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| Name | Class |
|---|---|
| Columbia University | OTHER |
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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).
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Brief exposure-based CBT | Experimental |
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| Waitlist control | No Intervention | The waitlist control will be offered an opportunity to participate in the intervention after the 2-month intervention evaluation period. |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 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. |
| Measure | Description | Time Frame |
|---|---|---|
| Seattle Angina Questionnaire | 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. | Baseline to 3 months |
| Acceptability: Client satisfaction Questionnaire | Treatment satisfaction, score ranging from 0 to 32, with a higher score indication more satisfaction with the treatment. | Baseline to 5 weeks |
| Percentage of enrolled participants who complete the treatment | 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. | Baseline to 5 weeks |
| Adverse events | 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'). | Baseline to 5 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Seattle Angina Questionnaire | 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. | Baseline to 5 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Adverse events | 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'). | Baseline to 3 months |
| Adverse events |
Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Karolinska University Hospital | Stockholm | 11635 | Sweden | |||
| Karolinska Institutet |
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| Type | Date | Date Unknown |
|---|---|---|
| Release | Jul 3, 2025 | |
| Reset | Jul 22, 2025 |
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| Release Date | Unrelease Date | Unrelease Date Unknown | Reset Date | MCP Release Number |
|---|---|---|---|---|
| Jul 3, 2025 | Jul 22, 2025 |
| ID | Term |
|---|---|
| D000067073 | Psychological Trauma |
| D054058 | Acute Coronary Syndrome |
| D013313 | Stress Disorders, Post-Traumatic |
| ID | Term |
|---|---|
| D040921 | Stress Disorders, Traumatic |
| D000068099 | Trauma and Stressor Related Disorders |
| D001523 | Mental Disorders |
| D017202 | Myocardial Ischemia |
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| Seattle Angina Questionnaire |
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. |
| Baseline to 7 months |
| Seattle Angina Questionnaire | 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. | Change over 5 measurement points measured from baseline and weekly for 5 weeks during treatment |
| The Posttraumatic Stress Disorder Checklist for DSM-5 (PCL-5 | Measure of post traumatic stress, score ranging from 0-80, with a higher score indicating more post traumatic stress. | Baseline to 5 weeks |
| The Posttraumatic Stress Disorder Checklist for DSM-5 (PCL-5 | Measure of post traumatic stress, score ranging from 0-80, with a higher score indicating more post traumatic stress. | Baseline to 3 months |
| The Posttraumatic Stress Disorder Checklist for DSM-5 (PCL-5 | Measure of post traumatic stress, score ranging from 0-80, with a higher score indicating more post traumatic stress. | Baseline to 7 months |
| The Posttraumatic Stress Disorder Checklist for DSM-5 (PCL-5 | Measure of post traumatic stress, score ranging from 0-80, with a higher score indicating more post traumatic stress. | Change over 5 measurement points measured from baseline and weekly for 5 weeks during treatment |
| 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. | Baseline to 5 weeks |
| 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. | Baseline to 3 months |
| 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. | Baseline to 7 months |
| 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. | Change over 5 measurement points measured from baseline and weekly for 5 weeks during treatment |
| Myocardial infarction behavior questionnaire | MI-related avoidance questionnaire behaviors developed by the research group. score ranging from 0 to 68 . Higher scores indicate more avoidance behavior. | Baseline to 8 weeks. |
| Myocardial infarction behavior questionnaire | MI-related avoidance questionnaire behaviors developed by the research group. score ranging from 0 to 68 . Higher scores indicate more avoidance behavior. | Baseline to 3 months |
| Myocardial infarction behavior questionnaire | MI-related avoidance questionnaire behaviors developed by the research group. score ranging from 0 to 68 . Higher scores indicate more avoidance behavior. | Baseline to 7 months |
| Body Sensation Questionnaire | Fear of bodily symptoms, score ranging from 0 to 72 . Higher scores indicate more fear of body sensations. | Baseline to 8 weeks |
| Body Sensation Questionnaire | Fear of bodily symptoms, score ranging from 0 to 72 . Higher scores indicate more fear of body sensations. | Baseline to 3 months |
| Body Sensation Questionnaire | Fear of bodily symptoms, score ranging from 0 to 72 . Higher scores indicate more fear of body sensations. | Baseline to 7 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 | 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 | Baseline to 3 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 | Baseline to 7 months |
| 12-Item Short-Form Health Survey | 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 | Baseline to 5 weeks |
| 12-Item Short-Form Health Survey | 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 | Baseline to 3 months |
| 12-Item Short-Form Health Survey | 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 | Baseline to 7 months |
| Patient Health Questionnaire-9 | Measure of depression, score ranging 0 to 27 with a higher score indicating higher level of depression | Baseline to 5 weeks |
| Patient Health Questionnaire-9 | Measure of depression, score ranging 0 to 27 with a higher score indicating higher level of depression | Baseline to 3 months |
| Patient Health Questionnaire-9 | Measure of depression, score ranging 0 to 27 with a higher score indicating higher level of depression | Baseline to 7 months |
| Generalized Anxiety Disorder 7-item | General anxiety, score ranging from 0-21, with a higher score indicating more anxiety and worry. | Baseline to 5 weeks. |
| Generalized Anxiety Disorder 7-item | General anxiety, score ranging from 0-21, with a higher score indicating more anxiety and worry. | Baseline to 3 months |
| Generalized Anxiety Disorder 7-item | General anxiety, score ranging from 0-21, with a higher score indicating more anxiety and worry. | Baseline to 7 months |
| Perceived stress scale 4-item | Stress reactivity. A greater score indicate more perceived stress. | Baseline to 5 weeks |
| Perceived stress scale 4-item | Stress reactivity. A greater score indicate more perceived stress. | Baseline to 3 months |
| Perceived stress scale 4-item | Stress reactivity. A greater score indicate more perceived stress. | Baseline to 7 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 5 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 3 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 7 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) | 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) | Baseline to 3 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) | Baseline to 7 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 5 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. | Baseline to 3 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 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'). |
| Baseline to 7 months |
| Adverse events | 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'). | 5 measurement points measured from baseline and weekly for 5 weeks during treatment |
| AFFS/SCL-4 | 4 items derived from the Symptoms Checklist (SCL) and the Atrial Fibrillation Severity Scale (AFSS) measuring disabling cardiac symptoms | Change over 5 measurement points measured from baseline and weekly for 8 weeks during treatment ] |
| Stockholm |
| Sweden |
| D006331 | Heart Diseases |
| D002318 | Cardiovascular Diseases |
| D014652 | Vascular Diseases |