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Trial record 38 of 279 for:    Best Disease

Comorbid Mental Disease and Heart Disease in Men (MindTheHeart)

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ClinicalTrials.gov Identifier: NCT03354351
Recruitment Status : Not yet recruiting
First Posted : November 27, 2017
Last Update Posted : November 28, 2017
Sponsor:
Collaborators:
Movember Foundation
New Brunswick Health Research Foundation
Information provided by (Responsible Party):
Jalila Jbilou, Universite de Moncton

Brief 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.


Condition or disease Intervention/treatment
Acute Coronary Syndrome Depressive Disorder Anxiety Disorders Stress Disorders, Post-Traumatic Behavioral: Stepped-care model

  Show Detailed Description

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Study Type : Observational
Estimated Enrollment : 3000 participants
Observational Model: Ecologic or Community
Time Perspective: Prospective
Official Title: Mind the Heart: Best Practices for Prevention, Early Identification and Treatment of Mood and Anxiety Disorders in Men With Heart Disease
Estimated Study Start Date : December 1, 2017
Estimated Primary Completion Date : December 31, 2018
Estimated Study Completion Date : December 31, 2019

Resource links provided by the National Library of Medicine


Group/Cohort Intervention/treatment
NB-Group
Stepped-care model comprising a hierarchy of interventions, from the least to the most intensive, matched to the cardiac man's needs. The model involves three steps: Step 1 (therapist-guided and self-guided 3-session psychoeducational program), Step 2 (Group sessions involving care partners), and Step 3 (individual or dyadic (patient and care Partner) sessions. As such, if following Step 1, the mental-health symptoms of men with HD do not sufficiently subside, as identified by the screening tests, participants will qualify for Step 2. Following Step 2, men who continue to meet criteria for a clinically significant mood, anxiety, or post-traumatic stress disorder on the screening tests (PHQ9, MRDS, DASS 21, IES-R, CIS), will be invited to receive services at Step 3.
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.
Other Name: MindTheHeart

ON-Group
Stepped-care model where men will need to follow a sequential treatment (Step 1 (self-guided), Step 2 (Group sessions), and Step 3 (individual or couple sessions). As such, if following Step 1, the mental-health symptoms of men with HD do not sufficiently subside, as identified by the screening tests, participants will qualify for Step 2. Following Step 2, men who continue to meet criteria for a clinically significant mood, anxiety, or post-traumatic stress disorder on the screening tests (PHQ9, MRDS, DASS 21, IES-R, CIS), will be invited to receive services at Step 3.
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.
Other Name: MindTheHeart

QC-Group
Standard Stepped-care model where men will need to follow a sequential treatment (Step 1 (self-guided), Step 2 (Group sessions), and Step 3 (individual or couple sessions). As such, if following Step 1, the mental-health symptoms of men with HD do not sufficiently subside, as identified by the screening tests, participants will qualify for Step 2. Following Step 2, men who continue to meet criteria for a clinically significant mood, anxiety, or post-traumatic stress disorder on the screening tests (PHQ9, MRDS, DASS 21, IES-R, CIS), will be invited to receive services at Step 3.
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.
Other Name: MindTheHeart




Primary Outcome Measures :
  1. Change from Baseline PHQ9 at 12 months [ Time Frame: 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)

  2. Change from Baseline DASS-21 at 12 months [ Time Frame: 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.

  3. Change from Baseline IES-R at 12 months [ Time Frame: 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.


Secondary Outcome Measures :
  1. Change from Baseline CSI-32 at 12 months [ Time Frame: Baseline, 3 months, 6 months, 9 months and 12 months ]
    A 32-item scale designed to measure one's satisfaction in a relationship. The scale has a variety of items with different response scales and formats. The authors have also specified that the scale safely be shrunk to either a 16-item format or even a 4-item format depending on a researcher's needs.

  2. Change from Baseline CMNI-22 at 12 months [ Time Frame: Baseline, 3 months, 6 months, 9 months and 12 months ]
    Conformity to Masculine Norms Inventory-Abbreviated version. Self-descriptive statements that measure individual behaviors, attitudes, and conformity to an assortment of dominant masculine norms in the United States.


Other Outcome Measures:
  1. Change from Baseline GAD-7 at 12 months [ Time Frame: Baseline, 3 months, 6 months, 9 months and 12 months ]
    The GAD-7 score is calculated by assigning scores of 0, 1, 2, and 3, to the response categories of 'not at all', 'several days', 'more than half the days', and 'nearly every day', respectively, and adding together the scores for the seven questions.

  2. Change from Baseline MDRS-22 at 12 months [ Time Frame: Baseline, 3 months, 6 months, 9 months and 12 months ]
    Male Depression Risk Scale (MDRS-22) is a 22-item measure that employs a 7-point rating scale (0 = not at all, 7 = almost always).



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   18 Years to 95 Years   (Adult, Older Adult)
Sexes Eligible for Study:   Male
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Male inpatients of cardiology departments, clients of cardiac rehabilitation programs and patients refered by their cardiologist or family doctor.
Criteria

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03354351


Contacts
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Contact: Jalila Jbilou, MD, PhD 506-858-4931 jalila.jbilou@umoncton.ca
Contact: Rana Sughayar, MSc 506-858-4721 rana.sughayar@umoncton.ca

Sponsors and Collaborators
Universite de Moncton
Movember Foundation
New Brunswick Health Research Foundation
Investigators
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Principal Investigator: Jalila Jbilou, MD, PhD Universite de Moncton

Additional Information:
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Responsible Party: Jalila Jbilou, Associate professor, Universite de Moncton
ClinicalTrials.gov Identifier: NCT03354351     History of Changes
Other Study ID Numbers: MindTheHeart-UMoncton-2017
First Posted: November 27, 2017    Key Record Dates
Last Update Posted: November 28, 2017
Last Verified: November 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Jalila Jbilou, Universite de Moncton:
Stepped-care model
Men's health
Prevention
Early treatment
Psychotherapy

Additional relevant MeSH terms:
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Disease
Heart Diseases
Depressive Disorder
Anxiety Disorders
Stress Disorders, Post-Traumatic
Cardiovascular Diseases
Mood Disorders
Mental Disorders
Vascular Diseases
Stress Disorders, Traumatic
Trauma and Stressor Related Disorders
Depression
Acute Coronary Syndrome
Pathologic Processes
Behavioral Symptoms
Myocardial Ischemia