Internet-delivered Cognitive Behavior Therapy Compared to Stress Management for Atrial Fibrillation

Study Overview
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Brief Summary
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The aim of this study 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), controlling for expectancy of improvement and attention from a caregiver, using an active control group (stress management). The study will include 260 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 controlling for expectancy of improvement and attention from a caregiver using an active control group receiving stress management treatment (SMT). Method: A randomized controlled trial. Participants are randomized to internet- delivered exposure-based CBT (N=130) or to SMT (N=130). Participants in both groups receive weekly therapist support through online written communication. The internet-delivered SMT-treatment includes life-style advice (e.g., exercise, sleep advice), relaxation and problem-solving skills to reduce stress. Both treatments lasts 10 weeks and are comparable regarding number of treatment modules, treatment burden and attention from the treating psychologist.

Official Title
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Internet-delivered Cognitive Behavior Therapy Compared to Stress Management for Atrial Fibrillation- a Randomized Controlled Trial With Active Control

Conditions
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Atrial Fibrillation, Arrythmia

Intervention / Treatment
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* Behavioral: Internet-deliviered exposure-based CBT
* Behavioral: Internet-delivered stress management treatment


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: 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); Scoring ≥ 20 on the Cardiac Anxiety Questionnaire at screening; Age 18-75 years; On optimal medical treatment; Able to read and write in Swedish. Exclusion Criteria: Heart failure with severe systolic dysfunction (ejection fraction ≤ 35%); Significant valvular disease; Planned ablation for AF or ablation within 3 months before assessment; Other severe medical illness; Any medical restriction to physical exercise; Severe psychiatric disorder, severe depression, or risk of suicide; Alcohol dependency; Previous participation in any AF-CBT study conducted by the research group.

