An interventional study of Brief exposure-based CBT in Psychological Trauma and Acute Coronary Syndrome, sponsored by Karolinska Institutet. Completed at 2 sites in Sweden. Open to participants aged 18 Years to 80 Years. Per ClinicalTrials.gov, last updated 2024-08-27.
Sponsored by Karolinska Institutet · Not applicable, Interventional, and Treatment
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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This study's enrollment of 31 is below the median of 200 across 869 interventional studies indexed under Acute Coronary Syndrome.
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Exclusion Criteria:
* Patient education: Common reactions following ACS. The role of PTS, cardiac anxiety and avoidance behavior on quality of life and physical health and health behaviors. * Labeling i.e., describe cardiac-related symptoms, thoughts, and feelings. * Imaginal exposure to reduce PTSS: Imaginal processing and revisiting of the memory of the ACS * Interoceptive exposure to physical sensations (e.g., palpitations due to physical activity) to reduce fear of these symptoms. * Gradual exposure in-vivo to avoided situations, activities and physical activity. Continuously use labeling while conducting exposure exercises. * Relapse prevention: Prevention of relapse into avoidance behaviors by identifying risk situations and encouragement of maintaining a healthy physically active lifestyle.
Behavioral: Brief exposure-based CBT
The waitlist control will be offered an opportunity to participate in the intervention after the 2-month intervention evaluation period.
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.
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.
Time frame: 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.
Time frame: 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.
Time frame: 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').
Time frame: Baseline to 5 weeks
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.
Time frame: Baseline to 5 weeks
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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: Baseline to 7 months
Perceived stress scale 4-item
Stress reactivity. A greater score indicate more perceived stress.
Time frame: Baseline to 5 weeks
Perceived stress scale 4-item
Stress reactivity. A greater score indicate more perceived stress.
Time frame: Baseline to 3 months
Perceived stress scale 4-item
Stress reactivity. A greater score indicate more perceived stress.
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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)
Time frame: 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)
Time frame: 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)
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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').
Time frame: Baseline to 3 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').
Time frame: 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').
Time frame: 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
Time frame: Change over 5 measurement points measured from baseline and weekly for 8 weeks during treatment ]
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