Internet-delivered Cognitive Behavior Therapy for Atrial Fibrillation

Study Overview
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Brief Summary
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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
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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.

Official Title
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Internet-delivered Cognitive Behavior Therapy for Atrial Fibrillation - a Randomized Controlled Trial

Conditions
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Atrial Fibrillation, Arrhythmia

Intervention / Treatment
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* Behavioral: Internet-delivered cognitive behavior therapy
* Behavioral: Treatment as usual


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: 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. Exclusion Criteria: (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.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 75 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Internet-delivered CBT over 10 weeks<br>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. | Behavioral: Internet-delivered cognitive behavior therapy<br>* 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.<br>|
| Placebo Comparator: Treatment as usual wait list<br>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. | Behavioral: Treatment as usual<br>* 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.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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. | 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. | 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. | 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. | From baseline to 15 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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) | 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) | 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) | From baseline to 15 months | 
| Cardiac Anxiety Questionary (CAQ) | Symptom preoccupation | From baseline to 12 weeks | 
| Cardiac Anxiety Questionary (CAQ) | Symptom preoccupation | From baseline to 6 months | 
| Cardiac Anxiety Questionary (CAQ) | Symptom preoccupation | From baseline to 9 months | 
| Cardiac Anxiety Questionary (CAQ) | Symptom preoccupation | From baseline to 15 months | 
| the World Health Organization Disability Assessment Schedule (WHODAS 2.0, 12- item version) | General quality of life | From baseline to 12 weeks | 
| WHODAS 2.0 (12-item version) | General quality of life | From baseline to 6 months | 
| WHODAS 2.0 (12-item version) | General quality of life | From baseline to 15 months | 
| Symptom checklist Severity and Frequency Scale (SCL) | AF related symptoms | From baseline to 12 weeks | 
| Symptom checklist Severity and Frequency Scale (SCL) | AF related symptoms | From baseline to 6 months | 
| Symptom checklist Severity and Frequency Scale (SCL) | AF related symptoms | From baseline to 15 months | 
| Atrial Fibrillation Severity Scale | Symptomatic burden | From baseline to 12 weeks | 
| Atrial Fibrillation Severity Scale | Symptomatic burden | From baseline to 6 months | 
| Atrial Fibrillation Severity Scale | Symptomatic burden | From baseline to 15 months | 
| Patient Health Questionnaire (PHQ-9) | Depression | From baseline to 12 weeks | 
| PHQ-9 | Depression | From baseline to 6 months | 
| PHQ-9 | Depression | From baseline to 15 months | 
| Client satisfaction Questionnaire | Treatment satisfaction | From baseline to 12 weeks | 
| Adverse events | Potential adverse reactions to the treatment | From baseline to 12 weeks |