Acute Coronary SyndromeACS-CBTNCT06298864
Internet-based Behavioral Intervention Following ACS
A study testing Internet-CBT and Internet-CL in people with Acute Coronary Syndrome and Online CBT Targeting Cardiac Anxiety, run by Karolinska Institutet at 1 site in Sweden.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Acute Coronary Syndrome, Online CBT Targeting Cardiac Anxiety
- What is being tested?
- Internet-CBT and Internet-CL
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 176 participants
- Where
- 1 siteSweden
- Study dates
- 7 Mar 2024to 31 Oct 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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)
Show all 9Show fewer
- 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 locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Sweden1 site, 1 recruiting
- Recruiting
Karolinska University Hospital
Stockholm, 11635
Josefin Särnholm, PhD
About this study
Official title: Digital Cognitive Behavioral Therapy for Cardiac Anxiety Following Acute Coronary Syndrome: a Randomized Controlled Trial Comparing CBT to a Digital Lifestyle Intervention
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.
Read the 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.
- Being tested
- Internet-CBT, Internet-CL
- Keywords
- Cardiac Anxiety, Acute Coronary Syndrome, ACS, Internet-CBT, CBT, Secondary prevention
- Medical subject headings
- Acute Coronary Syndrome
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Internet-CBTBehavioural
- 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-CLBehavioural
- 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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: Behavioral: Internet-CL |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Change over 9 measurement points measured from baseline and weekly for 8 weeks during treatment [PRIMARY ENDPOINT]
Secondary outcomes (39)
Cardiac anxiety questionnaire
Measure of cardiac anxiety, fear, avoidance and attention. The score ranges between 0 and 72, with a greater score indicating elevated cardiac anxiety.
Measured: From baseline to 8 months
Cardiac anxiety questionnaire
Measure of cardiac anxiety, fear, avoidance and attention. The score ranges between 0 and 72, with a greater score indicating elevated cardiac anxiety.
Measured: From baseline to 1 year and 2 months
HeartQoL Health-related Quality of Life Questionnaire modified for weekly assessment
The HeartQoL questionnaire, comprising 14 items, includes a Global scale of 14 items, further divided into Physical (10 items) and Emotional (4 items) subscales. Scores range from 0 to 3, with 3 indicating the highest level and 0 the lowest.
Measured: Change over 9 measurement points measured from baseline and weekly for 8 weeks during treatment
HeartQoL Health-related Quality of Life Questionnaire
The HeartQoL questionnaire, comprising 14 items, includes a Global scale of 14 items, further divided into Physical (10 items) and Emotional (4 items) subscales. Scores range from 0 to 3, with 3 indicating the highest level and 0 the lowest.
Measured: From baseline to 8 months
HeartQoL Health-related Quality of Life Questionnaire
The HeartQoL questionnaire, comprising 14 items, includes a Global scale of 14 items, further divided into Physical (10 items) and Emotional (4 items) subscales. Scores range from 0 to 3, with 3 indicating the highest level and 0 the lowest.
