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.
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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
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.
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.
Karolinska universitetssjukhuset Solna
Solna, Sweden
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).
Time frame: 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).
Time frame: From baseline to 9 months
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.
Time frame: 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.
Time frame: From baseline to 9 months
AF-avoidance behavior questionnaire
Form measuring AF-specific avoidance- and control behaviors, developed by the research group
Time frame: From baseline to 10 weeks
AF-avoidance behavior questionnaire
Form measuring AF-specific avoidance- and control behaviors, developed by the research group
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Enrollment
206
Time frame: From baseline to 9 months
AF-avoidance behavior questionnaire modified for weekly assessment
4 items from the AF-avoidance behavior questionnaire
Time frame: 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
Time frame: 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
Time frame: From baseline to 9 months
Atrial Fibrillation Severity Scale (4 items)
4 items from the Atrial Fibrillation Severity Scale, measuring health care seeking
Time frame: From baseline to 10 weeks
Atrial Fibrillation Severity Scale (4 items)
4 items from the Atrial Fibrillation Severity Scale, measuring health care seeking
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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
Time frame: 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
Time frame: 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.
Time frame: 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.
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: From baseline to 9 months
Client Satisfaction Questionnaire
Treatment satisfaction, score ranging from 0-24, with a higher score indicating higher satisfaction with treatment.
Time frame: 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').
Time frame: 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').
Time frame: 9 months from baseline
Symptoms Checklist Severity and Frequency Scale (SCL)
AF-related symptoms
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: From baseline to 9 months