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NCT Number: NCT06298864

Internet-based Behavioral Intervention Following ACS

The aim of this study is to evaluate if an online Cognitive Behavioral Therapy (CBT) protocol customized for patients following Acute Coronary Syndrome (ACS), reduce cardiac anxiety, enhance Quality of Life (QoL), and promote increased physical activity while controlling for caregiver attention, utilizing an active control group receiving internet-based cardiac lifestyle intervention.

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Key information

Conditions

Acute Coronary Syndrome Cardiovascular Diseases Heart Diseases Myocardial Ischemia Online CBT Targeting Cardiac Anxiety Vascular Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Karolinska University Hospital

Stockholm, 11635, Sweden

Location status: Recruiting

Location contact

Josefin Särnholm, PhD

CONTACT

About this study

ACS is a leading global cause of mortality and health-related losses. Following ACS, many individuals exhibit symptoms of anxiety and depression, recognized risk factors for recurrent cardiovascular events. Specifically, anxiety related to cardiac symptoms and avoidance behavior, known as cardiac anxiety, has been shown to increase the long-term risk of adverse cardiac events.

The purpose of the present interdisciplinary research project is to develop and evaluate an online CBT protocol tailored for ACS patients. This project comprises a series of clinical studies aimed at accumulating knowledge about the most effective ways to treat ACS patients with CBT over the internet.

The aim of this study is to assess whether internet-based CBT, following ACS, reduces cardiac anxiety and improves QoL, while controlling for caregiver attention and expectancy of improvement using an active control group.

Method: A randomized controlled trial is conducted where participants are randomly assigned to either internet-based CBT (N= 88) or internet-based cardiac lifestyle intervention (internet-CL) (N= 88). The active control group receives internet-CL, focusing on lifestyle modification and health-promoting behaviors. Weekly therapist support through online written communication is provided to participants in both groups. Both treatment are conducted over 8-weeks and are comparable in terms of the number of treatment modules, intensity, and attention from the treating psychologist.

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • ACS ≥ 6 months before assessment (type 1 MI STEMI/NSTEMI or unstable angina [UA])
  • Age 18 and older
  • Clinically significant cardiac anxiety that leads to distress and/or interferes with daily life (Cardiac Anxiety Questionnaire; CAQ: ≥18
  • Able to read and write in Swedish

Exclusion criteria

  • Heart failure New York heart Association class IV or ejection fraction ≤ 30%
  • Significant valvular disease
  • Planned coronary artery bypass surgery or percutaneous interventions
  • Any medical restriction to physical exercise
  • Severe medical illness or an acute health threatening disease (e.g., cancer)
  • Grade 3 hypertension (i.e., blood pressure ≥ 180 systolic and/or 110 diastolic)
  • Severe mental illness requiring urgent psychiatric hospitalization or intervention, or risk of suicide
  • Alcohol or substance use disorder that would impede ability to complete study protocol
  • Ongoing psychological treatment

Treatment and study plan

Internet-CBT

Behavioral
  • Common reactions following ACS. The role of cardiac anxiety and avoidance behavior on quality of life and physical health. Brief training in self-observation, i.e., labeling. General lifestyle advice on e.g., physical activity, diet.
  • Identifying life areas impaired by ACS-related disability or symptom fear. Set health behavioral goals i.e., increased physical activity and gradually take steps towards them.
  • Gradual 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.
  • Prevention of relapse into avoidance behaviors by identifying risk situations and conduct a plan forward on maintaining a healthy physically and active lifestyle.

Internet-CL

Behavioral
  • Education on ACS, risk factors, its treatments and medication.
  • Education and advice promoting healthy habits regarding diet, alcohol and tobacco.
  • Education and advice regarding physical activity and the beneficial effects on health.
  • Education regarding common emotional reactions following ACS.
  • Prevention of relapse and plan forward to maintain a healthy lifestyle.

Primary outcomes

  1. Cardiac anxiety questionnaire modified for weekly assessment

    Time frame: Change over 9 measurement points measured from baseline and weekly for 8 weeks during treatment [PRIMARY ENDPOINT]

    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. Cardiac anxiety questionnaire

    Time frame: From baseline to 8 months

    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: 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.

