Skip to main content
OpenTrials
Active, Not Recruiting

NCT Number: NCT05580718

Online Cognitive Behavioral Therapy Targeting Cardiac Anxiety

The purpose of the present study is to evaluate an internet-delivered exposure-based cognitive behavioral therapy (CBT) protocol tailored for patients following myocardial infaction (MI) to increase Quality of Life (Qol) and physical activity by reducing cardiac anxiety.

Active, Not Recruiting

This study is active but is not currently recruiting participants.

Key information

Conditions

Online CBT Targeting Cardiac Anxiety Cardiovascular Diseases Heart Diseases Infarction Ischemia Myocardial Infarction Myocardial Ischemia Necrosis Pathologic Processes Pathological Conditions, Signs and Symptoms Vascular Diseases

Age range

18 year–80 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Karolinska University Hospital

Stockholm, 11635, Sweden

About this study

In the present research project, the investigators have tailored a CBT protocol to target the hypothesized mechanisms of how cardiac anxiety affects the clinical course of MI; by using exposure therapy to reduce fear, hypervigilance, and misinterpretations of cardiac symptoms to reduce MI-related avoidance and increasing physical activity.

Participants (estimated N=100) are randomized to internet-delivered CBT for 8 weeks or to a waitlist offered treatment as usual. Patients in the control arm will be crossed over to CBT treatment 3 months after the experimental group has completed treatment. Assessments will be conducted pre-treatment, post-treatment, 3 months (primary endpoint), 1-, 2 - and 5 years after treatment. These measurement points will also include the control group as it is crossed over to CBT after the 3-month follow-up

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • Inclusion criteria:
  • Myocardial infarction ≥ 6 months before assessment (type 1 STEMI/NSTEMI)
  • Age 18-80 years;
  • Clinically significant cardiac anxiety that leads to severe distress and/or interferes with daily life
  • On adequate medical treatment(21); (E) 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 percutaneous interventions
  • Any medical restriction to physical exercise
  • Severe medical illness
  • Grade 3 hypertension (i.e., blood pressure ≥ 180 systolic and/or 110 diastolic)
  • Severe psychiatric disorder or risk of suicide
  • Alcohol dependency
  • Ongoing psychological treatment.

Treatment and study plan

MI-CBT

Behavioral
  • Education Common reactions following MI and general lifestyle advice on e.g., physical activity. The role of cardiac anxiety and avoidance behavior on quality of life and physical health. Brief training in self-observation.
  • Goal setting Identifying life areas impaired by MI-related disability or symptom fear. Set health behavioral goals i.e., increased physical activity and gradually take steps towards them.
  • Exposure therapy Exposure to physical sensations (e.g., palpitations due to physical activity) to reduce fear of these symptoms. Gradual exposure to avoided situations, activities and increase in physical activity.
  • Relapse prevention Prevention of relapse into avoidance behaviors by identifying risk situations and conduct a plan forward on maintaining a healthy physically and active lifestyle.

Primary outcomes

  1. Seattle Angina Questionnaire

    Time frame: From baseline to 5 months

    A measure of coronary artery disease on five scales: physical limitation scale, anginal stability scale, anginal frequency scale, treatment satisfaction scale, and the disease. perception scale with a score ranging from 0 to 100. A higher score indicating a better quality of life.

Secondary outcomes

  1. Seattle Angina Questionnaire

    Time frame: From baseline to 8 weeks

    A measure of coronary artery disease on five scales: physical limitation scale, anginal stability scale, anginal frequency scale, treatment satisfaction scale, and the disease perception scale. With a score ranging from 0 to 100. A higher score indicating a better quality of life.

  2. Seattle Angina Questionnaire

    Time frame: Change over 8 measurement points measured from baseline and weekly for 8 weeks during treatment

    A measure of coronary artery disease on five scales: physical limitation scale, anginal stability scale, anginal frequency scale, treatment satisfaction scale, and the disease perception scale. With a score ranging from 0 to 100. A higher score indicating a better quality of life.

  3. Seattle Angina Questionnaire

    Time frame: From baseline to 1 year and 2 months

    A measure of coronary artery disease on five scales: physical limitation scale, anginal stability scale, anginal frequency scale, treatment satisfaction scale, and the disease perception scale. With a score ranging from 0 to 100. A higher score indicating a better quality of life.

