Brief Internet-delivered Exposure-based Therapy to Reduce Post-traumatic Stress Symptoms and Cardiac Anxiety After Acute Coronary Syndrome: a Pilot Randomized Clinical Trial
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 31
- 试验地点
- 3
- 主要终点
- Seattle Angina Questionnaire
研究概览
简要总结
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).
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 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
- •(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.
排除标准
- •(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.
结局指标
主要结局
Seattle Angina Questionnaire
时间窗: 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
时间窗: 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
时间窗: Baseline to 5 weeks
Treatment satisfaction, score ranging from 0 to 32, with a higher score indication more satisfaction with the treatment.
Adverse events
时间窗: 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').
次要结局
- Cardiac anxiety questionnaire(Change over 5 measurement points measured from baseline and weekly for 5 weeks during treatment)
- Patient Health Questionnaire-9(Baseline to 7 months)
- Seattle Angina Questionnaire(Change over 5 measurement points measured from baseline and weekly for 5 weeks during treatment)
- Body Sensation Questionnaire(Baseline to 7 months)
- Symptom checklist Severity and Frequency Scale (SCL, adapted to coronary artery disease)(Baseline to 7 months)
- Generalized Anxiety Disorder 7-item(Baseline to 7 months)
- Perceived stress scale 4-item(Baseline to 7 months)
- The Godin Leisure-time Exercise and International Physical Activity Questionnaire 1 item on inactivity(Baseline to 7 months)
- Lifestyle factors: The national Board of health and Welfare questionnaire(Baseline to 7 months)
- Myocardial infarction behavior questionnaire(Baseline to 7 months)
- University of Toronto Atrial fibrillation Severity Scale (AFSS)(Baseline to 7 months)
- 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)
- 12-Item Short-Form Health Survey(Baseline to 7 months)
研究者
Josefin Särnholm
Principal Investigator, PhD, Lic. psychologist
Karolinska Institutet