  3. HeartQoL Health-related Quality of Life Questionnaire modified for weekly assessment

    Time frame: Change over 9 measurement points measured from baseline and weekly for 8 weeks during treatment

    The HeartQoL questionnaire, comprising 14 items, includes a Global scale of 14 items, further divided into Physical (10 items) and Emotional (4 items) subscales. Scores range from 0 to 3, with 3 indicating the highest level and 0 the lowest.

  4. HeartQoL Health-related Quality of Life Questionnaire

    Time frame: From baseline to 8 months

    The HeartQoL questionnaire, comprising 14 items, includes a Global scale of 14 items, further divided into Physical (10 items) and Emotional (4 items) subscales. Scores range from 0 to 3, with 3 indicating the highest level and 0 the lowest.

  5. HeartQoL Health-related Quality of Life Questionnaire

    Time frame: From baseline to 1 year and 2 months

    The HeartQoL questionnaire, comprising 14 items, includes a Global scale of 14 items, further divided into Physical (10 items) and Emotional (4 items) subscales. Scores range from 0 to 3, with 3 indicating the highest level and 0 the lowest.

  6. Symptom checklist Severity and Frequency Scale (SCL, adapted to coronary artery disease) modified for weekly assessment

    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

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

    Time frame: From baseline to 8 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

  8. 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

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

    Time frame: 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

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

    Time frame: From baseline to 8 months

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

  11. 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

  12. Behaviors following cardiac event questionnaire (BCEQ)

    Time frame: From baseline to 8 weeks

    MI-related avoidance questionnaire behaviors developed by the research group

  13. Behaviors following cardiac event questionnaire (BCEQ)

    Time frame: From baseline to 8 months

    MI-related avoidance questionnaire behaviors developed by the research group

  14. Behaviors following cardiac event questionnaire (BCEQ)

    Time frame: From baseline to 1 year and 2 months

    MI-related avoidance questionnaire behaviors developed by the research group

  15. DOSE Non-Adherence questionnaire

    Time frame: From baseline to 8 weeks

    3 items from this two domain scale measuring medical adherence designed to assess missed doses and reasons for missed doses.

  16. DOSE Non-Adherence questionnaire

    Time frame: From baseline to 8 months

    3 items from this two domain scale measuring medical adherence designed to assess missed doses and reasons for missed doses.

  17. DOSE Non-Adherence questionnaire

    Time frame: From baseline to 1 year and 2 months

    3 items from this two domain scale measuring medical adherence designed to assess missed doses and reasons for missed doses.

  18. Perceived stress scale 4-item

    Time frame: Baseline to 8 weeks

    Stress reactivity. A greater score indicate more perceived stress.

  19. Perceived stress scale 4-item

    Time frame: Baseline to 8 months

    Stress reactivity. A greater score indicate more perceived stress.

  20. Perceived stress scale 4-item

    Time frame: Baseline to 1 year and 2 months

    Stress reactivity. A greater score indicate more perceived stress.

  21. Short Fatigue questionnaire

    Time frame: From baseline to 8 weeks

    4-item scale measuring fatigue.

  22. Short Fatigue questionnaire

    Time frame: Baseline to 8 months

    4-item scale measuring fatigue.

  23. Short Fatigue questionnaire

    Time frame: Baseline to 1 year and 2 months

    4-item scale measuring fatigue.

  24. 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

  25. Patient Health Questionnaire-9

    Time frame: From Baseline to 8 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: 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

  27. Insomnia Severity Index

    Time frame: From Baseline to 8 weeks

    Measurement of the degree of sleep difficulties. The total score can range from 0 to 28 points. Higher scores indicate more severe sleep difficulties.

  28. Insomnia Severity Index

    Time frame: From Baseline to 8 months

    Measurement of the degree of sleep difficulties. The total score can range from 0 to 28 points. Higher scores indicate more severe sleep difficulties.