Measured: From baseline to 1 year and 2 months
Symptom checklist Severity and Frequency Scale (SCL, adapted to coronary artery disease) modified for weekly assessment
Cardiac-related symptoms in two sub scales A) frequency: score ranging from 0-48, with higher score indicating higher frequency of symptoms, B) severity of experienced symptom: score ranging from 0- 48, with a higher score indicating more severe symptoms
Measured: From baseline to 8 weeks
Symptom checklist Severity and Frequency Scale (SCL, adapted to coronary artery disease)
cardiac-related symptoms in two sub scales A) frequency: score ranging from 0-48, with higher score indicating higher frequency of symptoms, B) severity of experienced symptom: score ranging from 0- 48, with a higher score indicating more severe symptoms
Measured: From baseline to 8 months
Symptom checklist Severity and Frequency Scale (SCL, adapted to coronary artery disease)
Cardiac-related symptoms in two sub scales A) frequency: score ranging from 0-48, with higher score indicating higher frequency of symptoms, B) severity of experienced symptom: score ranging from 0- 48, with a higher score indicating more severe symptoms
Measured: From baseline to 1 year and 2 months
University of Toronto Atrial fibrillation Severity Scale (AFSS)
3 item on cardiac-specific healthcare consumption. Scores ranges 0-15 with a higher score indicating more cardiac-related healthcare consumption
Measured: Baseline to 8 weeks
University of Toronto Atrial fibrillation Severity Scale (AFSS)
3 item on cardiac-specific healthcare consumption. Scores ranges 0-15 with a higher score indicating more cardiac-related healthcare consumption
Measured: From baseline to 8 months
University of Toronto Atrial fibrillation Severity Scale (AFSS)
3 item on cardiac-specific healthcare consumption. Scores ranges 0-15 with a higher score indicating more cardiac-related healthcare consumption
Measured: From baseline to 1 year and 2 months
Behaviors following cardiac event questionnaire (BCEQ)
MI-related avoidance questionnaire behaviors developed by the research group
Measured: From baseline to 8 weeks
Behaviors following cardiac event questionnaire (BCEQ)
MI-related avoidance questionnaire behaviors developed by the research group
Measured: From baseline to 8 months
Behaviors following cardiac event questionnaire (BCEQ)
MI-related avoidance questionnaire behaviors developed by the research group
Measured: From baseline to 1 year and 2 months
DOSE Non-Adherence questionnaire
3 items from this two domain scale measuring medical adherence designed to assess missed doses and reasons for missed doses.
Measured: From baseline to 8 weeks
DOSE Non-Adherence questionnaire
3 items from this two domain scale measuring medical adherence designed to assess missed doses and reasons for missed doses.
Measured: From baseline to 8 months
DOSE Non-Adherence questionnaire
3 items from this two domain scale measuring medical adherence designed to assess missed doses and reasons for missed doses.
Measured: From baseline to 1 year and 2 months
Perceived stress scale 4-item
Stress reactivity. A greater score indicate more perceived stress.
Measured: Baseline to 8 weeks
Perceived stress scale 4-item
Stress reactivity. A greater score indicate more perceived stress.
Measured: Baseline to 8 months
Perceived stress scale 4-item
Stress reactivity. A greater score indicate more perceived stress.
Measured: Baseline to 1 year and 2 months
Short Fatigue questionnaire
4-item scale measuring fatigue.
Measured: From baseline to 8 weeks
Short Fatigue questionnaire
4-item scale measuring fatigue.
Measured: Baseline to 8 months
Short Fatigue questionnaire
4-item scale measuring fatigue.
Measured: Baseline to 1 year and 2 months
Patient Health Questionnaire-9
Measure of depression, score ranging 0 to 27 with a higher score indicating higher level of depression
Measured: From Baseline to 8 weeks
Patient Health Questionnaire-9
Measure of depression, score ranging 0 to 27 with a higher score indicating higher level of depression
Measured: From Baseline to 8 months
Patient Health Questionnaire-9
Measure of depression, score ranging 0 to 27 with a higher score indicating higher level of depression
Measured: From Baseline to 1 year and 2 months
Insomnia Severity Index
Measurement of the degree of sleep difficulties. The total score can range from 0 to 28 points. Higher scores indicate more severe sleep difficulties.
Measured: From Baseline to 8 weeks
Insomnia Severity Index
Measurement of the degree of sleep difficulties. The total score can range from 0 to 28 points. Higher scores indicate more severe sleep difficulties.
Measured: From Baseline to 8 months
Insomnia Severity Index
Measurement of the degree of sleep difficulties. The total score can range from 0 to 28 points. Higher scores indicate more severe sleep difficulties.
Measured: From Baseline to 1 year and 2 months
Perceived stress scale 4-item
Stress reactivity. A greater score indicate more perceived stress.
