Ignite Creation Date:
2024-05-06 @ 10:49 AM
Last Modification Date:
2024-10-26 @ 12:35 PM
Study NCT ID:
NCT03354351
Status:
UNKNOWN
Last Update Posted:
2017-11-28
First Post:
2017-11-16
Brief Title:
Comorbid Mental Disease and Heart Disease in Men
Sponsor:
Universite de Moncton
Organization:
Universite de Moncton
Study Overview
Official Title:
Mind the Heart Best Practices for Prevention Early Identification and Treatment of Mood and Anxiety Disorders in Men With Heart Disease
Status:
UNKNOWN
Status Verified Date:
2017-11
Last Known Status:
NOT_YET_RECRUITING
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
MindTheHeart
Brief Summary:
Mood disorders anxiety disorders and trauma-related stress MDADTRS are common among men particularly those suffering from heart disease HD MDADTRS 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 MDADTRS 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 MDADTRS in men living with HD This Participatory Action Research aims to implement a stepped-care model for MDADTRS 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 overarching goal of this interventional program is therefore to prevent early detect and treat MDADTRS in men living with HD This Participatory Action Research aims to implement a stepped-care model for MDADTRS 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
Detailed Description:
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 Therapy1 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 68 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 mens 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 MDADTRS3 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 MDADTRS 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 mens mental health quality of life and physical health over the long term along with their life expectancy Indeed the occurrence of MDADTRS 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 STEMI5 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 individuals 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 eg intimate partner7-12 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 relationships1314 This can be especially problematic for men because they tend to become more intensely physiologically aroused eg 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 homeostasis16-18Unfortunately this type of stonewalling15 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 TRS2223 Patients with MDADTRS 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 MDADTRS
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 treatmentscare of MDADTRS 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 MDADTRS 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 eg goal-oriented focus with specific and attainable objectives34 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 eg identifying and discussing feelings considering the intra- and interpersonal impact of ones 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 problems436 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 MDADTRS A notable exception to this is IPT mentioned earlier Furthermore to the investigators knowledge IPT has not been applied to cardiac patients with MDADTRS 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 efficacy26333738 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 MDADTRS as they recover from HD These include a focus on the intra- and interpersonal skills known to coincide with psychological health eg 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 eg task-focused approach appropriate rationale
Stepped-care models have been applied elsewhere for MDADTRS 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 globally4344 and their adaptation deemed as cost-effective45-47
The MDADTRS stepped-care intervention proposed in this study will contribute to adopt men-sensitive interventions and preventive approaches informationeducation and early detection and to emphasize the link between HD and mens 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 MDADTRS
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
Background information In 2012 the Canadian Institute for Health Information estimated that 68 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 mens 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 MDADTRS3 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 MDADTRS 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 mens mental health quality of life and physical health over the long term along with their life expectancy Indeed the occurrence of MDADTRS 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 STEMI5 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 individuals 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 eg intimate partner7-12 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 relationships1314 This can be especially problematic for men because they tend to become more intensely physiologically aroused eg 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 homeostasis16-18Unfortunately this type of stonewalling15 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 TRS2223 Patients with MDADTRS 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 MDADTRS
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 treatmentscare of MDADTRS 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 MDADTRS 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 eg goal-oriented focus with specific and attainable objectives34 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 eg identifying and discussing feelings considering the intra- and interpersonal impact of ones 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 problems436 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 MDADTRS A notable exception to this is IPT mentioned earlier Furthermore to the investigators knowledge IPT has not been applied to cardiac patients with MDADTRS 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 efficacy26333738 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 MDADTRS as they recover from HD These include a focus on the intra- and interpersonal skills known to coincide with psychological health eg 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 eg task-focused approach appropriate rationale
Stepped-care models have been applied elsewhere for MDADTRS 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 globally4344 and their adaptation deemed as cost-effective45-47
The MDADTRS stepped-care intervention proposed in this study will contribute to adopt men-sensitive interventions and preventive approaches informationeducation and early detection and to emphasize the link between HD and mens 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 MDADTRS
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
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None