Brief Internet-delivered CBT After ACS

Karolinska Institute

Status: Completed

Conditions: Acute Coronary Syndrome; Psychological Trauma

Treatments: Behavioral: Brief exposure-based CBT

Study type: Interventional

Funder types: Other

Identifiers

NCT05607992

P30AG064198 (U.S. NIH Grant/Contract)

Details and patient eligibility

About

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).

Full description

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.

Enrollment: 31 patients

Sex: All

Ages: 18 to 80 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• (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.

Exclusion criteria

• (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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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31 participants in 2 patient groups

Brief exposure-based CBT

Experimental group

Description:

* Patient education: Common reactions following ACS. The role of PTS, cardiac anxiety and avoidance behavior on quality of life and physical health and health behaviors. * Labeling i.e., describe cardiac-related symptoms, thoughts, and feelings. * Imaginal exposure to reduce PTSS: Imaginal processing and revisiting of the memory of the ACS * Interoceptive exposure to physical sensations (e.g., palpitations due to physical activity) to reduce fear of these symptoms. * Gradual exposure in-vivo to avoided situations, activities and physical activity. Continuously use labeling while conducting exposure exercises. * Relapse prevention: Prevention of relapse into avoidance behaviors by identifying risk situations and encouragement of maintaining a healthy physically active lifestyle.

Treatment:

Behavioral: Brief exposure-based CBT

Waitlist control

No Intervention group

Description:

The waitlist control will be offered an opportunity to participate in the intervention after the 2-month intervention evaluation period.