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Completed

NCT Number: NCT04649307

Cognitive Behavioral Therapy Following Myocardial Infarction

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.

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Key information

Conditions

Myocardial Infarction Behavior Cardiovascular Diseases Heart Diseases Infarction Ischemia Motor Activity Myocardial Ischemia Necrosis Pathologic Processes Pathological Conditions, Signs and Symptoms Vascular Diseases

Age range

18 year–75 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Karolinska University Hospital

Stockholm, Sweden

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

MI-CBT

Behavioral

Education, Interoceptive exposure, Exposure in-vivo, Behavioral activation, Relapse prevention

Primary outcomes

  1. Cardiac anxiety questionnaire

    Time frame: baseline

    Measure of cardiac anxiety, fear, avoidance and attention. The score ranges between 0 and 72, with a greater score indicating elevated cardiac anxiety.

  2. Cardiac anxiety questionnaire

    Time frame: 2 months from baseline

    Measure of cardiac anxiety, fear, avoidance and attention. The score ranges between 0 and 72, with a greater score indicating elevated cardiac anxiety.

  3. Cardiac anxiety questionnaire

    Time frame: 8 months from 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 outcomes

  1. 12-Item Short-Form Health Survey (SF-12)

    Time frame: Baseline

    General quality of life, with a score ranging from 0 to 100. A higher score indicating a better quality of life.

  2. 12-Item Short-Form Health Survey (SF-12)

    Time frame: 2 months from baseline

    General quality of life, with a score ranging from 0 to 100. A higher score indicating a better quality of life.

  3. 12-Item Short-Form Health Survey (SF-12)

    Time frame: 8 months from baseline

    General quality of life, with a score ranging from 0 to 100. A higher score indicating a better quality of life.

  4. Body Sensation Questionnaire

    Time frame: Baseline

    Fear of bodily symptoms, score ranging from 0 to 72 . Higher scores indicate more fear of body sensations.

  5. Body Sensation Questionnaire

    Time frame: 2 months from baseline

    Fear of bodily symptoms, score ranging from 0 to 72 . Higher scores indicate more fear of body sensations.

  6. Body Sensation Questionnaire

    Time frame: 8 months from baseline

    Fear of bodily symptoms, score ranging from 0 to 72 . Higher scores indicate more fear of body sensations.

  7. Patient Health Questionnaire-9

    Time frame: Baseline

    Measure of depression, score ranging 0 to 27 with a higher score indicating higher level of depression.

  8. Patient Health Questionnaire-9

    Time frame: 2 months from Baseline

    Measure of depression, score ranging 0 to 27 with a higher score indicating higher level of depression.

  9. Patient Health Questionnaire-9

    Time frame: 8 months from Baseline

    Measure of depression, score ranging 0 to 27 with a higher score indicating higher level of depression.

  10. Generalized Anxiety Disorder 7-item

    Time frame: Baseline

    General anxiety, score ranging from 0-21, with a higher score indicating more anxiety and worry.

  11. Generalized Anxiety Disorder 7-item

    Time frame: 2 months from baseline

    General anxiety, score ranging from 0-21, with a higher score indicating more anxiety and worry.

  12. Generalized Anxiety Disorder 7-item

    Time frame: 8 months from baseline

    General anxiety, score ranging from 0-21, with a higher score indicating more anxiety and worry.

  13. The Godin Leisure-time Exercise

    Time frame: 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.

  14. The Godin Leisure-time Exercise

    Time frame: 2 months from 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.

  15. The Godin Leisure-time Exercise

    Time frame: 8 months from 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.

  16. Tampas Scale for Kinesophobia-Heart version

    Time frame: Baseline

    Fear of physical activity. The total score varies between 17 and 68, with higher values indicating more severe kinesiophobia.

  17. Tampas Scale for Kinesophobia-Heart version

    Time frame: 2 months from Baseline

    Fear of physical activity. The total score varies between 17 and 68, with higher values indicating more severe kinesiophobia.

  18. Tampas Scale for Kinesophobia-Heart version

    Time frame: 8 months form Baseline

    Fear of physical activity. The total score varies between 17 and 68, with higher values indicating more severe kinesiophobia.

  19. Client satisfaction Questionnaire

    Time frame: 2 months from Baseline

    Treatment satisfaction, score ranging from 0 to 32, with a higher score indication more satisfaction with the treatment.

  20. Adverse events

    Time frame: 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').

  21. Adverse events

    Time frame: 8 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').

Sponsors and collaborators

Lead sponsor

Karolinska Institutet

Other

Registry information

Acronym: MI-CBT

Important dates

Study start
2020
Primary completion
2021
Study completion
2021
First posted
Dec 2, 2020
Registry last updated
May 24, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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