Internet-based Behavioral Intervention Following ACS (ACS-CBT)

Karolinska Institute

Status: Enrolling

Conditions: Acute Coronary Syndrome; Online CBT Targeting Cardiac Anxiety

Treatments: Behavioral: Internet-CBT; Behavioral: Internet-CL

Study type: Interventional

Funder types: Other

Identifiers

NCT06298864

ASC-RCT 2

Details and patient eligibility

About

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.

Full 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.

Enrollment: 176 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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176 participants in 2 patient groups

Internet-based Cognitive Behavioral Therapy (Internet-CBT)

Experimental group

Description:

Internet-CBT following ACS is exposure-based, centering on exposure to cardiac related symptoms and situations. The CBT is therapist-guided and lasts for 8 weeks.

Treatment:

Behavioral: Internet-CBT

Internet-based Cardiac Lifestyle intervention (Internet-CL)

Active Comparator group

Description:

Internet-CL is based on strategies for behavioral change and guidelines on health promoting lifestyle modifications following ACS. The Internet-CL is therapist-guided and lasts for 8 weeks.

Treatment:

Behavioral: Internet-CL