Internet-based Behavioral Intervention Following ACS

NCT06298864 | Recruiting

• 1 other identifier: ASC-RCT 2
• Study Type: interventional
• Target: 176
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Acute Coronary Syndrome; Online CBT Targeting Cardiac Anxiety

Keywords

Cardiac Anxiety; Acute Coronary Syndrome; ACS; Internet-CBT; CBT; Secondary prevention

Outcome Measures

Primary Outcomes (1)

• Cardiac anxiety questionnaire modified for weekly assessment

  Measure of cardiac anxiety, fear, avoidance and attention. The score ranges between 0 and 72, with a greater score indicating elevated cardiac anxiety.

  Change over 9 measurement points measured from baseline and weekly for 8 weeks during treatment [PRIMARY ENDPOINT]

Secondary Outcomes (39)

• Cardiac anxiety questionnaire

  From baseline to 8 months

• Cardiac anxiety questionnaire

  From baseline to 1 year and 2 months

• HeartQoL Health-related Quality of Life Questionnaire modified for weekly assessment

  Change over 9 measurement points measured from baseline and weekly for 8 weeks during treatment

• HeartQoL Health-related Quality of Life Questionnaire

  From baseline to 8 months

• HeartQoL Health-related Quality of Life Questionnaire

  From baseline to 1 year and 2 months

Other Outcomes (18)

• Adverse events

  Baseline to 8 weeks

• Adverse events

  Baseline to 8 months

• Adverse events

  Baseline to 1 year and 2 months

Study Arms (2)

Internet-based Cognitive Behavioral Therapy (Internet-CBT)

EXPERIMENTAL

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.

Behavioral: Internet-CBT

Internet-based Cardiac Lifestyle intervention (Internet-CL)

ACTIVE COMPARATOR

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.

Behavioral: Internet-CL

Interventions

Internet-CBT BEHAVIORAL

* 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) to reduce fear of these symptoms. * Gradual exposure to avoided situations, activities and increase in physical activity. * Prevention of relapse into avoidance behaviors by identifying risk situations and conduct a plan forward on maintaining a healthy physically and active lifestyle.

Internet-based Cognitive Behavioral Therapy (Internet-CBT)

Internet-CL BEHAVIORAL

* 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.

Internet-based Cardiac Lifestyle intervention (Internet-CL)

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Karolinska Institutet: lead
• Karolinska University Hospital: collaborator

Study Sites (1)

Karolinska University Hospital

Stockholm, 11635, Sweden

RECRUITING

Related Publications (1)

• 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 DERIVED

MeSH Terms

Conditions

Acute Coronary Syndrome

Condition Hierarchy (Ancestors)

Myocardial Ischemia; Heart Diseases; Cardiovascular Diseases; Vascular Diseases

Central Study Contacts

Josefin Särnholm, Lic psychologist, PhD

CONTACT

+ 46 852483258; josefin.sarnholm@ki.se

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: PhD, Lic. Psychologist

Study Record Dates

• First Submitted: February 26, 2024
• First Posted: March 7, 2024
• Study Start: March 7, 2024
• Primary Completion (Estimated): October 31, 2026
• Study Completion (Estimated): October 31, 2027
• Last Updated: September 16, 2025

Record last verified: 2025-09

Data Sharing

• IPD Sharing: Will not share

Locations

SE (1)