Online CBT Targeting Cardiac Anxiety
Conditions
Keywords
Myocardial infarction, Cardiac Anxiety, internet-CBT, Secondary prevention
Brief summary
The purpose of the present study is to evaluate an internet-delivered exposure-based cognitive behavioral therapy (CBT) protocol tailored for patients following myocardial infaction (MI) to increase Quality of Life (Qol) and physical activity by reducing cardiac anxiety.
Detailed description
In the present research project, the investigators have tailored a CBT protocol to target the hypothesized mechanisms of how cardiac anxiety affects the clinical course of MI; by using exposure therapy to reduce fear, hypervigilance, and misinterpretations of cardiac symptoms to reduce MI-related avoidance and increasing physical activity. Participants (estimated N=100) are randomized to internet-delivered CBT for 8 weeks or to a waitlist offered treatment as usual. Patients in the control arm will be crossed over to CBT treatment 3 months after the experimental group has completed treatment. Assessments will be conducted pre-treatment, post-treatment, 3 months (primary endpoint), 1-, 2 - and 5 years after treatment. These measurement points will also include the control group as it is crossed over to CBT after the 3-month follow-up
Interventions
BEHAVIORALMI-CBT
* Education Common reactions following MI and general lifestyle advice on e.g., physical activity. The role of cardiac anxiety and avoidance behavior on quality of life and physical health. Brief training in self-observation. * Goal setting Identifying life areas impaired by MI-related disability or symptom fear. Set health behavioral goals i.e., increased physical activity and gradually take steps towards them. * Exposure therapy 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. * Relapse prevention Prevention of relapse into avoidance behaviors by identifying risk situations and conduct a plan forward on maintaining a healthy physically and active lifestyle.
Sponsors
Swedish Heart Lung Foundation
The Swedish Research Council
Sahlgrenska University Hospital
Karolinska Institutet
Study design
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 80 Years
Healthy volunteers
No
Inclusion criteria
* Inclusion criteria: * Myocardial infarction ≥ 6 months before assessment (type 1 STEMI/NSTEMI) * Age 18-80 years; * Clinically significant cardiac anxiety that leads to severe distress and/or interferes with daily life * On adequate medical treatment(21); (E) Able to read and write in Swedish.
Exclusion criteria
* heart failure with severe systolic dysfunction (ejection fraction ≤ 35%) * Significant valvular disease * Planned coronary artery bypass surgery or percutaneous interventions * Any medical restriction to physical exercise * Severe medical illness * Grade 3 hypertension (i.e., blood pressure ≥ 180 systolic and/or 110 diastolic) * Severe psychiatric disorder or risk of suicide * Alcohol dependency * Ongoing psychological treatment.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Seattle Angina Questionnaire | From baseline to 5 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| 12-Item Short-Form Health Survey | From baseline to 8 weeks | General quality of life, with a score ranging from 0 to 100. A higher score indicating a better quality of life |
| Cardiac anxiety questionnaire | From baseline to 8 weeks | Measure of cardiac anxiety, fear, avoidance and attention. The score ranges between 0 and 72, with a greater score indicating elevated cardiac anxiety. |
| Myocardial infarction behavior questionnaire | From baseline to 8 weeks | MI-related avoidance questionnaire behaviors developed by the research group |
| Body Sensation Questionnaire | From 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) | 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 |
| 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 |
| Generalized Anxiety Disorder 7-item | From Baseline to 8 weeks | General anxiety, score ranging from 0-21, with a higher score indicating more anxiety and worry. |
| Perceived stress scale 4-item | Baseline to 8 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 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. |
| Healthcare consumption and work loss:Tic-P | From baseline to 8 weeks | The Trimbos and Institute of Medical Technology Assessment Cost Questionnaire for Psychiatry assesses societal cost during the last month. These costs include the participant's health care consumption (direct medical costs), time spent in other health promoting activities (direct non-medical costs), and sick leave, unemployment, and reduced work capacity at work and in the domestic realm (indirect non-medical costs). |
| University of Toronto Atrial fibrillation Severity Scale (AFSS) | From 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. |
| Seattle Angina Questionnaire | From baseline to 8 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. |
Other
| Measure | Time frame | Description |
|---|---|---|
| Accelerometer (Actigraf®) | Baseline to 8 weeks | An Accelerometer (Actigraf®) will be carried on the wrist over to measure physical activity over 1 week |
| Adverse events | From Baseline to 8 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'). |
| 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. |
| Treatment Credibility Scale | 1-2 weeks from baseline | Measures treatment credibility |
| Working Alliance Inventory | 1-2 weeks from baseline | Measures therapeutic alliance with the psychologist |
| 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 8 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 |
| MI-behavior Questionnaire | Change over 8 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 |
| Perceived stress scale 4-item | Change over 8 measurement points measured from baseline and weekly for 8 weeks during treatment | Measure of perceived stress and stress reactivity. Score ranging 0 -16 with a higher score indicating more perceived stress. |
| Algometry (Somedic AB, Hörby, Sweden) | From Baseline to 8 weeks | A pain sensitivity measurement with algometry (Somedic AB, Hörby, Sweden); consisting of a handle with a 1 cm rubber plate at the end will be used. Algometers are used to measure pressure pain thresholds, the exact pressure (kPa) is registered in the algometer and thus a measure of a person's pain threshold can be assessed. |
| Number of Participants With Abnormal Laboratory Values | From Baseline to 8 weeks | Venous blood will be collected for local analyses of fasting plasma glucose, HbA1c, plasma total cholesterol, LDL, HDL, triglycerides, hsCRP, creatinine, stress-related hormones such as cortisol, copeptin and vasopressin |
Countries
Sweden
Outcome results
None listed