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| Name | Class |
|---|---|
| Karolinska University Hospital | OTHER |
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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Internet-based Cognitive Behavioral Therapy (Internet-CBT) | Experimental | Internet-CBT following ACS is exposure-based, centering on exposure to cardiac related symptoms and situations. The CBT is therapist-guided and lasts for 8 weeks. |
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| Internet-based Cardiac Lifestyle intervention (Internet-CL) | Active Comparator | Internet-CL is based on strategies for behavioral change and guidelines on health promoting lifestyle modifications following ACS. The Internet-CL is therapist-guided and lasts for 8 weeks. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Internet-CBT | Behavioral |
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| Measure | Description | Time Frame |
|---|---|---|
| Cardiac anxiety questionnaire modified for weekly assessment | Measure of cardiac anxiety, fear, avoidance and attention. The score ranges between 0 and 72, with a greater score indicating elevated cardiac anxiety. | Change over 9 measurement points measured from baseline and weekly for 8 weeks during treatment [PRIMARY ENDPOINT] |
| Measure | Description | Time Frame |
|---|---|---|
| Cardiac anxiety questionnaire | Measure of cardiac anxiety, fear, avoidance and attention. The score ranges between 0 and 72, with a greater score indicating elevated cardiac anxiety. | From baseline to 8 months |
| Cardiac anxiety questionnaire |
| Measure | Description | Time Frame |
|---|---|---|
| Adverse events | Potential adverse reactions to the treatment. Participants will be asked to report and rate | Baseline to 8 weeks |
| Adverse events | Potential adverse reactions to the treatment. Participants will be asked to report and rate |
Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Josefin Särnholm, Lic psychologist, PhD | Contact | + 46 852483258 | josefin.sarnholm@ki.se |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Karolinska University Hospital | Recruiting | Stockholm | 11635 | Sweden |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 41151962 | Derived | Johnsson A, Ljotsson B, Braunschweig F, Mellbin LG, Sarnholm J. Digital cognitive behavioural therapy for cardiac anxiety following acute coronary syndrome: protocol for a randomised controlled trial comparing CBT to a digital lifestyle intervention. BMJ Open. 2025 Oct 28;15(10):e106473. doi: 10.1136/bmjopen-2025-106473. |
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The individual participant data underlying the analyses in this study cannot be made publicly available due to Swedish and European Union data protection regulations. Requests for additional outcomes or estimates may be directed to the corresponding author and will be handled in accordance with legal expertise and the sponsor's current data governance guidelines
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| ID | Term |
|---|---|
| D054058 | Acute Coronary Syndrome |
| ID | Term |
|---|---|
| D017202 | Myocardial Ischemia |
| D006331 | Heart Diseases |
| D002318 | Cardiovascular Diseases |
| D014652 | Vascular Diseases |
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| Internet-CL | Behavioral |
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Measure of cardiac anxiety, fear, avoidance and attention. The score ranges between 0 and 72, with a greater score indicating elevated cardiac anxiety.
| From baseline to 1 year and 2 months |
| HeartQoL Health-related Quality of Life Questionnaire modified for weekly assessment | 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. | Change over 9 measurement points measured from baseline and weekly for 8 weeks during treatment |
| HeartQoL Health-related Quality of Life Questionnaire | 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. | From baseline to 8 months |
| HeartQoL Health-related Quality of Life Questionnaire | 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. | From baseline to 1 year and 2 months |
| Symptom checklist Severity and Frequency Scale (SCL, adapted to coronary artery disease) modified for weekly assessment | 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 | From baseline to 8 weeks |
| Symptom checklist Severity and Frequency Scale (SCL, adapted to coronary artery disease) | 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 | From baseline to 8 months |
| Symptom checklist Severity and Frequency Scale (SCL, adapted to coronary artery disease) | 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 | From baseline to 1 year and 2 months |
| University of Toronto Atrial fibrillation Severity Scale (AFSS) | 3 item on cardiac-specific healthcare consumption. Scores ranges 0-15 with a higher score indicating more cardiac-related healthcare consumption | Baseline to 8 weeks |
| University of Toronto Atrial fibrillation Severity Scale (AFSS) | 3 item on cardiac-specific healthcare consumption. Scores ranges 0-15 with a higher score indicating more cardiac-related healthcare consumption | From baseline to 8 months |
| University of Toronto Atrial fibrillation Severity Scale (AFSS) | 3 item on cardiac-specific healthcare consumption. Scores ranges 0-15 with a higher score indicating more cardiac-related healthcare consumption | From baseline to 1 year and 2 months |
| Behaviors following cardiac event questionnaire (BCEQ) | MI-related avoidance questionnaire behaviors developed by the research group | From baseline to 8 weeks |
| Behaviors following cardiac event questionnaire (BCEQ) | MI-related avoidance questionnaire behaviors developed by the research group | From baseline to 8 months |
| Behaviors following cardiac event questionnaire (BCEQ) | MI-related avoidance questionnaire behaviors developed by the research group | From baseline to 1 year and 2 months |
| DOSE Non-Adherence questionnaire | 3 items from this two domain scale measuring medical adherence designed to assess missed doses and reasons for missed doses. | From baseline to 8 weeks |
| DOSE Non-Adherence questionnaire | 3 items from this two domain scale measuring medical adherence designed to assess missed doses and reasons for missed doses. | From baseline to 8 months |
| DOSE Non-Adherence questionnaire | 3 items from this two domain scale measuring medical adherence designed to assess missed doses and reasons for missed doses. | From baseline to 1 year and 2 months |
