Atrial FibrillationNCT03378349
Internet-delivered Cognitive Behavior Therapy for Atrial Fibrillation
A study testing Internet-delivered cognitive behavior therapy and Treatment as usual in people with Atrial Fibrillation and Arrhythmia, run by Karolinska Institutet at 1 site in Sweden.
Trial summary
The aim is to evaluate if internet- delivered cognitive behavior therapy (CBT), based on exposure principles and behavioral activation, improves QoL and symptom burden in patients with symptomatic atrial fibrillation (AF) compared to treatment as usual. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Atrial Fibrillation, Arrhythmia
- What is being tested?
- Internet-delivered cognitive behavior therapy and Treatment as usual
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 126 participants
- Where
- 1 siteSweden
- Study dates
- 8 Jan 2018to 20 Sep 2020
- Phase
- Interventional
- Are there results?
- None posted in the registry
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 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Inclusion criteria: A) Paroxysmal AF ≥ once per month that causes moderate to severe symptoms and leads to significant distress or interferes with daily life (i.e. EHRA class ≥ IIb) ; B) Age 18-75 years; C) On optimal medical treatment; D). Able to read and write in Swedish.
Who cannot join
- (E) heart failure with severe systolic dysfunction (ejection fraction ≤ 35%); (F) significant valvular disease; (G) planned ablation for AF or ablation within 3 months before assessment; (H) other severe medical illness; (I) any medical restriction to physical exercise; (J) severe psychiatric disorder, severe depression, or risk of suicide; (K) alcohol dependency.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Internet-delivered Cognitive Behavior Therapy for Atrial Fibrillation - a Randomized Controlled Trial
The aim is to evaluate if internet- delivered cognitive behavior therapy (CBT), based on exposure principles and behavioral activation, improves QoL and symptom burden in patients with symptomatic atrial fibrillation (AF) compared to treatment as usual. The study will include 120 patients with symptomatic AF despite optimal medical treatment in accordance with current guidelines.
Read the detailed description
Atrial fibrillation (AF) is the most common cardiac arrhythmia (irregular heartbeat) affecting 3% of the population. AF is associated with poor quality of life (QoL) and large costs for society. In a considerable proportion of patients, AF symptoms (e.g., palpitations, fatigue, and chest pain) are not alleviated by current medical or interventional treatments. Psychological factors can worsen AF symptoms, and anxiety and depression are common among AF patients. Symptom preoccupation and avoidance of social and physical activities are likely to play important roles in the development of anxiety, depression, disability and healthcare utilization.
The aim is to evaluate if CBT, based on behavioral activation and exposure principles, improves wellbeing and QoL in symptomatic AF patients more than a wait list offered treatment as usual.
Method: A randomized controlled trial. Participants are randomized to internet-delivered CBT for 10 weeks (N=60) or to treatment as usual (N=60). The internet-delivered CBT-program will last for 10 weeks and include weekly therapist support, consisting of online messages and telephone calls. Patients on the treatment as usual wait list will be provided standardized written information about basic self-management in AF. The treatment as usual wait list will be crossed over to treatment 3 months after the treatment group has completed treatment.
- Conditions
- Atrial Fibrillation, Arrhythmia
- Being tested
- Internet-delivered cognitive behavior therapy, Treatment as usual
- Medical subject headings
- Atrial Fibrillation, Arrhythmias, Cardiac
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Internet-delivered cognitive behavior therapyBehavioural
The intervention lasts for 10 weeks and include: Education, Interoceptive exposure, exposure in-vivo, combining in-vivo exposure with interoceptive exposure, behavioral activation and relapse prevention. Include the guidance of a minimum weekly contact with a CBT psychologist.
