Online Cognitive Behavioral Therapy Targeting Cardiac Anxiety Following Myocardial Infarction: A Randomized Controlled Trial
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 入组人数
- 96
- 试验地点
- 2
- 主要终点
- Seattle Angina Questionnaire
研究概览
简要总结
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.
详细描述
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
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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.
排除标准
- •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.
结局指标
主要结局
Seattle Angina Questionnaire
时间窗: 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.
次要结局
- Body Sensation Questionnaire(From baseline to 5 years and 2 months)
- Cardiac anxiety questionnaire(From baseline to 5 year and 2 months)
- Symptom checklist Severity and Frequency Scale (SCL, adapted to coronary artery disease)(From baseline to 5 years and 2 months)
- Seattle Angina Questionnaire(From baseline to 5 years and 2 months)
- Perceived stress scale 4-item(Baseline to 5 years and 2 months)
- Generalized Anxiety Disorder 7-item(From Baseline to 5 years and 2 months)
- 12-Item Short-Form Health Survey(From baseline to 5 year and 2 months)
- Myocardial infarction behavior questionnaire(From baseline to 5 years and 2 months)
- Lifestyle factors: The national Board of health and Welfare questionnaire(Baseline to 5 years and 2 months)
- Healthcare consumption and work loss:Tic-P(From baseline to 5 years and 2 months)
- Patient Health Questionnaire-9(From Baseline to 5 years and 2 months)
- The Godin Leisure-time Exercise and International Physical Activity Questionnaire 1 item on inactivity(Baseline to 5 years and 2 months)
- University of Toronto Atrial fibrillation Severity Scale (AFSS)(From Baseline to 5 years and 2 months)
研究者
Josefin Särnholm
Principal Investigator, PhD
Karolinska Institutet