Mind the Heart: Best Practices for Prevention, Early Identification and Treatment of Mood and Anxiety Disorders in Men With Heart Disease
试验速览
- 阶段
- 不适用
- 入组人数
- 3,000
- 主要终点
- Change from Baseline PHQ9 at 12 months
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Observational
- 观察模型
- Ecologic Or Community
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 95 Years(Adult, Older Adult)
- 性别
- Male
- 接受健康志愿者
- 否
入选标准
- •New Brunswick, Ontario and Quebec sites:
- •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.
- •able to speak or write in English or French
- •with an identified treating health professional (cardiologist, family doctor or nurse practitioner).
- •able to attend 8 weekly sessions if qualifies for step 2;
- •available for at least one year of follow-up.
- •New-Brunswick site only:
- •Surgery patients (surgery in the last three months) will also be included (CABG, Percutaneous valve, Valve, Valve/Graft, Cardioverter (pacemaker), ...)
- •Congestive heart failure : patients with NYHA Class III or NYHA Class IV.
排除标准
- •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.
结局指标
主要结局
Change from Baseline PHQ9 at 12 months
时间窗: Baseline, 3 months, 6 months, 9 months and 12 months
Questionnaire for Depression Scoring: Minimal depression (0-4); Mild depression (5-9); Moderate depression (10-14); Moderately severe depression (15-19); Severe depression (20-27)
Change from Baseline DASS-21 at 12 months
时间窗: Baseline, 3 months, 6 months, 9 months and 12 months
set of three self-report scales designed to measure the emotional states of depression, anxiety and stress. Each of the three DASS-21 scales contains 7 items, divided into subscales with similar content. The depression scale assesses dysphoria, hopelessness, devaluation of life, self-deprecation, lack of interest / involvement, anhedonia and inertia. The anxiety scale assesses autonomic arousal, skeletal muscle effects, situational anxiety, and subjective experience of anxious affect. The stress scale is sensitive to levels of chronic nonspecific arousal. It assesses difficulty relaxing, nervous arousal, and being easily upset / agitated, irritable / over-reactive and impatient. Scores for depression, anxiety and stress are calculated by summing the scores for the relevant items.
Change from Baseline IES-R at 12 months
时间窗: Baseline, 3 months, 6 months, 9 months and 12 months
The IES-R is a 22-item self-report measure that assesses subjective distress caused by traumatic events.Items are rated on a 5-point scale ranging from 0 ("not at all") to 4 ("extremely"). The IES-R yields a total score (ranging from 0 to 88) and subscale scores can also be calculated for the Intrusion, Avoidance, and Hyperarousal subscales.
次要结局
- Change from Baseline CSI-32 at 12 months(Baseline, 3 months, 6 months, 9 months and 12 months)
- Change from Baseline CMNI-22 at 12 months(Baseline, 3 months, 6 months, 9 months and 12 months)
研究者
Jalila Jbilou
Associate professor
Universite de Moncton