  4. Seattle Angina Questionnaire

    Time frame: From baseline to 2 years and 2 months

    A measure of coronary artery disease on five scales: physical limitation scale, anginal stability scale, anginal frequency scale, treatment satisfaction scale, and the disease perception scale. With a score ranging from 0 to 100. A higher score indicating a better quality of life

  5. Seattle Angina Questionnaire

    Time frame: From baseline to 5 years and 2 months

    A measure of coronary artery disease on five scales: physical limitation scale, anginal stability scale, anginal frequency scale, treatment satisfaction scale, and the disease perception scale. With a score ranging from 0 to 100. A higher score indicating a better quality of life.

  6. 12-Item Short-Form Health Survey

    Time frame: From baseline to 8 weeks

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

  7. 12-Item Short-Form Health Survey

    Time frame: From baseline to 5 months

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

  8. 12-Item Short-Form Health Survey

    Time frame: From baseline to 1 year and 2 months

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

  9. 12-Item Short-Form Health Survey

    Time frame: From baseline to 2 year and 2 months

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

  10. 12-Item Short-Form Health Survey

    Time frame: From baseline to 5 year and 2 months

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

  11. Cardiac anxiety questionnaire

    Time frame: From baseline to 8 weeks

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

  12. Cardiac anxiety questionnaire

    Time frame: Change over 8 measurement points measured from baseline and weekly for 8 weeks during treatment

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

  13. Cardiac anxiety questionnaire

    Time frame: From baseline to 5 months

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

  14. Cardiac anxiety questionnaire

    Time frame: From baseline to 1 year and 2 months

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

  15. Cardiac anxiety questionnaire

    Time frame: From baseline to 2 year and 2 months

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

  16. Cardiac anxiety questionnaire

    Time frame: From baseline to 5 year and 2 months

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

  17. Myocardial infarction behavior questionnaire

    Time frame: From baseline to 8 weeks

    MI-related avoidance questionnaire behaviors developed by the research group

  18. Myocardial infarction behavior questionnaire

    Time frame: From baseline to 5 months

    MI-related avoidance questionnaire behaviors developed by the research group

  19. Myocardial infarction behavior questionnaire

    Time frame: From baseline to 1 year and 2 months

    MI-related avoidance questionnaire behaviors developed by the research group. score ranging from 0 to 68 . Higher scores indicate more avoidance behavior.

  20. Myocardial infarction behavior questionnaire

    Time frame: From baseline to 2 years and 2 months

    MI-related avoidance questionnaire behaviors developed by the research group. score ranging from 0 to 68 . Higher scores indicate more avoidance behavior.

  21. Myocardial infarction behavior questionnaire

    Time frame: From baseline to 5 years and 2 months

    MI-related avoidance questionnaire behaviors developed by the research group. score ranging from 0 to 68 . Higher scores indicate more avoidance behavior.

  22. Body Sensation Questionnaire

    Time frame: From baseline to 8 weeks

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

  23. Body Sensation Questionnaire

    Time frame: From baseline to 5 months

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

  24. Body Sensation Questionnaire

    Time frame: From baseline to 1 year and 2 months

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

  25. Body Sensation Questionnaire

    Time frame: From baseline to 2 years and 2 months

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

  26. Body Sensation Questionnaire

    Time frame: From baseline to 5 years and 2 months

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

  27. Symptom checklist Severity and Frequency Scale (SCL, adapted to coronary artery disease)

    Time frame: From baseline to 8 weeks

    Cardiac-related symptoms in two sub scales A) frequency: score ranging from 0-48, with higher score indicating higher frequency of symptoms, B) severity of experienced symptom: score ranging from 0- 48, with a higher score indicating more severe symptoms

  28. Symptom checklist Severity and Frequency Scale (SCL, adapted to coronary artery disease)

    Time frame: From baseline to 5 months

    Cardiac-related symptoms in two sub scales A) frequency: score ranging from 0-48, with higher score indicating higher frequency of symptoms, B) severity of experienced symptom: score ranging from 0- 48, with a higher score indicating more severe symptoms

  29. Symptom checklist Severity and Frequency Scale (SCL, adapted to coronary artery disease)

    Time frame: From baseline to 1 year and 2 months

    Cardiac-related symptoms in two sub scales A) frequency: score ranging from 0-48, with higher score indicating higher frequency of symptoms, B) severity of experienced symptom: score ranging from 0- 48, with a higher score indicating more severe symptoms

  30. Symptom checklist Severity and Frequency Scale (SCL, adapted to coronary artery disease)

    Time frame: From baseline to 2 years and 2 months

    Cardiac-related symptoms in two sub scales A) frequency: score ranging from 0-48, with higher score indicating higher frequency of symptoms, B) severity of experienced symptom: score ranging from 0- 48, with a higher score indicating more severe symptoms

