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
The study will include 30 patients. The MI-specific CBT lasts for 8 weeks and is therapist guided and delivered via internet via a secure digital platform by licensed psychologists expertise in CBT for cardiac disease or final year psychologist under supervision. 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
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
23
Education of MI and common reactions, Interoceptive exposure, Exposure in-vivo, Behavioral activation, Relapse prevention
Karolinska Institutet
Stockholm, Sweden
12-Item Short-Form Health Survey (SF-12)
General quality of life, with a score ranging from 0 to 100. A higher score indicating a better quality of life. General quality of life, with a score ranging from 0 to 100. A higher score indicating a better quality of life. General quality of life, with a score ranging from 0 to 100. A higher score indicating a better quality of life.
Time frame: Baseline
12-Item Short-Form Health Survey (SF-12)
General quality of life, with a score ranging from 0 to 100. A higher score indicating a better quality of life. General quality of life, with a score ranging from 0 to 100. A higher score indicating a better quality of life. General quality of life, with a score ranging from 0 to 100. A higher score indicating a better quality of life.
Time frame: 2 months from baseline
12-Item Short-Form Health Survey (SF-12)
General quality of life, with a score ranging from 0 to 100. A higher score indicating a better quality of life. General quality of life, with a score ranging from 0 to 100. A higher score indicating a better quality of life. General quality of life, with a score ranging from 0 to 100. A higher score indicating a better quality of life.
Time frame: 8 months from baseline
Cardiac anxiety questionnaire
Measure of cardiac anxiety, fear, avoidance and attention. The score ranges between 0 and 72, with a greater score indicating elevated cardiac anxiety.
Time frame: Baseline
Cardiac anxiety questionnaire
Measure of cardiac anxiety, fear, avoidance and attention. The score ranges between 0 and 72, with a greater score indicating elevated cardiac anxiety.
Time frame: 2 months from baseline
Cardiac anxiety questionnaire
Measure of cardiac anxiety, fear, avoidance and attention. The score ranges between 0 and 72, with a greater score indicating elevated cardiac anxiety.
Time frame: 8 months from baseline
Body Sensation Questionnaire
Fear of bodily symptoms, score ranging from 0 to 72 . Higher scores indicate more fear of body sensations. Fear of bodily symptoms, score ranging from 0 to 72 . Higher scores indicate more fear of body sensations. Fear of bodily symptoms, score ranging from 0 to 72 . Higher scores indicate more fear of body sensations.
Time frame: Baseline
Body Sensation Questionnaire
Fear of bodily symptoms, score ranging from 0 to 72 . Higher scores indicate more fear of body sensations. Fear of bodily symptoms, score ranging from 0 to 72 . Higher scores indicate more fear of body sensations. Fear of bodily symptoms, score ranging from 0 to 72 . Higher scores indicate more fear of body sensations.
Time frame: 2 months from baseline
Body Sensation Questionnaire
Fear of bodily symptoms, score ranging from 0 to 72 . Higher scores indicate more fear of body sensations. Fear of bodily symptoms, score ranging from 0 to 72 . Higher scores indicate more fear of body sensations. Fear of bodily symptoms, score ranging from 0 to 72 . Higher scores indicate more fear of body sensations.
Time frame: 8 months from baseline
Patient Health Questionnaire-9
Measure of depression, score ranging 0 to 27 with a higher score indicating higher level of depression
Time frame: Baseline
Patient Health Questionnaire-9
Measure of depression, score ranging 0 to 27 with a higher score indicating higher level of depression
Time frame: 2 months from baseline
Patient Health Questionnaire-9
Measure of depression, score ranging 0 to 27 with a higher score indicating higher level of depression
Time frame: 8 months from baseline
Generalized Anxiety Disorder 7-item
General anxiety, score ranging from 0-21, with a higher score indicating more anxiety and worry.