Measured: Change over 9 measurement points measured from baseline and weekly for 8 weeks during treatment
The Godin Leisure-time Exercise and International Physical Activity Questionnaire 1 item on inactivity
Level of physical activity and inactivity: On the Godin leisure-time excercise: The participant rate numbers of time per week that they engage in physical activity. The numb ers are the categorized in to low, moderate, and high levels of physical activity. And from International Physical Activity Questionnaire we will use 1 item on inactivity
Measured: Baseline to 8 weeks
The Godin Leisure-time Exercise and International Physical Activity Questionnaire 1 item on inactivity
Level of physical activity and inactivity: On the Godin leisure-time excercise: The participant rate numbers of time per week that they engage in physical activity. The numb ers are the categorized in to low, moderate, and high levels of physical activity. And from International Physical Activity Questionnaire we will use 1 item on inactivity
Measured: Baseline to 8 months
The Godin Leisure-time Exercise and International Physical Activity Questionnaire 1 item on inactivity
Level of physical activity and inactivity: On the Godin leisure-time excercise: The participant rate numbers of time per week that they engage in physical activity. The numb ers are the categorized in to low, moderate, and high levels of physical activity. And from International Physical Activity Questionnaire we will use 1 item on inactivity
Measured: Baseline to 1 year and 2 months
Lifestyle factors: The national Board of health and Welfare questionnaire
Questionnaire regarding diet (5 item), tobacco (2 item) and alcohol (3 item) diet (5 item), tobacco (2 item) and alcohol (3 item) and BMI.
Measured: Baseline to 8 weeks
Lifestyle factors: The national Board of health and Welfare questionnaire
Questionnaire regarding diet (5 item), tobacco (2 item) and alcohol (3 item) diet (5 item), tobacco (2 item) and alcohol (3 item) and BMI.
Measured: Baseline to 8 months
Lifestyle factors: The national Board of health and Welfare questionnaire
Questionnaire regarding diet (5 item), tobacco (2 item) and alcohol (3 item) diet (5 item), tobacco (2 item) and alcohol (3 item) and BMI.
Measured: Baseline to 1 year and 2 months
Aversive cognition to medication
: A 3-item subset of questions with regards to psychological distress associated with cardiac medication
Measured: Baseline to 8 weeks
Adversive cognition to medication
: A 3-item subset of questions with regards to psychological distress associated with cardiac medication
Measured: Baseline to 8 months
Adversive cognition to medication
: A 3-item subset of questions with regards to psychological distress associated with cardiac medication
Measured: Baseline to 1 year and 2 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Mar 2024
- Study start7 Mar 2024
- Primary completion31 Oct 2026 (estimated)
- Study completion31 Oct 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Acute Coronary SyndromeStudies of the same condition, open and under way.
- More trials run by Karolinska InstitutetThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 176 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Karolinska Institutet
- Sponsor type
- University, hospital or other
- Collaborators
- Karolinska University Hospital
- Responsible party
- Principal investigator, Josefin Särnholm, Karolinska Institutet
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06298864
- Sponsor's protocol ID
- ASC-RCT 2
- Acronym
- ACS-CBT
- Status last verified
- Sep 2025
- First submitted
- 26 Feb 2024
- Last updated
- 16 Sep 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: The individual participant data underlying the analyses in this study cannot be made publicly available due to Swedish and European Union data protection regulations. Requests for additional outcomes or estimates may be directed to the corresponding author and will be handled in accordance with legal expertise and the sponsor's current data governance guidelines
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.
PubMed 41151962
Study at a glance
From the registry record, last updated by the sponsor on 16 Sep 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Digital Cognitive Behavioral Therapy for Cardiac Anxiety Following Acute Coronary Syndrome: a Randomized Controlled Trial Comparing CBT to a Digital Lifestyle Intervention
- ClinicalTrials.gov ID
- NCT06298864
- Acronym / sponsor ID
- ACS-CBT / ASC-RCT 2
- Keywords
- Cardiac Anxiety, Acute Coronary Syndrome, ACS, Internet-CBT, CBT, Secondary prevention
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 176 participants (estimated)
- Lead sponsor
- Karolinska InstitutetUniversity, hospital or other
- Collaborators
- Karolinska University Hospital
- Study start
- 7 Mar 2024 (actual)
- Primary completion
- 31 Oct 2026 (estimated)
- Study completion
- 31 Oct 2027 (estimated)
- First posted
- 7 Mar 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Internet-based Cognitive Behavioral Therapy (Internet-CBT) | Experimental | Behavioral: Internet-CBTInternet-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-based Cardiac Lifestyle intervention (Internet-CL) | Active comparator | Behavioral: Internet-CLInternet-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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (9 listed)
- 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)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| 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. | Behavioural | Internet-based Cognitive Behavioral Therapy (Internet-CBT) |
| 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. | Behavioural | Internet-based Cardiac Lifestyle intervention (Internet-CL) |
Primary outcome
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]
Measure of cardiac anxiety, fear, avoidance and attention. The score ranges between 0 and 72, with a greater score indicating elevated cardiac anxiety.
