Internet-based 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 CBT, based on behavioral activation and exposure principles, improves wellbeing and QoL in symptomatic AF patients.The study will include 30 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. Method: Pilot study with a pre-post-design and no control group. The internet-delivered CBT-program will last for 10 weeks and include weekly therapist support, consisting of online messages and telephone calls.

Official Title
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Internet-based Cognitive Behavior Therapy for Atrial Fibrillation

Conditions
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Atrial Fibrillation, Arrhythmia

Intervention / Treatment
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* Behavioral: Internet-based cognitive behavior therapy


Participation Criteria
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Eligibility Criteria
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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) [31]; B) Age 18-75 years; C) Able to read and write in Swedish. Exclusion Criteria: C) Heart failure with severe systolic dysfunction (ejection fraction ≤ 35%); D) Significant valvular disease; E) Other severe medical illness; F) Severe depression or risk of suicide; G) 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
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Internet-based cognitive behavior therapy<br>10 sessions of ICBT during 10 weeks. | Behavioral: Internet-based cognitive behavior therapy<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 fruitlessly aim to prevent triggering of AF episodes or 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.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in 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 | 
| Change in 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. | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| WHODAS 2.0 (12-item version) • | Change in general quality of life | From baseline to 12 weeks. | 
| WHODAS 2.0 (12-item version) • | Change in general quality of life: | From baseline to 9 months. | 
| Symptom checklist (SCL) | Change in AF related symptoms: | From baseline to 12 weeks. | 
| Symptom checklist (SCL) | Change in AF related symptoms: | From baseline to 9 months. | 
| Atrial Fibrillation Severity Scale | Change in symptomatic burden | From baseline to 12 weeks. | 
| Atrial Fibrillation Severity Scale | Change in symptomatic burden | From baseline to 9 months. | 
| Cardiac Anxiety Questionnaire | Change in symptom preoccupation: | From baseline to 12 weeks. | 
| Cardiac Anxiety Questionnaire | Change in symptom preoccupation | From baseline to 9 months. | 
| GAD-7 | Change in anxiety | From baseline to 12 weeks. | 
| GAD-7 | Change in anxiety | From baseline to 9 months. | 
| PHQ-9 | Change in depression: | From baseline to 12 weeks. | 
| PHQ-9 | Change in depression | From baseline to 9 months. | 
| Perceived stress scale | Change in stress reactivity | From baseline to 12 weeks. | 
| Perceived stress scale | Change in stress reactivity | From baseline to 9 months. | 
| Change in healthcare consumption and work loss: TIC-P | The Trimbos and Institute of Medical Technology Assessment Cost Questionnaire for Psychiatry assesses societal cost during the last month. These costs include the participant's health care consumption (direct medical costs), time spent in other health promoting activities (direct non-medical costs), and sick leave, unemployment, and reduced work capacity at work and in the domestic realm (indirect non-medical costs). | From baseline to 12 weeks. | 
| Change in healthcare consumption and work loss: TIC-P | The Trimbos and Institute of Medical Technology Assessment Cost Questionnaire for Psychiatry assesses societal cost during the last month. These costs include the participant's health care consumption (direct medical costs), time spent in other health promoting activities (direct non-medical costs), and sick leave, unemployment, and reduced work capacity at work and in the domestic realm (indirect non-medical costs). | From baseline to 9 months. | 
| Change in symtomatic burden: Holter ECG. | The patient will undergo a 24 h 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. | 
| Change in symptomatic burden: Holter ECG. | The patient will undergo a 24 h ECG assessment in order to measure objectively symptomatic burden (number and duration of symptomatic AF episodes and symptomatic non-AF episodes) | From baseline to 9 months. |