Acute Coronary Syndrome, Psychological Trauma
Conditions
Keywords
Acute coronary syndrome, Posttraumatic stress disorder, Cardiac anxiety, Cognitive behavioral therapy
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.
Interventions
BEHAVIORALBrief exposure-based CBT
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.
Sponsors
Columbia University
Karolinska Institutet
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 80 Years
Healthy volunteers
No
Inclusion criteria
* (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.
Exclusion criteria
* (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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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. |
| 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'). |
| 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. |
| 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Myocardial infarction behavior questionnaire | Baseline to 8 weeks. | MI-related avoidance questionnaire behaviors developed by the research group. score ranging from 0 to 68 . Higher scores indicate more avoidance behavior. |
| Body Sensation Questionnaire | Baseline to 8 weeks | 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 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 |
| 12-Item Short-Form Health Survey | Baseline to 5 weeks | 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 |
| Generalized Anxiety Disorder 7-item | Baseline to 5 weeks. | General anxiety, score ranging from 0-21, with a higher score indicating more anxiety and worry. |
| Perceived stress scale 4-item | Baseline to 5 weeks | 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 5 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 |
| Lifestyle factors: The national Board of health and Welfare questionnaire | 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) |
| University of Toronto Atrial fibrillation Severity Scale (AFSS) | Baseline to 5 weeks | 3 item on cardiac-specific healthcare consumption. Scores ranges 0-15 with a higher score indicating more cardiac-related healthcare consumption. |
| Patient Health Questionnaire-9 | Baseline to 5 weeks | Measure of depression, score ranging 0 to 27 with a higher score indicating higher level of depression |
| Seattle Angina Questionnaire | Baseline to 5 weeks | 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. |
| The Posttraumatic Stress Disorder Checklist for DSM-5 (PCL-5 | Baseline to 5 weeks | Measure of post traumatic stress, score ranging from 0-80, with a higher score indicating more post traumatic stress. |
| Cardiac anxiety questionnaire | Baseline to 5 weeks | Measure of cardiac anxiety, fear, avoidance and attention. The score ranges between 0 and 72, with a greater score indicating elevated cardiac anxiety. |
Other
| Measure | Time frame | Description |
|---|---|---|
| Adverse events | Baseline to 3 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'). |
| AFFS/SCL-4 | Change over 5 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 |
Countries
Sweden
Outcome results
None listed