Study Results
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Basic Information
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RECRUITING
NA
176 participants
INTERVENTIONAL
2024-03-07
2027-10-31
Brief Summary
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Detailed Description
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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.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
SINGLE
Study Groups
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Internet-based Cognitive Behavioral Therapy (Internet-CBT)
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.
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) 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 Cardiac Lifestyle intervention (Internet-CL)
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.
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.
Interventions
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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) 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-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.
Eligibility Criteria
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Inclusion Criteria
* 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
* 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
18 Years
ALL
No
Sponsors
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Karolinska University Hospital
OTHER
Karolinska Institutet
OTHER
Responsible Party
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Josefin Särnholm
PhD, Lic. Psychologist
Locations
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Karolinska University Hospital
Stockholm, , Sweden
Countries
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Central Contacts
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Facility Contacts
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Josefin Särnholm, PhD
Role: primary
References
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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.
Other Identifiers
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ASC-RCT 2
Identifier Type: -
Identifier Source: org_study_id
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