Acute Coronary Syndrome, Online CBT Targeting Cardiac Anxiety
Conditions
Keywords
Cardiac Anxiety, Acute Coronary Syndrome, ACS, Internet-CBT, CBT, Secondary prevention
Brief summary
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.
Detailed description
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.
Interventions
BEHAVIORALInternet-CBT
* Common reactions following ACS. The role of cardiac anxiety and avoidance behavior on quality of life and physical health. Brief training in self-observation, i.e., labeling. General lifestyle advice on e.g., physical activity, diet. * Identifying life areas impaired by ACS-related disability or symptom fear. Set health behavioral goals i.e., increased physical activity and gradually take steps towards them. * Gradual exposure to physical sensations (e.g., palpitations due to physical activity) to reduce fear of these symptoms. * Gradual exposure to avoided situations, activities and increase in physical activity. * Prevention of relapse into avoidance behaviors by identifying risk situations and conduct a plan forward on maintaining a healthy physically and active lifestyle.
BEHAVIORALInternet-CL
* Education on ACS, risk factors, its treatments and medication. * Education and advice promoting healthy habits regarding diet, alcohol and tobacco. * Education and advice regarding physical activity and the beneficial effects on health. * Education regarding common emotional reactions following ACS. * Prevention of relapse and plan forward to maintain a healthy lifestyle.
Sponsors
Karolinska University Hospital
Karolinska Institutet
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Subject)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* ACS ≥ 6 months before assessment (type 1 MI STEMI/NSTEMI or unstable angina \[UA\]) * Age 18 and older * Clinically significant cardiac anxiety that leads to distress and/or interferes with daily life (Cardiac Anxiety Questionnaire; CAQ: ≥18 * Able to read and write in Swedish
Exclusion criteria
* Heart failure New York heart Association class IV or ejection fraction ≤ 30% * Significant valvular disease * Planned coronary artery bypass surgery or percutaneous interventions * Any medical restriction to physical exercise * Severe medical illness or an acute health threatening disease (e.g., cancer) * Grade 3 hypertension (i.e., blood pressure ≥ 180 systolic and/or 110 diastolic) * Severe mental illness requiring urgent psychiatric hospitalization or intervention, or risk of suicide * Alcohol or substance use disorder that would impede ability to complete study protocol * Ongoing psychological treatment
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Cardiac anxiety questionnaire modified for weekly assessment | Change over 9 measurement points measured from baseline and weekly for 8 weeks during treatment [PRIMARY ENDPOINT] | Measure of cardiac anxiety, fear, avoidance and attention. The score ranges between 0 and 72, with a greater score indicating elevated cardiac anxiety. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Symptom checklist Severity and Frequency Scale (SCL, adapted to coronary artery disease) modified for weekly assessment | From 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 |
| Behaviors following cardiac event questionnaire (BCEQ) | From baseline to 8 weeks | MI-related avoidance questionnaire behaviors developed by the research group |
| DOSE Non-Adherence questionnaire | From baseline to 8 weeks | 3 items from this two domain scale measuring medical adherence designed to assess missed doses and reasons for missed doses. |
| Perceived stress scale 4-item | Baseline to 8 weeks | Stress reactivity. A greater score indicate more perceived stress. |
| Short Fatigue questionnaire | From baseline to 8 weeks | 4-item scale measuring fatigue. |
| Patient Health Questionnaire-9 | From Baseline to 8 weeks | Measure of depression, score ranging 0 to 27 with a higher score indicating higher level of depression |
| Insomnia Severity Index | From Baseline to 8 weeks | Measurement of the degree of sleep difficulties. The total score can range from 0 to 28 points. Higher scores indicate more severe sleep difficulties. |
| The Godin Leisure-time Exercise and International Physical Activity Questionnaire 1 item on inactivity | Baseline to 8 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) and BMI. |
| Aversive cognition to medication | Baseline to 8 weeks | : A 3-item subset of questions with regards to psychological distress associated with cardiac medication |
| Adversive cognition to medication | Baseline to 8 months | : A 3-item subset of questions with regards to psychological distress associated with cardiac medication |
| Cardiac anxiety questionnaire | From baseline to 8 months | Measure of cardiac anxiety, fear, avoidance and attention. The score ranges between 0 and 72, with a greater score indicating elevated cardiac anxiety. |
| HeartQoL Health-related Quality of Life Questionnaire modified for weekly assessment | Change over 9 measurement points measured from baseline and weekly for 8 weeks during treatment | 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. |
| HeartQoL Health-related Quality of Life Questionnaire | From baseline to 8 months | 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. |
| Symptom checklist Severity and Frequency Scale (SCL, adapted to coronary artery disease) | From baseline to 8 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 |
| University of Toronto Atrial fibrillation Severity Scale (AFSS) | Baseline to 8 weeks | 3 item on cardiac-specific healthcare consumption. Scores ranges 0-15 with a higher score indicating more cardiac-related healthcare consumption |
Other
| Measure | Time frame | Description |
|---|---|---|
| Swedish Prescribed Drug Register | Retrospective period of 6 months at baseline | 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. |
| Working Alliance Inventory | 2 weeks from baseline | Measures therapeutic alliance with the psychologist |
| Treatment Credibility Scale | Measures treatment credibility | 2 weeks from baseline |
| Client satisfaction Questionnaire | Baseline to 8 weeks | Treatment satisfaction, score ranging from 0 to 32, with a higher score indication more satisfaction with the treatment. |
| Follow-up questions on health changes | Baseline to 8 weeks | 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 |
| AFFS/SCL-4 | Change over 9 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 |
| Behaviors following cardiac event questionnaire (BCEQ) | Change over 9 measurement points measured from baseline and weekly for 8 weeks during treatment | 5 items measuring avoidance behavior from the MI-related avoidance questionnaire behaviors developed by the research group |
| DOSE Non-Adherence questionnaire | Change over 9 measurement points measured from baseline and weekly for 8 weeks during treatment | 3 items from this two domain scale measuring medical adherence designed to assess missed doses and reasons for missed doses. |
| Accelerometer (Actigraf®) | Baseline to 8 weeks | n Accelerometer (Actigraf®) will be carried on the wrist over to measure physical activity over 1 week |
| Adverse events | Baseline to 8 weeks | Potential adverse reactions to the treatment. Participants will be asked to report and rate |
Countries
Sweden
Contacts
Primary ContactJosefin Särnholm, Lic psychologist, PhD
Outcome results
None listed