Treatment as usualBehavioural
Consist of standardized AF information that emphasizes that an active physical and social lifestyle is necessary to maintain good health, without the guidance of a psychologist or any CBT interventions.
| Study group | Role | What they receive |
|---|---|---|
| Internet-delivered CBT over 10 weeks | Experimental | The CBT treatment lasts for 10 weeks and includes the following: Education on the role of anxiety on cardiac function and the effects of symptom preoccupation and avoidance QoL and depression in AF, creating a vicious cycle; exposure to physical sensations that are similar to AF symptoms (e.g.,palpitations due to physical activity or stress) to reduce fear of these symptoms; exposure to situations or activities previously avoided and abolishment of behaviors that aim to control symptoms; and behavioral activation aiming to increase social and physical activity and reduce depressive symptoms. Therapist support is provided at least once weekly through the platform developed for the purpose. Therapists are trained CBT-psychologists. Receives: Behavioral: Internet-delivered cognitive behavior therapy |
| Treatment as usual wait list | Placebo comparator | Patients randomized to the treatment as usual wait list arm will receive standardized AF information that emphasizes that an active physical and social lifestyle is necessary to maintain good health. Thus, the treatment as usual arm will control for the provision of basic patient information, but without the guidance of a psychologist or any CBT interventions. Receives: Behavioral: Treatment as usual |
What is being measured
The primary outcome is the main question the study is designed to answer.
The Atrial Fibrillation Quality of Life (AFEQT)
The AFEQT is an atrial fibrillation-specific measure that taps into the QoL-domains: symptoms, daily activities, treatment concern, and treatment satisfaction.
Measured: From baseline to 6 months PRIMARY ENDPOINT
The Atrial Fibrillation Quality of Life (AFEQT)
The AFEQT is an atrial fibrillation-specific measure that taps into the QoL-domains: symptoms, daily activities, treatment concern, and treatment satisfaction.
Measured: From baseline to 12 weeks
The Atrial Fibrillation Quality of Life (AFEQT)
The AFEQT is an atrial fibrillation-specific measure that taps into the QoL-domains: symptoms, daily activities, treatment concern, and treatment satisfaction.
Measured: From baseline to 9 months
The Atrial Fibrillation Quality of Life (AFEQT)
The AFEQT is an atrial fibrillation-specific measure that taps into the QoL-domains: symptoms, daily activities, treatment concern, and treatment satisfaction.
Measured: From baseline to 15 months
Secondary outcomes (21)
Electrocardiography (ECG) measurement
Change in symptomatic burden. The patient will undergo 5 days ECG assessment in order to measure objectively symptomatic burden (number and duration of symptomatic AF episodes and symptomatic "non-AF episodes")
Measured: From baseline to 12 weeks
ECG measurement
Change in symptomatic burden. The patient will undergo 5 days ECG assessment in order to measure objectively symptomatic burden (number and duration of symptomatic AF episodes and symptomatic "non-AF episodes")
Measured: From baseline to 6 months
ECG measurement
Change in symptomatic burden. The patient will undergo 5 days ECG assessment in order to measure objectively symptomatic burden (number and duration of symptomatic AF episodes and symptomatic "non-AF episodes")
Measured: From baseline to 15 months
Cardiac Anxiety Questionary (CAQ)
Symptom preoccupation
Measured: From baseline to 12 weeks
Cardiac Anxiety Questionary (CAQ)
Symptom preoccupation
Measured: From baseline to 6 months
Cardiac Anxiety Questionary (CAQ)
Symptom preoccupation
Measured: From baseline to 9 months
Cardiac Anxiety Questionary (CAQ)
Symptom preoccupation
Measured: From baseline to 15 months
the World Health Organization Disability Assessment Schedule (WHODAS 2.0, 12- item version)
General quality of life
Measured: From baseline to 12 weeks
WHODAS 2.0 (12-item version)
General quality of life
Measured: From baseline to 6 months
WHODAS 2.0 (12-item version)
General quality of life
Measured: From baseline to 15 months
Symptom checklist Severity and Frequency Scale (SCL)
AF related symptoms
Measured: From baseline to 12 weeks
