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Completed

NCT Number: NCT05607992

Brief Internet-delivered CBT After ACS

The purpose of the present pilot study is to evaluate the feasibility and potential efficacy of a brief, internet-delivered CBT protocol provided early after acute coronary syndrome (ACS).

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Key information

Conditions

Psychological Trauma Acute Coronary Syndrome Cardiovascular Diseases Heart Diseases Mental Disorders Myocardial Ischemia Stress Disorders, Post-Traumatic Stress Disorders, Traumatic Trauma and Stressor Related Disorders Vascular Diseases

Age range

18 year–80 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Karolinska Institutet, Stockholm, Sweden

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About this study

Acute coronary syndrome (ACS; myocardial infarction (MI) or unstable angina (UA)) is one of the leading causes of mortality and health loss globally. ACS is a stressful and potentially life-threatening cardiovascular event, and many patients develop symptoms of post-traumatic stress (PTSS) and cardiac anxiety post ACS, which have been shown to negatively affect patients' long-term cardiovascular prognosis.The aim of the proposed pilot study is to develop and evaluate a brief internet-delivered exposure-based CBT intervention provided early following ACS to reduce ACS-related PTSS, cardiac anxiety. and increase physical activity and quality of life. Patients with recent ACS (≥ 4 weeks to 6 months) and with elevated PTSS and anxiety will be eligible. After informed consent, patients will be randomized to internet-delivered CBT (N=15) or to a wait-list control group (N=15). The treatment is a 5 week, therapist-guided, internet-delivered intervention which includes imaginal exposure, interoceptive exposure, and exposure in-vivo. Assessments will be conducted at baseline, immediate post-treatment, and 2- and 6- months after treatment. The wait-list will be crossed over to CBT after completion of the 2 month follow-up.

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • (A) ACS ≥ four weeks to six months before assessment (MI type 1 STEMI/NSTEMI and UA)
  • (B) Age 18-80 years
  • (C) Symptoms of PTSD and/or cardiac anxiety that leads to distress and/or interferes with daily life (PCL5; ≥ 10, CAQ: ≥20)
  • (D) On standard of care medical treatment for the cardiac condition according to Swedish cardiovascular guidelines
  • (E) Ability to read and write in Swedish.

Exclusion criteria

  • (F) Heart failure with severe systolic dysfunction (ejection fraction ≤ 35%)
  • (G) Significant valvular disease
  • (H) Planned coronary artery bypass surgery or percutaneous interventions
  • (I) Any medical restriction to physical exercise
  • (J) Severe uncontrolled medical illness i.e., advanced cancer
  • (K) Grade 3 hypertension (i.e., blood pressure ≥ 180 systolic and/or 110 diastolic)
  • (L) Severe psychiatric disorder, active suicidal ideations or cognitive impairment that precludes provision of informed consent or study activities
  • (M) Alcohol dependency
  • (N) Ongoing psychological treatment.

Treatment and study plan

Brief exposure-based CBT

Behavioral

The 5-week intervention is psychologist-guided and delivered via text-based interactive online treatment modules, where patients complete weekly homework assignments and have regular online contact with psychologists with training in CBT for cardiac disease. Key components include imaginal exposure of the ACS event, interoceptive exposure through at home physical activity that stimulats the CV system, exposure in-vivo to reduce avoided situations, and activities to enhance physical activity wellbeing. Labeling (i.e., describing cardiac-related symptoms, thoughts, and feelings) will be used continuously during treatment to enhance the effect of exposure.

Primary outcomes

  1. Seattle Angina Questionnaire

    Time frame: Baseline to 3 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.

  2. Acceptability: Client satisfaction Questionnaire

    Time frame: Baseline to 5 weeks

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

  3. Percentage of enrolled participants who complete the treatment

    Time frame: Baseline to 5 weeks

    Feasibility of the intervention components will be assessed by >60% assessed as treatment completers. Descriptive analysis will also provide number of messages and therapist time.

  4. Adverse events

    Time frame: Baseline to 5 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').

Secondary outcomes

  1. Seattle Angina Questionnaire

    Time frame: Baseline to 5 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: Baseline to 7 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.

  3. Seattle Angina Questionnaire

    Time frame: Change over 5 measurement points measured from baseline and weekly for 5 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.

  4. The Posttraumatic Stress Disorder Checklist for DSM-5 (PCL-5

    Time frame: Baseline to 5 weeks

    Measure of post traumatic stress, score ranging from 0-80, with a higher score indicating more post traumatic stress.

