Brief Internet-delivered CBT After ACS
- Conditions
- Psychological TraumaAcute Coronary Syndrome
- Interventions
- Behavioral: Brief exposure-based CBT
- Registration Number
- NCT05607992
- Lead Sponsor
- Karolinska Institutet
- Brief Summary
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).
- Detailed Description
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.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 31
- (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.
- (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.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Brief exposure-based CBT Brief exposure-based CBT * 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.
- Primary Outcome Measures
Name Time Method Seattle Angina Questionnaire 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.
Percentage of enrolled participants who complete the treatment 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.
Acceptability: Client satisfaction Questionnaire Baseline to 5 weeks Treatment satisfaction, score ranging from 0 to 32, with a higher score indication more satisfaction with the treatment.
Adverse events 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 Outcome Measures
Name Time Method Cardiac anxiety questionnaire 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.
Patient Health Questionnaire-9 Baseline to 7 months Measure of depression, score ranging 0 to 27 with a higher score indicating higher level of depression
Seattle Angina Questionnaire 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.
Body Sensation Questionnaire Baseline to 7 months Fear of bodily symptoms, score ranging from 0 to 72 . Higher scores indicate more fear of body sensations.
Symptom checklist Severity and Frequency Scale (SCL, adapted to coronary artery disease) 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
Generalized Anxiety Disorder 7-item Baseline to 7 months General anxiety, score ranging from 0-21, with a higher score indicating more anxiety and worry.
Perceived stress scale 4-item Baseline to 7 months Stress reactivity. A greater score indicate more perceived stress.
The Godin Leisure-time Exercise and International Physical Activity Questionnaire 1 item on inactivity 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
Lifestyle factors: The national Board of health and Welfare questionnaire 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)
Myocardial infarction behavior questionnaire 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.
University of Toronto Atrial fibrillation Severity Scale (AFSS) 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.
The Posttraumatic Stress Disorder Checklist for DSM-5 (PCL-5 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.
12-Item Short-Form Health Survey 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
Trial Locations
- Locations (2)
Karolinska Institutet
🇸🇪Stockholm, Sweden
Karolinska University Hospital
🇸🇪Stockholm, Sweden