  31. Symptom checklist Severity and Frequency Scale (SCL, adapted to coronary artery disease)

    Time frame: From baseline to 5 years and 2 months

    Cardiac-related symptoms in two sub scales A) frequency: score ranging from 0-48, with higher score indicating higher frequency of symptoms, B) severity of experienced symptom: score ranging from 0- 48, with a higher score indicating more severe symptoms

  32. Patient Health Questionnaire-9

    Time frame: From Baseline to 8 weeks

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

  33. Patient Health Questionnaire-9

    Time frame: From Baseline to 5 months

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

  34. Patient Health Questionnaire-9

    Time frame: From Baseline to 1 year and 2 months

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

  35. Patient Health Questionnaire-9

    Time frame: From Baseline to 2 years and 2 months

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

  36. Patient Health Questionnaire-9

    Time frame: From Baseline to 5 years and 2 months

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

  37. Generalized Anxiety Disorder 7-item

    Time frame: From Baseline to 8 weeks

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

  38. Generalized Anxiety Disorder 7-item

    Time frame: From Baseline to 5 months

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

  39. Generalized Anxiety Disorder 7-item

    Time frame: From Baseline to 1 year and 2 months

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

  40. Generalized Anxiety Disorder 7-item

    Time frame: From Baseline to 2 years and 2 months

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

  41. Generalized Anxiety Disorder 7-item

    Time frame: From Baseline to 5 years and 2 months

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

  42. Perceived stress scale 4-item

    Time frame: Baseline to 8 weeks

    Stress reactivity. A greater score indicate more perceived stress.

  43. Perceived stress scale 4-item

    Time frame: Baseline to 5 months

    Stress reactivity. Score ranges 0-16 and a greater score indicate more perceived stress.

  44. Perceived stress scale 4-item

    Time frame: Baseline to 1 year and 2 months

    Stress reactivity. Score ranges 0-16 and a greater score indicate more perceived stress.

  45. Perceived stress scale 4-item

    Time frame: Baseline to 2 years and 2 months

    Stress reactivity. Score ranges 0-16 and a greater score indicate more perceived stress.

  46. Perceived stress scale 4-item

    Time frame: Baseline to 5 years and 2 months

    Stress reactivity. Score ranges 0-16 and a greater score indicate more perceived stress.

  47. The Godin Leisure-time Exercise and International Physical Activity Questionnaire 1 item on inactivity

    Time frame: Baseline to 8 weeks

    Level of physical activity and inactivity: On the Godin leisure-time excercise: 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. And from International Physical Activity Questionnaire we will use 1 item on inactivity

  48. The Godin Leisure-time Exercise and International Physical Activity Questionnaire 1 item on inactivity

    Time frame: Baseline to 5 months

    Level of physical activity and inactivity: On the Godin leisure-time excercise: 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. And from International Physical Activity Questionnaire we will use 1 item on inactivity

  49. The Godin Leisure-time Exercise and International Physical Activity Questionnaire 1 item on inactivity

    Time frame: Baseline to 1 year and 2 months

    Level of physical activity and inactivity: On the Godin leisure-time excercise: 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. And from International Physical Activity Questionnaire we will use 1 item on inactivity

  50. The Godin Leisure-time Exercise and International Physical Activity Questionnaire 1 item on inactivity

    Time frame: Baseline to 2 years and 2 months

    Level of physical activity and inactivity: On the Godin leisure-time excercise: 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. And from International Physical Activity Questionnaire we will use 1 item on inactivity

  51. The Godin Leisure-time Exercise and International Physical Activity Questionnaire 1 item on inactivity

    Time frame: Baseline to 5 years and 2 months

    Level of physical activity and inactivity: On the Godin leisure-time excercise: 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. And from International Physical Activity Questionnaire we will use 1 item on inactivity

  52. Lifestyle factors: The national Board of health and Welfare questionnaire

    Time frame: Baseline to 8 weeks

    Questionnaire regarding diet (5 item), tobacco (2 item) and alcohol (3 item) diet (5 item), tobacco (2 item) and alcohol (3 item) and BMI.

  53. Lifestyle factors: The national Board of health and Welfare questionnaire

    Time frame: Baseline to 5 months

    Questionnaire regarding diet (5 item), tobacco (2 item) and alcohol (3 item) diet (5 item), tobacco (2 item) and alcohol (3 item) and BMI.

  54. Lifestyle factors: The national Board of health and Welfare questionnaire

    Time frame: Baseline to 1 year and 2 months

    Questionnaire regarding diet (5 item), tobacco (2 item) and alcohol (3 item) diet (5 item), tobacco (2 item) and alcohol (3 item) and BMI.

