Internet-based Behavioral Intervention Following ACS
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Internet-CBT, Internet-CL.
- Who it may be relevant to
- Registry conditions: Acute Coronary Syndrome, Online CBT Targeting Cardiac Anxiety. Basic parameters: from 18 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Sweden
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Unsure about the terms? Read our patient guide →
Official title
Digital Cognitive Behavioral Therapy for Cardiac Anxiety Following Acute Coronary Syndrome: a Randomized Controlled Trial Comparing CBT to a Digital Lifestyle Intervention
Overview
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.
Detailed 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.
Interventions
- Behavioral 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 - Behavioral 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.
Primary outcome measures
- Cardiac anxiety questionnaire modified for weekly assessment [Time frame: Change over 9 measurement points measured from baseline and weekly for 8 weeks during treatment [PRIMARY ENDPOINT]]
Secondary outcome measures (12)
- Cardiac anxiety questionnaire [Time frame: From baseline to 8 months]
- Cardiac anxiety questionnaire [Time frame: From baseline to 1 year and 2 months]
- HeartQoL Health-related Quality of Life Questionnaire modified for weekly assessment [Time frame: Change over 9 measurement points measured from baseline and weekly for 8 weeks during treatment]
- HeartQoL Health-related Quality of Life Questionnaire [Time frame: From baseline to 8 months]
- HeartQoL Health-related Quality of Life Questionnaire [Time frame: From baseline to 1 year and 2 months]
- Symptom checklist Severity and Frequency Scale (SCL, adapted to coronary artery disease) modified for weekly assessment [Time frame: From baseline to 8 weeks]
- Symptom checklist Severity and Frequency Scale (SCL, adapted to coronary artery disease) [Time frame: From baseline to 8 months]
- Symptom checklist Severity and Frequency Scale (SCL, adapted to coronary artery disease) [Time frame: From baseline to 1 year and 2 months]
- University of Toronto Atrial fibrillation Severity Scale (AFSS) [Time frame: Baseline to 8 weeks]
- University of Toronto Atrial fibrillation Severity Scale (AFSS) [Time frame: From baseline to 8 months]
- University of Toronto Atrial fibrillation Severity Scale (AFSS) [Time frame: From baseline to 1 year and 2 months]
- Behaviors following cardiac event questionnaire (BCEQ) [Time frame: From baseline to 8 weeks]
Eligibility criteria
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
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- Randomized
- Model
- Parallel assignment
- Masking
- Single blind
- Primary purpose
- Treatment
Study locations
Sweden · 1 center
- Karolinska University Hospital — Stockholm
Publications
- 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
Identifiers
NCT: NCT06298864 · ASC-RCT 2