MI-CBT: Online Cognitive Behavioral Therapy Targeting Cardiac Anxiety

Sponsor
Karolinska Institutet (Other)
Overall Status
Recruiting
CT.gov ID
NCT05580718
Collaborator
Swedish Heart Lung Foundation (Other), The Swedish Research Council (Other), Sahlgrenska University Hospital, Sweden (Other)
100
1
2
20.9
4.8

Study Details

Study Description

Brief Summary

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.

Condition or Disease Intervention/Treatment Phase
  • Behavioral: MI-CBT
N/A

Detailed Description

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

Study Design

Study Type:
Interventional
Anticipated Enrollment :
100 participants
Allocation:
Randomized
Intervention Model:
Crossover Assignment
Masking:
None (Open Label)
Primary Purpose:
Treatment
Official Title:
Online Cognitive Behavioral Therapy Targeting Cardiac Anxiety Following Myocardial Infarction: A Randomized Controlled Trial
Actual Study Start Date :
Oct 17, 2022
Anticipated Primary Completion Date :
Jul 14, 2024
Anticipated Study Completion Date :
Jul 14, 2024

Arms and Interventions

Arm Intervention/Treatment
Experimental: Online CBT targeting cardiac anxiety

CBT for MI primarily targets two processes of MI-related disability: fear of cardiac-related symptoms avoidance behavior and physical inactivity. The CBT is therapist-guided and lasts for 8 weeks.

Behavioral: MI-CBT
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.

No Intervention: Waitlist control

Participants randomised to waitlist can have no other concurrent psychological treatment but are free to use any medical treatment as usual. Participants on the waitlist also complete pre- and post-treatment, the follow-up measurement as well as weekly instruments (with exception of the treatment process measures Credibility scale and WAI). After the 3-month follow-up assessments, participants will receive internet-CBT for MI over 8 weeks

Outcome Measures

Primary Outcome Measures

  1. Seattle Angina Questionnaire [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 Outcome Measures

  1. Seattle Angina Questionnaire [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 [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 [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 [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 [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 [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 [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 [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 [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 [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 [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 [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 [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 [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 [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 [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 [From baseline to 8 weeks]

    MI-related avoidance questionnaire behaviors developed by the research group

  18. Myocardial infarction behavior questionnaire [From baseline to 5 months]

    MI-related avoidance questionnaire behaviors developed by the research group

  19. Myocardial infarction behavior questionnaire [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 [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 [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 [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 [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 [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 [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 [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) [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) [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) [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) [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) [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 [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 [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 [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 [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 [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 [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 [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 [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 [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 [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 [Baseline to 8 weeks]

    Stress reactivity. A greater score indicate more perceived stress.

  43. Perceived stress scale 4-item [Baseline to 5 months]

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

  44. Perceived stress scale 4-item [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 [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 [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 [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 [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 [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 [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 [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 [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 [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 [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 [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 [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 [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 [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 [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 [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 [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) [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) [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) [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) [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) [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 Outcome Measures

  1. Number of Participants With Abnormal Laboratory Values [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 [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) [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) [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®) [Baseline to 8 weeks]

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

  6. Accelerometer (Actigraf®) [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 [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 [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 [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 [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 [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 [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 [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 [1-2 weeks from baseline]

    Measures treatment credibility

  15. Working Alliance Inventory [1-2 weeks from baseline]

    Measures therapeutic alliance with the psychologist

  16. Follow-up questions on health changes [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 [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 [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 [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 [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 [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 [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 [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.

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years to 80 Years
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
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.

Contacts and Locations

Locations

Site City State Country Postal Code
1 Karolinska University Hospital Stockholm Sweden 11635

Sponsors and Collaborators

  • Karolinska Institutet
  • Swedish Heart Lung Foundation
  • The Swedish Research Council
  • Sahlgrenska University Hospital, Sweden

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Josefin Särnholm, Principal Investigator, PhD, Karolinska Institutet
ClinicalTrials.gov Identifier:
NCT05580718
Other Study ID Numbers:
  • MI-RCT1
First Posted:
Oct 14, 2022
Last Update Posted:
Jan 11, 2023
Last Verified:
Jan 1, 2023
Individual Participant Data (IPD) Sharing Statement:
No
Plan to Share IPD:
No
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Keywords provided by Josefin Särnholm, Principal Investigator, PhD, Karolinska Institutet
Additional relevant MeSH terms:

Study Results

No Results Posted as of Jan 11, 2023