Symptom checklist Severity and Frequency Scale (SCL)
AF related symptoms
Measured: From baseline to 6 months
Symptom checklist Severity and Frequency Scale (SCL)
AF related symptoms
Measured: From baseline to 15 months
Atrial Fibrillation Severity Scale
Symptomatic burden
Measured: From baseline to 12 weeks
Atrial Fibrillation Severity Scale
Symptomatic burden
Measured: From baseline to 6 months
Atrial Fibrillation Severity Scale
Symptomatic burden
Measured: From baseline to 15 months
Patient Health Questionnaire (PHQ-9)
Depression
Measured: From baseline to 12 weeks
PHQ-9
Depression
Measured: From baseline to 6 months
PHQ-9
Depression
Measured: From baseline to 15 months
Client satisfaction Questionnaire
Treatment satisfaction
Measured: From baseline to 12 weeks
Adverse events
Potential adverse reactions to the treatment
Measured: From baseline to 12 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Dec 2017
- Study start8 Jan 2018
- Primary completion20 Dec 2019
- Study completion20 Sep 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Atrial FibrillationStudies 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
- Crossover
- Masking
- None (open label)
- Enrolment
- 126 participants (actual)
Sponsor and investigators
- Lead sponsor
- Karolinska Institutet
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Brjann Ljotsson, Karolinska Institutet
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03378349
- Sponsor's protocol ID
- AF RCT 1
- Status last verified
- Sep 2020
- First submitted
- 11 Dec 2017
- Last updated
- 23 Sep 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Sarnholm J, Axelsson E, Skuladottir H, Bonnert M, Bragesjo M, Ruck C, Pedersen SS, Braunschweig F, Ljotsson B. The role of cardiac-related fear, hypervigilance, and avoidance behavior in exposure-based cognitive behavioral therapy for atrial fibrillation: A mediation analysis based on a randomized controlled trial. J Consult Clin Psychol. 2025 Aug;93(8):527-539. doi: 10.1037/ccp0000961.
PubMed 40811118Sarnholm J, Skuladottir H, Ruck C, Axelsson E, Bonnert M, Bragesjo M, Venkateshvaran A, Olafsdottir E, Pedersen SS, Ljotsson B, Braunschweig F. Cognitive Behavioral Therapy Improves Quality of Life in Patients With Symptomatic Paroxysmal Atrial Fibrillation. J Am Coll Cardiol. 2023 Jul 4;82(1):46-56. doi: 10.1016/j.jacc.2023.04.044.
PubMed 37380303
Study at a glance
From the registry record, last updated by the sponsor on 23 Sep 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Internet-delivered Cognitive Behavior Therapy for Atrial Fibrillation - a Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT03378349
- Acronym / sponsor ID
- AF RCT 1
- Conditions
- Atrial Fibrillation, Arrhythmia
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 126 participants (actual)
- Lead sponsor
- Karolinska InstitutetUniversity, hospital or other
- Study start
- 8 Jan 2018 (actual)
- Primary completion
- 20 Dec 2019 (actual)
- Study completion
- 20 Sep 2020 (actual)
- First posted
- 19 Dec 2017 (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 is to evaluate if internet- delivered cognitive behavior therapy (CBT), based on exposure principles and behavioral activation, improves QoL and symptom burden in patients with symptomatic atrial fibrillation (AF) compared to treatment as usual. The study will include 120 patients with symptomatic AF despite optimal medical treatment in accordance with current guidelines.
Detailed description
Atrial fibrillation (AF) is the most common cardiac arrhythmia (irregular heartbeat) affecting 3% of the population. AF is associated with poor quality of life (QoL) and large costs for society. In a considerable proportion of patients, AF symptoms (e.g., palpitations, fatigue, and chest pain) are not alleviated by current medical or interventional treatments. Psychological factors can worsen AF symptoms, and anxiety and depression are common among AF patients. Symptom preoccupation and avoidance of social and physical activities are likely to play important roles in the development of anxiety, depression, disability and healthcare utilization.
The aim is to evaluate if CBT, based on behavioral activation and exposure principles, improves wellbeing and QoL in symptomatic AF patients more than a wait list offered treatment as usual.
