Internet-based Behavioral Intervention Following ACS

Официальное название

Digital Cognitive Behavioral Therapy for Cardiac Anxiety Following Acute Coronary Syndrome: a Randomized Controlled Trial Comparing CBT to a Digital Lifestyle Intervention

Обзор

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.

Подробное описание

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.

Вмешательства

• Поведенческое Internet-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
• Поведенческое Internet-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.

Первичные конечные точки

• Cardiac anxiety questionnaire modified for weekly assessment [Срок оценки: Change over 9 measurement points measured from baseline and weekly for 8 weeks during treatment [PRIMARY ENDPOINT]]

Вторичные конечные точки (12)

• Cardiac anxiety questionnaire [Срок оценки: From baseline to 8 months]
• Cardiac anxiety questionnaire [Срок оценки: From baseline to 1 year and 2 months]
• HeartQoL Health-related Quality of Life Questionnaire modified for weekly assessment [Срок оценки: Change over 9 measurement points measured from baseline and weekly for 8 weeks during treatment]
• HeartQoL Health-related Quality of Life Questionnaire [Срок оценки: From baseline to 8 months]
• HeartQoL Health-related Quality of Life Questionnaire [Срок оценки: From baseline to 1 year and 2 months]
• Symptom checklist Severity and Frequency Scale (SCL, adapted to coronary artery disease) modified for weekly assessment [Срок оценки: From baseline to 8 weeks]
• Symptom checklist Severity and Frequency Scale (SCL, adapted to coronary artery disease) [Срок оценки: From baseline to 8 months]
• Symptom checklist Severity and Frequency Scale (SCL, adapted to coronary artery disease) [Срок оценки: From baseline to 1 year and 2 months]
• University of Toronto Atrial fibrillation Severity Scale (AFSS) [Срок оценки: Baseline to 8 weeks]
• University of Toronto Atrial fibrillation Severity Scale (AFSS) [Срок оценки: From baseline to 8 months]
• University of Toronto Atrial fibrillation Severity Scale (AFSS) [Срок оценки: From baseline to 1 year and 2 months]
• Behaviors following cardiac event questionnaire (BCEQ) [Срок оценки: From baseline to 8 weeks]

Критерии участия

Критерии включения

• 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

Критерии исключения

• 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

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Рандомизированное

Модель

Параллельные группы

Маскирование

Простое слепое

Основная цель

Лечение

Центры проведения

Швеция · 1 центр

• Karolinska University Hospital — Stockholm

Публикации

• Johnsson A, Ljotsson B, Braunschweig F, Mellbin LG, Sarnholm J. Digital cognitive behavioural therapy for cardiac anxiety following acute coronary syndrome: protocol for a randomised controlled trial comparing CBT to a digital lifestyle intervention. BMJ Open. 2025 Oct 28;15(10):e106473. doi: 10.1136/bmjopen-2025-106473. PMID 41151962

Идентификаторы

NCT: NCT06298864 · ASC-RCT 2

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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