  55. Lifestyle factors: The national Board of health and Welfare questionnaire

    Time frame: Baseline to 2 years and 2 months

    Questionnaire regarding diet (5 item), tobacco (2 item) and alcohol (3 item) diet (5 item), tobacco (2 item) and alcohol (3 item) and BMI.

  56. Lifestyle factors: The national Board of health and Welfare questionnaire

    Time frame: Baseline to 5 years and 2 months

    Questionnaire regarding diet (5 item), tobacco (2 item) and alcohol (3 item) diet (5 item), tobacco (2 item) and alcohol (3 item) and BMI.

  57. Healthcare consumption and work loss:Tic-P

    Time frame: From baseline to 8 weeks

    The Trimbos and Institute of Medical Technology Assessment Cost Questionnaire for Psychiatry assesses societal cost during the last month. These costs include the participant's health care consumption (direct medical costs), time spent in other health promoting activities (direct non-medical costs), and sick leave, unemployment, and reduced work capacity at work and in the domestic realm (indirect non-medical costs).

  58. Healthcare consumption and work loss:Tic-P

    Time frame: From baseline to 5 months

    The Trimbos and Institute of Medical Technology Assessment Cost Questionnaire for Psychiatry assesses societal cost during the last month. These costs include the participant's health care consumption (direct medical costs), time spent in other health promoting activities (direct non-medical costs), and sick leave, unemployment, and reduced work capacity at work and in the domestic realm (indirect non-medical costs).

  59. Healthcare consumption and work loss:Tic-P

    Time frame: From baseline to 1 year and 2 months

    The Trimbos and Institute of Medical Technology Assessment Cost Questionnaire for Psychiatry assesses societal cost during the last month. These costs include the participant's health care consumption (direct medical costs), time spent in other health promoting activities (direct non-medical costs), and sick leave, unemployment, and reduced work capacity at work and in the domestic realm (indirect non-medical costs).

  60. Healthcare consumption and work loss:Tic-P

    Time frame: From baseline to 2 years and 2 months

    The Trimbos and Institute of Medical Technology Assessment Cost Questionnaire for Psychiatry assesses societal cost during the last month. These costs include the participant's health care consumption (direct medical costs), time spent in other health promoting activities (direct non-medical costs), and sick leave, unemployment, and reduced work capacity at work and in the domestic realm (indirect non-medical costs).

  61. Healthcare consumption and work loss:Tic-P

    Time frame: From baseline to 5 years and 2 months

    The Trimbos and Institute of Medical Technology Assessment Cost Questionnaire for Psychiatry assesses societal cost during the last month. These costs include the participant's health care consumption (direct medical costs), time spent in other health promoting activities (direct non-medical costs), and sick leave, unemployment, and reduced work capacity at work and in the domestic realm (indirect non-medical costs).

  62. University of Toronto Atrial fibrillation Severity Scale (AFSS)

    Time frame: From Baseline to 8 weeks

    3 item on cardiac-specific healthcare consumption. Scores ranges 0-15 with a higher score indicating more cardiac-related healthcare consumption.

  63. University of Toronto Atrial fibrillation Severity Scale (AFSS)

    Time frame: From Baseline to 5 months

    3 item on cardiac-specific healthcare consumption. Scores ranges 0-15 with a higher score indicating more cardiac-related healthcare consumption.

  64. University of Toronto Atrial fibrillation Severity Scale (AFSS)

    Time frame: From Baseline to 1 year and 2 months

    3 item on cardiac-specific healthcare consumption. Scores ranges 0-15 with a higher score indicating more cardiac-related healthcare consumption.

  65. University of Toronto Atrial fibrillation Severity Scale (AFSS)

    Time frame: From Baseline to 2 years and 2 months

    3 item on cardiac-specific healthcare consumption. Scores ranges 0-15 with a higher score indicating more cardiac-related healthcare consumption.

  66. University of Toronto Atrial fibrillation Severity Scale (AFSS)

    Time frame: From Baseline to 5 years and 2 months

    3 item on cardiac-specific healthcare consumption. Scores ranges 0-15 with a higher score indicating more cardiac-related healthcare consumption.

Other outcomes

  1. Number of Participants With Abnormal Laboratory Values

    Time frame: From Baseline to 8 weeks

    Venous blood will be collected for local analyses of fasting plasma glucose, HbA1c, plasma total cholesterol, LDL, HDL, triglycerides, hsCRP, creatinine, stress-related hormones such as cortisol, copeptin and vasopressin

  2. Number of Participants With Abnormal Laboratory Values

    Time frame: From Baseline to 5 months

    Venous blood will be collected for local analyses of fasting plasma glucose, HbA1c, plasma total cholesterol, LDL, HDL, triglycerides, hsCRP, creatinine, stress-related hormones such as cortisol, copeptin and vasopressin

  3. Algometry (Somedic AB, Hörby, Sweden)

    Time frame: From Baseline to 8 weeks

    A pain sensitivity measurement with algometry (Somedic AB, Hörby, Sweden); consisting of a handle with a 1 cm rubber plate at the end will be used. Algometers are used to measure pressure pain thresholds, the exact pressure (kPa) is registered in the algometer and thus a measure of a person's pain threshold can be assessed.

