Myocardial Infarction
Conditions
Keywords
CBT, Cardiac anxiety, Quality of Life, Physical activity
Brief summary
Myocardial infarction (MI) is one of the leading cause s of health loss globally, representing a large proportion of general disability. Anxiety and depression occur in 20-30 percent of patients following MI and have been identified as risk factors for recurrent adverse cardiac event. The purpose of our this study is to develop and evaluate a disease specific cognitive behavioral therapy (C BT) protocol to reduce cardia anxiety, depression, increase physical inactivity and quality of life (Q oL) in patients following MI.
Detailed description
The study will include 20 patients. The MI-specific CBT lasts for 8 weeks and is delivered face-to-face via a secure digital video solution (to minimize cancelled sessions because of the COVID-19 pandemic) or at the Karolinska Universitetssjukhuset cardiac research unit, by licensed psychologists with expertise in CBT for cardiac disease. During treatment, the psychologists will have direct access to a cardiologist assigned to the project and treatments are conducted in close interdisciplinary collaboration to ensure patient safety.
Interventions
BEHAVIORALMI-CBT
Education, Interoceptive exposure, Exposure in-vivo, Behavioral activation, Relapse prevention
Sponsors
Karolinska Institutet
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 75 Years
Healthy volunteers
No
Inclusion criteria
( - )MI ≥ 6 months before assessment (type 1 STEMI/NSTEMI) ( - )Age 18-69 years endorsed cardiac anxiety that leads to significant distress or interferes with daily life (Cardiac Anxiety Questionnaire (CAQ); score ≥20) ( - ) On optimal medical treatment ( - )Able to read and write in Swedish.
Exclusion criteria
( - ) heart failure with severe systolic dysfunction (ejection fraction ≤ 35%) ( - ) significant valvular disease ( - ) planned coronary artery bypass surgery or other invasive therapy ( - ) other severe medical illness ( - )any medical restriction to physical exercise ( - )severe psychiatric disorder, severe depression, or risk of suicide ( - )alcohol dependency.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Cardiac anxiety questionnaire | baseline | Measure of cardiac anxiety, fear, avoidance and attention. The score ranges between 0 and 72, with a greater score indicating elevated cardiac anxiety. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Body Sensation Questionnaire | Baseline | Fear of bodily symptoms, score ranging from 0 to 72 . Higher scores indicate more fear of body sensations. |
| Patient Health Questionnaire-9 | Baseline | Measure of depression, score ranging 0 to 27 with a higher score indicating higher level of depression. |
| Generalized Anxiety Disorder 7-item | Baseline | General anxiety, score ranging from 0-21, with a higher score indicating more anxiety and worry. |
| 12-Item Short-Form Health Survey (SF-12) | Baseline | General quality of life, with a score ranging from 0 to 100. A higher score indicating a better quality of life. |
| Tampas Scale for Kinesophobia-Heart version | Baseline | Fear of physical activity. The total score varies between 17 and 68, with higher values indicating more severe kinesiophobia. |
| Client satisfaction Questionnaire | 2 months from Baseline | Treatment satisfaction, score ranging from 0 to 32, with a higher score indication more satisfaction with the treatment. |
| Adverse events | 2 months from baseline | Potential adverse reactions to the treatment. Participants will be asked to report and rate the short- and long term discomfort of the adverse event on a scale from 0 ('did not affect me at all') and 3 ('affected me very negatively'). |
| The Godin Leisure-time Exercise | Baseline | Level of physical activity. The participant rate numbers of time per week that they engage in physical activity. The numb ers are the categorized in to low, moderate, and high levels of physical activity. |
Countries
Sweden
Outcome results
None listed