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: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Internet-delivered exposure-focused CBT<br>Internet-delivered CBT over 10 weeks 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-deliviered exposure-based CBT<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>|
| Active Comparator: Internet-delivered stress management treatment<br>Stress management treatment for 10 weeks Participants randomized to The Stress Management Treatment will receive 10 weeks of stress managemen including relaxation technics, standard life style advice regarding physical activity, sleep and and standardized AF-information in line with current guidelines for AF. Therapist support is provided at least once weekly through the platform developed for the purpose. Therapists are trained CBT-psychologists. | Behavioral: Internet-delivered stress management treatment<br>* The intervention last for 10 weeks and include: Internet-SMT include life-style advice (e.g., exercise, sleep advice), relaxation and problem-solving skills to reduce stress. Patients are offered regular online contact with a psychologist with the same frequency and intensity as in the CBT arm.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Atrial Fibrillation Effect on Quality-of-Life modified for weekly assessment | The AFEQT is an atrial fibrillation-specific measure that taps into the QoL-domains: symptoms, daily activities, treatment concern, and treatment satisfaction. Total score ranges from 0 (severe symptoms and disability) to 100 (no symptoms and disability). | Change over 11 measurement points measured from baseline and weekly for 10 weeks during treatment [PRIMARY ENDPOINT] | 
| Atrial Fibrillation Effect on Quality-of-Life modified for weekly assessment | The AFEQT is an atrial fibrillation-specific measure that taps into the QoL-domains: symptoms, daily activities, treatment concern, and treatment satisfaction. Total score ranges from 0 (severe symptoms and disability) to 100 (no symptoms and disability). | From baseline to 9 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Cardiac Anxiety Questionnaire (CAQ) | Measure of cardiac anxiety, fear, avoidance and attention. The score ranges between 0 and 72, with a greater score indicating elevated cardiac anxiety. | From baseline to 10 weeks | 
| Cardiac Anxiety Questionnaire (CAQ) | Measure of cardiac anxiety, fear, avoidance and attention. The score ranges between 0 and 72, with a greater score indicating elevated cardiac anxiety. | From baseline to 9 months | 
| AF-avoidance behavior questionnaire | Form measuring AF-specific avoidance- and control behaviors, developed by the research group | From baseline to 10 weeks | 
| AF-avoidance behavior questionnaire | Form measuring AF-specific avoidance- and control behaviors, developed by the research group | From baseline to 9 months | 
| AF-avoidance behavior questionnaire modified for weekly assessment | 4 items from the AF-avoidance behavior questionnaire | Change over 11 measurement points measured from baseline and weekly for 10 weeks during treatment | 
| Short Form Health Survey (SF-12) | General quality of life, with a score ranging from 0 to 100. A higher score indicating a better quality of life | From baseline to 10 weeks | 
| Short Form Health Survey (SF-12) | General quality of life, with a score ranging from 0 to 100. A higher score indicating a better quality of life | From baseline to 9 months | 
| Atrial Fibrillation Severity Scale (4 items) | 4 items from the Atrial Fibrillation Severity Scale, measuring health care seeking | From baseline to 10 weeks | 
| Atrial Fibrillation Severity Scale (4 items) | 4 items from the Atrial Fibrillation Severity Scale, measuring health care seeking | From baseline to 9 months | 
| The Godin-Shepard Leisure-Time Physical Activity Questionnaire | Level of physical activity. 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. | From baseline to 10 weeks | 
| The Godin-Shepard Leisure-Time Physical Activity Questionnaire | Level of physical activity. 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. | From baseline to 9 months | 
| Body Sensation Questionnaire | Fear of bodily symptoms, score ranging from 0 to 72 . Higher scores indicate more fear of body sensations. | From baseline to 10 weeks | 
| Body Sensation Questionnaire | Fear of bodily symptoms, score ranging from 0 to 72 . Higher scores indicate more fear of body sensations. | From baseline to 9 months | 
| Patient Health Questionnaire-2 | Short form measuring depression, score ranging 0 to 6 with a higher score indicating higher level of depression. | From baseline to 10 weeks | 
| Patient Health Questionnaire-2 | Short form measuring depression, score ranging 0 to 6 ,with a higher score indicating higher level of depression. | From baseline to 9 months | 
| Perceived Stress Scale (4 items version) | Measures perceived stress, score ranging from 0-16, with a higher score indicating higher level of perceived stress | From baseline to 10 weeks | 
| Perceived Stress Scale (4 items version) | Measures perceived stress, score ranging from 0-16, with a higher score indicating higher level of perceived stress | From baseline to 9 months | 
| Generalized Anxiety Disorder-2 (GAD-2) | General anxiety, score ranging from 0-6, with a higher score indicating more anxiety and worry. | From baseline to 10 weeks | 
| Generalized Anxiety Disorder-2 | General anxiety, score ranging from 0-6, with a higher score indicating more anxiety and worry. | From baseline to 9 months | 
| Insomnia Severity Index (5 items) | Measure of insomnia, score ranging from 0-20, with a higher score indicating more severe insomnia | From baseline to 10 weeks | 
| Insomnia Severity Index (5 items) | Measure of insomnia, score ranging from 0-20, with a higher score indicating more severe insomnia | From Baseline to 9 months | 
| Perceived Competence Scale | Perception of AF-specific knowledge and competence, score ranging from 0- 50 with higher score indicating higher perceived competence | From baseline to 10 weeks | 
| Perceived Competence Scale | Perception of AF-specific knowledge and competence, score ranging from 0- 50 with higher score indicating higher perceived competence | From baseline to 9 months | 
| Client Satisfaction Questionnaire | Treatment satisfaction, score ranging from 0-24, with a higher score indicating higher satisfaction with treatment. | 10 weeks from baseline | 
| Adverse events | Potential adverse reactions to the treatment. Participants will be asked to report and rate the short- and long term discomfort of the adverse event on a scale from 0 ('did not affect me at all') and 3 ('affected me very negatively'). | 10 weeks from baseline | 
| Adverse events | Potential adverse reactions to the treatment. Participants will be asked to report and rate the short- and long term discomfort of the adverse event on a scale from 0 ('did not affect me at all') and 3 ('affected me very negatively'). | 9 months from baseline | 
| Symptoms Checklist Severity and Frequency Scale (SCL) | AF-related symptoms | From baseline to 10 weeks | 
| Symptoms Checklist Severity and Frequency Scale (SCL) | AF-related symptoms measured 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 | From baseline to 9 months | 
| AFFS/SCL-4 | 4 items derived from the Symptoms Checklist (SCL) and the Atrial Fibrillation Severity Scale (AFSS) measuring disabling cardiac symptoms not specified in AFEQT | Weekly from baseline to 10 weeks | 
| AFFS/SCL-4 | 4 items derived from the Symptoms Checklist (SCL) and the Atrial Fibrillation Severity Scale (AFSS) measuring disabling cardiac symptoms not specified in AFEQT | From baseline to 9 months |