Comorbid Mental Disease and Heart Disease in Men

NCT03354351 | Unknown DMC

• 1 other identifier: MindTheHeart-UMoncton-2017
• Study Type: observational
• Target: 3,000
• Locations: 0 countries
• Sites: N/A

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.

Conditions

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

Keywords

Stepped-care model; Men's health; Prevention; Early treatment; Psychotherapy

Outcome Measures

Primary Outcomes (3)

• Change from Baseline PHQ9 at 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)

  Baseline, 3 months, 6 months, 9 months and 12 months

• Change from Baseline DASS-21 at 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.

  Baseline, 3 months, 6 months, 9 months and 12 months

• Change from Baseline IES-R at 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.

  Baseline, 3 months, 6 months, 9 months and 12 months

Secondary Outcomes (2)

• 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

Other Outcomes (2)

• Change from Baseline GAD-7 at 12 months

  Baseline, 3 months, 6 months, 9 months and 12 months

• Change from Baseline MDRS-22 at 12 months

  Baseline, 3 months, 6 months, 9 months and 12 months

Study Arms (3)

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

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

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

Interventions

Stepped-care model BEHAVIORAL

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.

Also known as: MindTheHeart

NB-Group; ON-Group; QC-Group

Eligibility Criteria

• Age: 18 Years - 95 Years
• Sex: male
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Universite de Moncton: lead
• Movember Foundation: collaborator
• New Brunswick Health Research Foundation: collaborator

MeSH Terms

Conditions

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

Condition Hierarchy (Ancestors)

Myocardial Ischemia; Heart Diseases; Cardiovascular Diseases; Vascular Diseases; Mood Disorders; Mental Disorders; Stress Disorders, Traumatic; Trauma and Stressor Related Disorders

Study Officials

• Jalila Jbilou, MD, PhD

  Universite de Moncton

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Jalila Jbilou, MD, PhD

CONTACT

506-858-4931; jalila.jbilou@umoncton.ca

Rana Sughayar, MSc

CONTACT

506-858-4721; rana.sughayar@umoncton.ca

Study Design

• Study Type: observational
• Observational Model: ECOLOGIC OR COMMUNITY
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate professor

Study Record Dates

• First Submitted: November 16, 2017
• First Posted: November 27, 2017
• Study Start: December 1, 2017
• Primary Completion: December 31, 2018
• Study Completion: December 31, 2019
• Last Updated: November 28, 2017

Record last verified: 2017-11

Data Sharing

• IPD Sharing: Will not share