Method: A randomized controlled trial. Participants are randomized to internet-delivered CBT for 10 weeks (N=60) or to treatment as usual (N=60). The internet-delivered CBT-program will last for 10 weeks and include weekly therapist support, consisting of online messages and telephone calls. Patients on the treatment as usual wait list will be provided standardized written information about basic self-management in AF. The treatment as usual wait list will be crossed over to treatment 3 months after the treatment group has completed treatment.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Internet-delivered CBT over 10 weeks | Experimental | Behavioral: Internet-delivered cognitive behavior therapyThe CBT treatment lasts for 10 weeks and includes the following: Education on the role of anxiety on cardiac function and the effects of symptom preoccupation and avoidance QoL and depression in AF, creating a vicious cycle; exposure to physical sensations that are similar to AF symptoms (e.g.,palpitations due to physical activity or stress) to reduce fear of these symptoms; exposure to situations or activities previously avoided and abolishment of behaviors that aim to control symptoms; and behavioral activation aiming to increase social and physical activity and reduce depressive symptoms. Therapist support is provided at least once weekly through the platform developed for the purpose. Therapists are trained CBT-psychologists. |
| Treatment as usual wait list | Placebo comparator | Behavioral: Treatment as usualPatients randomized to the treatment as usual wait list arm will receive standardized AF information that emphasizes that an active physical and social lifestyle is necessary to maintain good health. Thus, the treatment as usual arm will control for the provision of basic patient information, but without the guidance of a psychologist or any CBT interventions. |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Inclusion criteria: A) Paroxysmal AF ≥ once per month that causes moderate to severe symptoms and leads to significant distress or interferes with daily life (i.e. EHRA class ≥ IIb) ; B) Age 18-75 years; C) On optimal medical treatment; D). Able to read and write in Swedish.
Key exclusion criteria (1 listed)
- (E) heart failure with severe systolic dysfunction (ejection fraction ≤ 35%); (F) significant valvular disease; (G) planned ablation for AF or ablation within 3 months before assessment; (H) other severe medical illness; (I) any medical restriction to physical exercise; (J) severe psychiatric disorder, severe depression, or risk of suicide; (K) alcohol dependency.
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-delivered cognitive behavior therapyThe intervention lasts for 10 weeks and include: Education, Interoceptive exposure, exposure in-vivo, combining in-vivo exposure with interoceptive exposure, behavioral activation and relapse prevention. Include the guidance of a minimum weekly contact with a CBT psychologist. | Behavioural | Internet-delivered CBT over 10 weeks |
| Treatment as usualConsist of standardized AF information that emphasizes that an active physical and social lifestyle is necessary to maintain good health, without the guidance of a psychologist or any CBT interventions. | Behavioural | Treatment as usual wait list |
Primary outcome
The Atrial Fibrillation Quality of Life (AFEQT)
Time frame: From baseline to 6 months PRIMARY ENDPOINT
The AFEQT is an atrial fibrillation-specific measure that taps into the QoL-domains: symptoms, daily activities, treatment concern, and treatment satisfaction.
The Atrial Fibrillation Quality of Life (AFEQT)
Time frame: From baseline to 12 weeks
The AFEQT is an atrial fibrillation-specific measure that taps into the QoL-domains: symptoms, daily activities, treatment concern, and treatment satisfaction.
The Atrial Fibrillation Quality of Life (AFEQT)
Time frame: From baseline to 9 months
The AFEQT is an atrial fibrillation-specific measure that taps into the QoL-domains: symptoms, daily activities, treatment concern, and treatment satisfaction.
The Atrial Fibrillation Quality of Life (AFEQT)
Time frame: From baseline to 15 months
The AFEQT is an atrial fibrillation-specific measure that taps into the QoL-domains: symptoms, daily activities, treatment concern, and treatment satisfaction.
