for
 a host of reasons related to both biology and socialization ." Men are significantly less
 likely than women to seek any kind of help for common mental-health problems4,36. Most of the
 psychological services routinely offered tend to focus predominantly on symptom-management,
 with little attention to the interpersonal connections that attenuate the loneliness and
 isolation that contribute to MD/AD/TRS. A notable exception to this is IPT mentioned earlier.
 Furthermore, to the investigators knowledge, IPT has not been applied to cardiac patients
 with MD/AD/TRS, and it appears to be less effective for patients with little or no social
 support or with dysfunctional conjugal relationships26. Recognition of the importance of
 interpersonal relationships for mental health has led a handful of clinical researchers to
 integrate relational components into their treatments for depression, anxiety, and comorbid
 HD and to test their efficacy26,33,37,38. However, there has not yet been, to the
 investigators knowledge, any systematic attempt to tailor and apply relationship-focused
 treatments to the needs of men suffering from MD/AD/TRS as they recover from HD. These
 include a focus on the intra- and interpersonal skills known to coincide with psychological
 health (e.g., awareness and integration of primary affect into daily interactions in order to
 meet socio-affective needs, realistic thinking, engagement in rewarding behaviours) and
 presentation of these skills in ways that will resonate with male patients (e.g.,
 task-focused approach, appropriate rationale).

 Stepped-care models have been applied elsewhere for MD/AD/TRS treatment with general success
 and acceptability. Studies have shown that the stepped-care implementation was received
 positively in primary care settings39. It was also shown to be effective in reducing symptoms
 and improving functioning among TRS patients40. According to the literature, the stepped care
 model has also been used with cardiac patients and was acceptable, effective and
 accessible41.

 Clinical relevance of the project Currently, in the province of New Brunswick, there a few
 services offered or follow-ups available for ACS patients in relation to their mental health.
 Some cardiac rehabilitation centers in the province offer access to psychological services to
 ACS patients, but these are very limited compared to more intensive services such as
 stepped-care models. These services include access to information on depression and a more
 thorough Cardiac Wellness Program with access to a psychologist for patients who wish to
 pursue their rehabilitation42. In the past few decades, implementation of stepped-care models
 for the treatment of mood disorders have been seen globally43,44 and their adaptation deemed
 as cost-effective45-47.

 The MD/AD/TRS stepped-care intervention proposed in this study will contribute to adopt
 men-sensitive interventions and preventive approaches (information/education and early
 detection) and to emphasize the link between HD and men's relationships and interpersonal
 support by means of including identified significant people in their lives for their
 treatment. Modifications to the stepped-care model will be integrated based on findings from
 the qualitative study in phase 1 of the project which encompassed focus groups with men and
 interviews with health professionals. Some of these modifications include utilizing language
 that is men sensitive, giving a choice to men as to whether they would like to include their
 partners in therapy and providing training for therapists on the stepped care model.

 Objectives of the Phase 2 of the study Primary Objectives The primary objectives of this
 observational study is to assess the feasibility, acceptability and efficacy of the
 stepped-care model and thus to identify predictors of utilization, compliance and clinical
 trajectory of men following an ACS, experiencing or not a common mental illness (MD/AD/TRS).

 Secondary Objectives

 In addition, the study secondary objectives are:

 -  Improve the utilization of cardiac rehabilitation programs among men post-ACS.

 -  Assess changes of men perceptions towards masculinity and their relationship to their
 partners.

 -  Develop recommendations to support implementation and scaling-up the intervention in the
 province.
Inclusion Criteria:

 -  New Brunswick, Ontario and Quebec sites:

 1. men with a diagnosis of ACS (Acute cardiac syndrome) : myocardial infarction such
 as ST-segment elevation myocardial infarction (STEMI), non-ST-segment elevation
 myocardial infarction (NSTEMI), or unstable angina, or angioplasty with or
 without a stent or coronary bypass in the last 3 months.

 2. able to speak or write in English or French

 3. with an identified treating health professional (cardiologist, family doctor or
 nurse practitioner).

 4. able to attend 8 weekly sessions if qualifies for step 2;

 5. available for at least one year of follow-up.

 -  New-Brunswick site only:

 1. Surgery patients (surgery in the last three months) will also be included (CABG,
 Percutaneous valve, Valve, Valve/Graft, Cardioverter (pacemaker), …)

 2. Congestive heart failure : patients with NYHA Class III or NYHA Class IV.

 Exclusion Criteria:

 -  Abuse of any substance in the past 12 months such as alcohol, cannabis, drugs as
 screened by the Simple Screening Instrument for Substance Abuse;

 -  Self-reported personal history of psychotic disorders or bipolar disorders (i.e.
 schizophrenia, paranoia, personality disorders

 -  Recently (3 months or less) started on psychotherapy or pharmacological treatment of
 MD/AD/TRS.