39 secondary outcomes
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
Behaviors following cardiac event questionnaire (BCEQ)
Time frame: From baseline to 8 months
Behaviors following cardiac event questionnaire (BCEQ)
Time frame: From baseline to 1 year and 2 months
DOSE Non-Adherence questionnaire
Time frame: From baseline to 8 weeks
DOSE Non-Adherence questionnaire
Time frame: From baseline to 8 months
DOSE Non-Adherence questionnaire
Time frame: From baseline to 1 year and 2 months
Perceived stress scale 4-item
Time frame: Baseline to 8 weeks
Perceived stress scale 4-item
Time frame: Baseline to 8 months
Perceived stress scale 4-item
Time frame: Baseline to 1 year and 2 months
Short Fatigue questionnaire
Time frame: From baseline to 8 weeks
Short Fatigue questionnaire
Time frame: Baseline to 8 months
Short Fatigue questionnaire
Time frame: Baseline to 1 year and 2 months
Patient Health Questionnaire-9
Time frame: From Baseline to 8 weeks
Patient Health Questionnaire-9
Time frame: From Baseline to 8 months
Patient Health Questionnaire-9
Time frame: From Baseline to 1 year and 2 months
Insomnia Severity Index
Time frame: From Baseline to 8 weeks
Insomnia Severity Index
Time frame: From Baseline to 8 months
Insomnia Severity Index
Time frame: From Baseline to 1 year and 2 months
Perceived stress scale 4-item
Time frame: Change over 9 measurement points measured from baseline and weekly for 8 weeks during treatment
The Godin Leisure-time Exercise and International Physical Activity Questionnaire 1 item on inactivity
Time frame: Baseline to 8 weeks
The Godin Leisure-time Exercise and International Physical Activity Questionnaire 1 item on inactivity
Time frame: Baseline to 8 months
The Godin Leisure-time Exercise and International Physical Activity Questionnaire 1 item on inactivity
Time frame: Baseline to 1 year and 2 months
Lifestyle factors: The national Board of health and Welfare questionnaire
Time frame: Baseline to 8 weeks
Lifestyle factors: The national Board of health and Welfare questionnaire
Time frame: Baseline to 8 months
Lifestyle factors: The national Board of health and Welfare questionnaire
Time frame: Baseline to 1 year and 2 months
Aversive cognition to medication
Time frame: Baseline to 8 weeks
Adversive cognition to medication
Time frame: Baseline to 8 months
Adversive cognition to medication
Time frame: Baseline to 1 year and 2 months
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Sep 2025.
- Derived from this study: PubMed 41151962Johnsson 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.
- Individual participant dataSharing planned: No. The individual participant data underlying the analyses in this study cannot be made publicly available due to Swedish and European Union data protection regulations. Requests for additional outcomes or estimates may be directed to the corresponding author and will be handled in accordance with legal expertise and the sponsor's current data governance guidelines
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Internet-CBT and Internet-CL in people with Acute Coronary Syndrome and Online CBT Targeting Cardiac Anxiety, run by Karolinska Institutet at 1 site in Sweden.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 16 Sep 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Sweden. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Josefin Särnholm, Lic psychologist, PhD (+ 46 852483258, josefin.sarnholm@ki.se), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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]). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06298864, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 16 Sep 2025.