21 secondary outcomes
Electrocardiography (ECG) measurement
Time frame: From baseline to 12 weeks
ECG measurement
Time frame: From baseline to 6 months
ECG measurement
Time frame: From baseline to 15 months
Cardiac Anxiety Questionary (CAQ)
Time frame: From baseline to 12 weeks
Cardiac Anxiety Questionary (CAQ)
Time frame: From baseline to 6 months
Cardiac Anxiety Questionary (CAQ)
Time frame: From baseline to 9 months
Cardiac Anxiety Questionary (CAQ)
Time frame: From baseline to 15 months
the World Health Organization Disability Assessment Schedule (WHODAS 2.0, 12- item version)
Time frame: From baseline to 12 weeks
WHODAS 2.0 (12-item version)
Time frame: From baseline to 6 months
WHODAS 2.0 (12-item version)
Time frame: From baseline to 15 months
Symptom checklist Severity and Frequency Scale (SCL)
Time frame: From baseline to 12 weeks
Symptom checklist Severity and Frequency Scale (SCL)
Time frame: From baseline to 6 months
Symptom checklist Severity and Frequency Scale (SCL)
Time frame: From baseline to 15 months
Atrial Fibrillation Severity Scale
Time frame: From baseline to 12 weeks
Atrial Fibrillation Severity Scale
Time frame: From baseline to 6 months
Atrial Fibrillation Severity Scale
Time frame: From baseline to 15 months
Patient Health Questionnaire (PHQ-9)
Time frame: From baseline to 12 weeks
PHQ-9
Time frame: From baseline to 6 months
PHQ-9
Time frame: From baseline to 15 months
Client satisfaction Questionnaire
Time frame: From baseline to 12 weeks
Adverse events
Time frame: From baseline to 12 weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Sep 2020.
- Derived from this study: PubMed 40811118Sarnholm J, Axelsson E, Skuladottir H, Bonnert M, Bragesjo M, Ruck C, Pedersen SS, Braunschweig F, Ljotsson B. The role of cardiac-related fear, hypervigilance, and avoidance behavior in exposure-based cognitive behavioral therapy for atrial fibrillation: A mediation analysis based on a randomized controlled trial. J Consult Clin Psychol. 2025 Aug;93(8):527-539. doi: 10.1037/ccp0000961.
- Derived from this study: PubMed 37380303Sarnholm J, Skuladottir H, Ruck C, Axelsson E, Bonnert M, Bragesjo M, Venkateshvaran A, Olafsdottir E, Pedersen SS, Ljotsson B, Braunschweig F. Cognitive Behavioral Therapy Improves Quality of Life in Patients With Symptomatic Paroxysmal Atrial Fibrillation. J Am Coll Cardiol. 2023 Jul 4;82(1):46-56. doi: 10.1016/j.jacc.2023.04.044.
- Individual participant dataSharing planned: No
Related trials for Atrial Fibrillation
Recruiting
Structured Treatment and Resource Efficiency Assessment With Lean Six Sigma Integration for Pulmonary Vein Isolation
Atrial Fibrillation (AF)
Active, not recruiting
VOLT CE Mark Study
Atrial Arrhythmia, Atrial Fibrillation
RecruitingObservational study
AI-Based Cardiac Analysis Using 12-Lead and 1-Lead ECG
Heart Failure, Atrial Fibrillation (AF)
RecruitingObservational study
Observational Study of Cardiac Arrhythmias During Treatment With BTK Inhibitors or Venetoclax
Chronic Lymphocytic Leukemia (CLL), Waldenstr(SqrRoot)(Delta)m s Macroglobulinemia
Active, not recruiting
ARIADNE Clinical Trial
Persistent Atrial Fibrillation
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. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
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-delivered cognitive behavior therapy and Treatment as usual in people with Atrial Fibrillation and Arrhythmia, 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 1 inclusion and 1 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: finished, as of the sponsor's last update on 23 Sep 2020. 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. Some participants in this study may receive a placebo. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The Atrial Fibrillation Quality of Life (AFEQT) (time frame: From baseline to 6 months PRIMARY ENDPOINT). The study lists 4 primary outcomes in all. 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 NCT03378349, which also lists 2 linked publications.
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 23 Sep 2020.