Time frame: Baseline
Generalized Anxiety Disorder 7-item
General anxiety, score ranging from 0-21, with a higher score indicating more anxiety and worry.
Time frame: 2 months from baseline
Generalized Anxiety Disorder 7-item
General anxiety, score ranging from 0-21, with a higher score indicating more anxiety and worry.
Time frame: 8 months from baseline
The Godin Leisure-time Exercise
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.
Time frame: Baseline
The Godin Leisure-time Exercise
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.
Time frame: 2 months from baseline
The Godin Leisure-time Exercise
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.
Time frame: 8 months from baseline
Tampas Scale for Kinesophobia-Heart version
Fear of physical activity. The total score varies between 17 and 68, with higher values indicating more severe kinesiophobia.
Time frame: Baseline
Tampas Scale for Kinesophobia-Heart version
Fear of physical activity. The total score varies between 17 and 68, with higher values indicating more severe kinesiophobia.
Time frame: 2 months from baseline
Tampas Scale for Kinesophobia-Heart version
Fear of physical activity. The total score varies between 17 and 68, with higher values indicating more severe kinesiophobia.
Time frame: 8 months from baseline
Client satisfaction Questionnaire
Treatment satisfaction, score ranging from 0 to 32, with a higher score indication more satisfaction with the treatment.
Time frame: Baseline
Client satisfaction Questionnaire
Treatment satisfaction, score ranging from 0 to 32, with a higher score indication more satisfaction with the treatment.
Time frame: 2 months from baseline
Adverse events
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').
Time frame: 2 months from treatment
Adverse events
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').
Time frame: 8 months from treatment
Symptom Checklist (SCL)
Measures frequency and severity of 16 cardiac-related symptoms. Scoring range from 0 to 64 for frequency with a greater score indicating more frequent symptoms, and from range from 0 to 48 for severity, with a greater score indicating more severe symptoms
Time frame: Baseline
Symptom Checklist (SCL)
Measures frequency and severity of 16 cardiac-related symptoms. Scoring range from 0 to 64 for frequency with a greater score indicating more frequent symptoms, and from range from 0 to 48 for severity, with a greater score indicating more severe symptoms
Time frame: 2 months from baseline
Symptom Checklist (SCL)
Measures frequency and severity of 16 cardiac-related symptoms. Scoring range from 0 to 64 for frequency with a greater score indicating more frequent symptoms, and from range from 0 to 48 for severity, with a greater score indicating more severe symptoms
Time frame: 8 months from baseline
Perceived stress scale (4-item version)
Stress reactivity. A greater score indicate more perceived stress.
Time frame: Baseline
Perceived stress scale (4-item version)
Stress reactivity. A greater score indicate more perceived stress.
Time frame: 2 months from Baseline
Perceived stress scale (4-item version)
Stress reactivity. A greater score indicate more perceived stress.
Time frame: 8 months from Baseline
Insomnia Severity Index
Measurement of sleep
Time frame: Baseline
Insomnia Severity Index
Measure of insomnia, score ranging from 0-20, with a higher score indicating more severe insomnia
Time frame: 2 months from Baseline
Insomnia Severity Index
Measure of insomnia, score ranging from 0-20, with a higher score indicating more severe insomnia
Time frame: 8 months from Baseline
The Posttraumatic Stress Disorder Checklist for DSM-5 (PCL-5)
Measure of post traumatic stress, score ranging from 0-80, with a higher score indicating more post traumatic stress.
Time frame: Baseline
The Posttraumatic Stress Disorder Checklist for DSM-5 (PCL-5)
Measure of post traumatic stress, score ranging from 0-80, with a higher score indicating more post traumatic stress.
Time frame: 2 months from Baseline
The Posttraumatic Stress Disorder Checklist for DSM-5 (PCL-5)
Measure of post traumatic stress, score ranging from 0-80, with a higher score indicating more post traumatic stress.
Time frame: 8 months from Baseline
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.