  5. The Posttraumatic Stress Disorder Checklist for DSM-5 (PCL-5

    Time frame: Baseline to 3 months

    Measure of post traumatic stress, score ranging from 0-80, with a higher score indicating more post traumatic stress.

  6. The Posttraumatic Stress Disorder Checklist for DSM-5 (PCL-5

    Time frame: Baseline to 7 months

    Measure of post traumatic stress, score ranging from 0-80, with a higher score indicating more post traumatic stress.

  7. The Posttraumatic Stress Disorder Checklist for DSM-5 (PCL-5

    Time frame: Change over 5 measurement points measured from baseline and weekly for 5 weeks during treatment

    Measure of post traumatic stress, score ranging from 0-80, with a higher score indicating more post traumatic stress.

  8. Cardiac anxiety questionnaire

    Time frame: Baseline to 5 weeks

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

  9. Cardiac anxiety questionnaire

    Time frame: Baseline to 3 months

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

  10. Cardiac anxiety questionnaire

    Time frame: Baseline to 7 months

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

  11. Cardiac anxiety questionnaire

    Time frame: Change over 5 measurement points measured from baseline and weekly for 5 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.

  12. Myocardial infarction behavior questionnaire

    Time frame: Baseline to 8 weeks.

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

  13. Myocardial infarction behavior questionnaire

    Time frame: Baseline to 3 months

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

  14. Myocardial infarction behavior questionnaire

    Time frame: Baseline to 7 months

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

  15. Body Sensation Questionnaire

    Time frame: Baseline to 8 weeks

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

  16. Body Sensation Questionnaire

    Time frame: Baseline to 3 months

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

  17. Body Sensation Questionnaire

    Time frame: Baseline to 7 months

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

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

    Time frame: 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

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

    Time frame: Baseline to 3 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

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

    Time frame: Baseline to 7 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

  21. 12-Item Short-Form Health Survey

    Time frame: Baseline to 5 weeks

    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

  22. 12-Item Short-Form Health Survey

    Time frame: Baseline to 3 months

    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

  23. 12-Item Short-Form Health Survey

    Time frame: Baseline to 7 months

    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

  24. Patient Health Questionnaire-9

    Time frame: Baseline to 5 weeks

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

  25. Patient Health Questionnaire-9

    Time frame: Baseline to 3 months

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

  26. Patient Health Questionnaire-9

    Time frame: Baseline to 7 months

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

  27. Generalized Anxiety Disorder 7-item

    Time frame: Baseline to 5 weeks.

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

  28. Generalized Anxiety Disorder 7-item

    Time frame: Baseline to 3 months

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

  29. Generalized Anxiety Disorder 7-item

    Time frame: Baseline to 7 months

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

  30. Perceived stress scale 4-item

    Time frame: Baseline to 5 weeks

    Stress reactivity. A greater score indicate more perceived stress.

  31. Perceived stress scale 4-item

    Time frame: Baseline to 3 months

    Stress reactivity. A greater score indicate more perceived stress.

  32. Perceived stress scale 4-item

    Time frame: Baseline to 7 months

    Stress reactivity. A greater score indicate more perceived stress.

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

    Time frame: Baseline to 5 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

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

    Time frame: Baseline to 3 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

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

    Time frame: Baseline to 7 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

  36. 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)

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

    Time frame: Baseline to 3 months

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

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

    Time frame: Baseline to 7 months

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

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

    Time frame: Baseline to 5 weeks

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

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

    Time frame: Baseline to 3 months

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

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

    Time frame: Baseline to 7 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. Adverse events

    Time frame: Baseline to 3 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').

  2. Adverse events

    Time frame: Baseline to 7 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').

  3. Adverse events

    Time frame: 5 measurement points measured from baseline and weekly for 5 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').

  4. AFFS/SCL-4

    Time frame: Change over 5 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

Sponsors and collaborators

Lead sponsor

Karolinska Institutet

Other

Collaborators

  • Columbia University

Registry information

Official study title

Brief Internet-delivered Exposure-based Therapy to Reduce Post-traumatic Stress Symptoms and Cardiac Anxiety After Acute Coronary Syndrome: a Pilot Randomized Clinical Trial

Important dates

Study start
2023
Primary completion
2024
Study completion
2024
First posted
Nov 7, 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.

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