  29. Insomnia Severity Index

    Time frame: From Baseline to 1 year and 2 months

    Measurement of the degree of sleep difficulties. The total score can range from 0 to 28 points. Higher scores indicate more severe sleep difficulties.

  30. Perceived stress scale 4-item

    Time frame: Change over 9 measurement points measured from baseline and weekly for 8 weeks during treatment

    Stress reactivity. A greater score indicate more perceived stress.

  31. 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

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

    Time frame: Baseline to 8 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

  33. 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

  34. 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.

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

    Time frame: Baseline to 8 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.

  36. 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.

  37. Aversive cognition to medication

    Time frame: Baseline to 8 weeks

    : A 3-item subset of questions with regards to psychological distress associated with cardiac medication

  38. Adversive cognition to medication

    Time frame: Baseline to 8 months

    : A 3-item subset of questions with regards to psychological distress associated with cardiac medication

  39. Adversive cognition to medication

    Time frame: Baseline to 1 year and 2 months

    : A 3-item subset of questions with regards to psychological distress associated with cardiac medication

Other outcomes

  1. Adverse events

    Time frame: Baseline to 8 weeks

    Potential adverse reactions to the treatment. Participants will be asked to report and rate

  2. Adverse events

    Time frame: Baseline to 8 months

    Potential adverse reactions to the treatment. Participants will be asked to report and rate

  3. Adverse events

    Time frame: Baseline to 1 year and 2 months

    Potential adverse reactions to the treatment. Participants will be asked to report and rate

  4. Adverse events

    Time frame: Change over 9 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

  5. Accelerometer (Actigraf®)

    Time frame: Baseline to 8 weeks

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

  6. Accelerometer (Actigraf®)

    Time frame: Baseline to 1 year and 2 months

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

  7. Swedish Prescribed Drug Register

    Time frame: Retrospective period of 6 months at baseline

    The prescription fill-rate of cardiovascular medication (e.g., statin)will be collected and will be used to calculate the proportion of days covered (PDC) with a statin. A PDC <80% will be used to indicate nonadherence as per convention in other studies of cardiovascular medication refills.

  8. Swedish Prescribed Drug Register

    Time frame: Retrospective period from 6 months at 6 month follow up

    The prescription fill-rate of cardiovascular medication (e.g., statin)will be collected and will be used to calculate the proportion of days covered (PDC) with a statin. A PDC <80% will be

  9. Swedish Prescribed Drug Register

    Time frame: Retrospective period from 6 months at 12 month follow up

    The prescription fill-rate of cardiovascular medication (e.g., statin)will be collected and will be used to calculate the proportion of days covered (PDC) with a statin. A PDC <80% will be

  10. Working Alliance Inventory

    Time frame: 2 weeks from baseline

    Measures therapeutic alliance with the psychologist

  11. Treatment Credibility Scale

    Time frame: Measures treatment credibility

    2 weeks from baseline

  12. 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.

  13. 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

  14. Follow-up questions on health changes

    Time frame: Baseline to 8 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

  15. 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

  16. AFFS/SCL-4

    Time frame: Change over 9 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

  17. Behaviors following cardiac event questionnaire (BCEQ)

    Time frame: Change over 9 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

  18. DOSE Non-Adherence questionnaire

    Time frame: Change over 9 measurement points measured from baseline and weekly for 8 weeks during treatment

    3 items from this two domain scale measuring medical adherence designed to assess missed doses and reasons for missed doses.

Study contacts

Contact information is provided by the study sponsor or research team.

Josefin Särnholm, Lic psychologist, PhD

CONTACT

[email protected]

+ 46 852483258

Sponsors and collaborators

Lead sponsor

Karolinska Institutet

Other

Collaborators

  • Karolinska University Hospital

Registry information

Official study title

Digital Cognitive Behavioral Therapy for Cardiac Anxiety Following Acute Coronary Syndrome: a Randomized Controlled Trial Comparing CBT to a Digital Lifestyle Intervention

Acronym: ACS-CBT

Important dates

Study start
2024
Primary completion
2026
Study completion
2027
First posted
Mar 7, 2024
Registry last updated
Sep 16, 2025

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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