| Perceived stress scale 4-item | Stress reactivity. A greater score indicate more perceived stress. | Baseline to 8 weeks |
| Perceived stress scale 4-item | Stress reactivity. A greater score indicate more perceived stress. | Baseline to 8 months |
| Perceived stress scale 4-item | Stress reactivity. A greater score indicate more perceived stress. | Baseline to 1 year and 2 months |
| Short Fatigue questionnaire | 4-item scale measuring fatigue. | From baseline to 8 weeks |
| Short Fatigue questionnaire | 4-item scale measuring fatigue. | Baseline to 8 months |
| Short Fatigue questionnaire | 4-item scale measuring fatigue. | Baseline to 1 year and 2 months |
| Patient Health Questionnaire-9 | Measure of depression, score ranging 0 to 27 with a higher score indicating higher level of depression | From Baseline to 8 weeks |
| Patient Health Questionnaire-9 | Measure of depression, score ranging 0 to 27 with a higher score indicating higher level of depression | From Baseline to 8 months |
| Patient Health Questionnaire-9 | Measure of depression, score ranging 0 to 27 with a higher score indicating higher level of depression | From Baseline to 1 year and 2 months |
| Insomnia Severity Index | Measurement of the degree of sleep difficulties. The total score can range from 0 to 28 points. Higher scores indicate more severe sleep difficulties. | From Baseline to 8 weeks |
| Insomnia Severity Index | Measurement of the degree of sleep difficulties. The total score can range from 0 to 28 points. Higher scores indicate more severe sleep difficulties. | From Baseline to 8 months |
| Insomnia Severity Index | Measurement of the degree of sleep difficulties. The total score can range from 0 to 28 points. Higher scores indicate more severe sleep difficulties. | From Baseline to 1 year and 2 months |
| Perceived stress scale 4-item | Stress reactivity. A greater score indicate more perceived stress. | Change over 9 measurement points measured from baseline and weekly for 8 weeks during treatment |
| The Godin Leisure-time Exercise and International Physical Activity Questionnaire 1 item on inactivity | 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 | Baseline to 8 weeks |
| The Godin Leisure-time Exercise and International Physical Activity Questionnaire 1 item on inactivity | 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 | Baseline to 8 months |
| The Godin Leisure-time Exercise and International Physical Activity Questionnaire 1 item on inactivity | 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 | Baseline to 1 year and 2 months |
| Lifestyle factors: The national Board of health and Welfare questionnaire | Questionnaire regarding diet (5 item), tobacco (2 item) and alcohol (3 item) diet (5 item), tobacco (2 item) and alcohol (3 item) and BMI. | Baseline to 8 weeks |
| Lifestyle factors: The national Board of health and Welfare questionnaire | Questionnaire regarding diet (5 item), tobacco (2 item) and alcohol (3 item) diet (5 item), tobacco (2 item) and alcohol (3 item) and BMI. | Baseline to 8 months |
| Lifestyle factors: The national Board of health and Welfare questionnaire | Questionnaire regarding diet (5 item), tobacco (2 item) and alcohol (3 item) diet (5 item), tobacco (2 item) and alcohol (3 item) and BMI. | Baseline to 1 year and 2 months |
| Aversive cognition to medication | : A 3-item subset of questions with regards to psychological distress associated with cardiac medication | Baseline to 8 weeks |
| Adversive cognition to medication | : A 3-item subset of questions with regards to psychological distress associated with cardiac medication | Baseline to 8 months |
| Adversive cognition to medication | : A 3-item subset of questions with regards to psychological distress associated with cardiac medication | Baseline to 1 year and 2 months |
| Baseline to 8 months |
| Adverse events | Potential adverse reactions to the treatment. Participants will be asked to report and rate | Baseline to 1 year and 2 months |
| Adverse events | Potential adverse reactions to the treatment. Participants will be asked to report and rate | Change over 9 measurement points measured from baseline and weekly for 8 weeks during treatment |
| Accelerometer (Actigraf®) | n Accelerometer (Actigraf®) will be carried on the wrist over to measure physical activity over 1 week | Baseline to 8 weeks |
| Accelerometer (Actigraf®) | n Accelerometer (Actigraf®) will be carried on the wrist over to measure physical activity over 1 week | Baseline to 1 year and 2 months |
| Swedish Prescribed Drug Register | 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. | Retrospective period of 6 months at baseline |
| Swedish Prescribed Drug Register | 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 | Retrospective period from 6 months at 6 month follow up |
| Swedish Prescribed Drug Register | 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 | Retrospective period from 6 months at 12 month follow up |
| Working Alliance Inventory | Measures therapeutic alliance with the psychologist | 2 weeks from baseline |
| Treatment Credibility Scale | 2 weeks from baseline | Measures treatment credibility |
| Client satisfaction Questionnaire | Treatment satisfaction, score ranging from 0 to 32, with a higher score indication more satisfaction with the treatment. | Baseline to 8 weeks |
| Follow-up questions on health changes | 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 | Baseline to 8 weeks |
| Follow-up questions on health changes | 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 | Baseline to 8 months |
| Follow-up questions on health changes | 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 | Baseline to 1 year and 2 months |
| AFFS/SCL-4 | 4 items derived from the Symptoms Checklist (SCL) and the Atrial Fibrillation Severity Scale (AFSS) measuring disabling cardiac symptoms | Change over 9 measurement points measured from baseline and weekly for 8 weeks during treatment |
| Behaviors following cardiac event questionnaire (BCEQ) | 5 items measuring avoidance behavior from the MI-related avoidance questionnaire behaviors developed by the research group | Change over 9 measurement points measured from baseline and weekly for 8 weeks during treatment |
| DOSE Non-Adherence questionnaire | 3 items from this two domain scale measuring medical adherence designed to assess missed doses and reasons for missed doses. | Change over 9 measurement points measured from baseline and weekly for 8 weeks during treatment |