  4. Algometry (Somedic AB, Hörby, Sweden)

    Time frame: From Baseline to 5 months

    A pain sensitivity measurement with algometry (Somedic AB, Hörby, Sweden); consisting of a handle with a 1 cm rubber plate at the end will be used. Algometers are used to measure pressure pain thresholds, the exact pressure (kPa) is registered in the algometer and thus a measure of a person's pain threshold can be assessed.

  5. Accelerometer (Actigraf®)

    Time frame: Baseline to 8 weeks

    An Accelerometer (Actigraf®) will be carried on the wrist over to measure physical activity over 1 week

  6. Accelerometer (Actigraf®)

    Time frame: Baseline to 5 months

    An Accelerometer (Actigraf®) will be carried on the wrist over to measure physical activity over 1 week week at each assessment

  7. Adverse events

    Time frame: From Baseline to 8 weeks

    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. Adverse events

    Time frame: 8 measurement points measured from baseline and weekly for 8 weeks during treatment

    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').

  9. Adverse events

    Time frame: From Baseline to 5 months

    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').

  10. Adverse events

    Time frame: From Baseline to 1 year and 2 months

    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').

  11. Adverse events

    Time frame: From Baseline to 2 years and 2 months

    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').

  12. Adverse events

    Time frame: From Baseline to 5 years and 2 months

    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').

  13. Client satisfaction Questionnaire

    Time frame: Baseline to 8 weeks

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

  14. Treatment Credibility Scale

    Time frame: 1-2 weeks from baseline

    Measures treatment credibility

  15. Working Alliance Inventory

    Time frame: 1-2 weeks from baseline

    Measures therapeutic alliance with the psychologist

  16. Follow-up questions on health changes

    Time frame: Baseline to 8 weeks

    We will ask participant to describe if they have experienced any psychosocial stressors, changes in physical health, such as invasive therapy and changes of medication

  17. Follow-up questions on health changes

    Time frame: Baseline to 5 months

    We will ask participant to describe if they have experienced any psychosocial stressors, changes in physical health, such as invasive therapy and changes of medication

  18. Follow-up questions on health changes

    Time frame: Baseline to 1 year and 2 months

    We will ask participant to describe if they have experienced any psychosocial stressors, changes in physical health, such as invasive therapy and changes of medication

  19. Follow-up questions on health changes

    Time frame: Baseline to 2 years and 2 months

    We will ask participant to describe if they have experienced any psychosocial stressors, changes in physical health, such as invasive therapy and changes of medication

  20. Follow-up questions on health changes

    Time frame: Baseline to 5 years and 2 months

    We will ask participant to describe if they have experienced any psychosocial stressors, changes in physical health, such as invasive therapy and changes of medication

  21. AFFS/SCL-4

    Time frame: Change over 8 measurement points measured from baseline and weekly for 8 weeks during treatment

    4 items derived from the Symptoms Checklist (SCL) and the Atrial Fibrillation Severity Scale (AFSS) measuring disabling cardiac symptoms

  22. MI-behavior Questionnaire

    Time frame: Change over 8 measurement points measured from baseline and weekly for 8 weeks during treatment

    5 items measuring avoidance behavior from the MI-related avoidance questionnaire behaviors developed by the research group

  23. Perceived stress scale 4-item

    Time frame: Change over 8 measurement points measured from baseline and weekly for 8 weeks during treatment

    Measure of perceived stress and stress reactivity. Score ranging 0 -16 with a higher score indicating more perceived stress.

Sponsors and collaborators

Lead sponsor

Karolinska Institutet

Other

Collaborators

  • Sahlgrenska University Hospital
  • Swedish Heart Lung Foundation
  • The Swedish Research Council

Registry information

Official study title

Online Cognitive Behavioral Therapy Targeting Cardiac Anxiety Following Myocardial Infarction: A Randomized Controlled Trial

Acronym: MI-CBT

Important dates

Study start
2022
Primary completion
2025
Study completion
2025
First posted
Oct 14, 2022
Registry last updated
Aug 27, 2024

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.

Related clinical trials

Published trials that share one or more normalized conditions with this study.