Arrythmia, Atrial Fibrillation
Conditions
Brief summary
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
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.
Interventions
BEHAVIORALInternet-deliviered exposure-based CBT
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.
BEHAVIORALInternet-delivered stress management treatment
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.
Sponsors
Karolinska University Hospital
Karolinska Institutet
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Subject)
Eligibility
Sex/Gender
ALL
Age
18 Years to 75 Years
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Atrial Fibrillation Effect on Quality-of-Life modified for weekly assessment | Change over 11 measurement points measured from baseline and weekly for 10 weeks during treatment [PRIMARY ENDPOINT] | 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). |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Body Sensation Questionnaire | From baseline to 10 weeks | Fear of bodily symptoms, score ranging from 0 to 72 . Higher scores indicate more fear of body sensations. |
| Perceived Competence Scale | From baseline to 10 weeks | Perception of AF-specific knowledge and competence, score ranging from 0- 50 with higher score indicating higher perceived competence |
| Client Satisfaction Questionnaire | 10 weeks from baseline | Treatment satisfaction, score ranging from 0-24, with a higher score indicating higher satisfaction with treatment. |
| Adverse events | 10 weeks from baseline | 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'). |
| Symptoms Checklist Severity and Frequency Scale (SCL) | From baseline to 10 weeks | AF-related symptoms |
| AFFS/SCL-4 | Weekly from baseline to 10 weeks | 4 items derived from the Symptoms Checklist (SCL) and the Atrial Fibrillation Severity Scale (AFSS) measuring disabling cardiac symptoms not specified in AFEQT |
| Cardiac Anxiety Questionnaire (CAQ) | From baseline to 10 weeks | Measure of cardiac anxiety, fear, avoidance and attention. The score ranges between 0 and 72, with a greater score indicating elevated cardiac anxiety. |
| AF-avoidance behavior questionnaire | From baseline to 10 weeks | Form measuring AF-specific avoidance- and control behaviors, developed by the research group |
| AF-avoidance behavior questionnaire modified for weekly assessment | Change over 11 measurement points measured from baseline and weekly for 10 weeks during treatment | 4 items from the AF-avoidance behavior questionnaire |
| Short Form Health Survey (SF-12) | From baseline to 10 weeks | General quality of life, with a score ranging from 0 to 100. A higher score indicating a better quality of life |
| Atrial Fibrillation Severity Scale (4 items) | From baseline to 10 weeks | 4 items from the Atrial Fibrillation Severity Scale, measuring health care seeking |
| The Godin-Shepard Leisure-Time Physical Activity Questionnaire | From baseline to 10 weeks | 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. |
| Patient Health Questionnaire-2 | From baseline to 10 weeks | Short form measuring depression, score ranging 0 to 6 with a higher score indicating higher level of depression. |
| Perceived Stress Scale (4 items version) | From baseline to 10 weeks | Measures perceived stress, score ranging from 0-16, with a higher score indicating higher level of perceived stress |
| Generalized Anxiety Disorder-2 (GAD-2) | From baseline to 10 weeks | General anxiety, score ranging from 0-6, with a higher score indicating more anxiety and worry. |
| Generalized Anxiety Disorder-2 | From baseline to 9 months | General anxiety, score ranging from 0-6, with a higher score indicating more anxiety and worry. |
| Insomnia Severity Index (5 items) | From baseline to 10 weeks | Measure of insomnia, score ranging from 0-20, with a higher score indicating more severe insomnia |
Other
| Measure | Time frame | Description |
|---|---|---|
| Treatment Credibility Scale | 2-4 weeks from baseline | Measures treatment credibility |
| Working Alliance Inventory | 2-4 weeks from baseline | Measures therapeutic alliance with the psychologist |
| Changes in medication | 10 weeks from baseline | Participants are asked if they have made any changes in medication |
| Psychosocial stressors and changes in physical health | 10 weeks from baseline | Participants are asked about their self-perceived health and if they have experienced any stressful event that they believe have affected their health (e.g severe disease, death of close relative, divorce) |
| Background data | Baseline | Demographics, list of medications, co-morbidity, smoking history and alcohol consumption |
Countries
Sweden
Outcome results
None listed