Internet-delivered Cognitive Behavioral Therapy Following Myocardial Infarction

Study Overview
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Brief Summary
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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
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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

Official Title
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Internet-delivered Cognitive Behavioral Therapy Following Myocardial Infarction

Conditions
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Exposure, CBT, Myocardial Infarction, Cardiac Anxiety

Intervention / Treatment
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* Behavioral: MI-CBT


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: ( - )MI ≥ 6 months before assessment ( - )Age 18-75 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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 75 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Other: MI-CBT via the Internet<br>The MI-specific CBT will consist of 8 modules delivered via the Internet with home assignments that can be reviewed and reported in the research groups secure platform. | Behavioral: MI-CBT<br>* Education of MI and common reactions, Interoceptive exposure, Exposure in-vivo, Behavioral activation, Relapse prevention<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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. | 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. | 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. | 8 months from baseline | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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. | 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. | 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. | 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. | 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. | 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. | 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 | Baseline | 
| Patient Health Questionnaire-9 | Measure of depression, score ranging 0 to 27 with a higher score indicating higher level of depression | 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 | 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. | Baseline | 
| Generalized Anxiety Disorder 7-item | General anxiety, score ranging from 0-21, with a higher score indicating more anxiety and worry. | 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. | 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. | 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. | 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. | 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. | 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. | 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. | 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. | Baseline | 
| Client satisfaction Questionnaire | Treatment satisfaction, score ranging from 0 to 32, with a higher score indication more satisfaction with the treatment. | 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'). | 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'). | 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 | 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 | 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 | 8 months from baseline | 
| Perceived stress scale (4-item version) | Stress reactivity. A greater score indicate more perceived stress. | Baseline | 
| Perceived stress scale (4-item version) | Stress reactivity. A greater score indicate more perceived stress. | 2 months from Baseline | 
| Perceived stress scale (4-item version) | Stress reactivity. A greater score indicate more perceived stress. | 8 months from Baseline | 
| Insomnia Severity Index | Measurement of sleep | Baseline | 
| Insomnia Severity Index | Measure of insomnia, score ranging from 0-20, with a higher score indicating more severe insomnia | 2 months from Baseline | 
| Insomnia Severity Index | Measure of insomnia, score ranging from 0-20, with a higher score indicating more severe insomnia | 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. | 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. | 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. | 8 months from Baseline |