Arrhythmia, Atrial Fibrillation
Conditions
Brief summary
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
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.
Interventions
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.
BEHAVIORALTreatment as usual
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.
Sponsors
Karolinska Institutet
Study design
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 75 Years
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| The Atrial Fibrillation Quality of Life (AFEQT) | From baseline to 6 months PRIMARY ENDPOINT | The AFEQT is an atrial fibrillation-specific measure that taps into the QoL-domains: symptoms, daily activities, treatment concern, and treatment satisfaction. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Cardiac Anxiety Questionary (CAQ) | From baseline to 12 weeks | Symptom preoccupation |
| WHODAS 2.0 (12-item version) | From baseline to 6 months | General quality of life |
| Symptom checklist Severity and Frequency Scale (SCL) | From baseline to 12 weeks | AF related symptoms |
| Atrial Fibrillation Severity Scale | From baseline to 12 weeks | Symptomatic burden |
| Patient Health Questionnaire (PHQ-9) | From baseline to 12 weeks | Depression |
| PHQ-9 | From baseline to 6 months | Depression |
| Client satisfaction Questionnaire | From baseline to 12 weeks | Treatment satisfaction |
| Adverse events | From baseline to 12 weeks | Potential adverse reactions to the treatment |
| Electrocardiography (ECG) measurement | From baseline to 12 weeks | 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) |
| ECG measurement | From baseline to 6 months | 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) |
| the World Health Organization Disability Assessment Schedule (WHODAS 2.0, 12- item version) | From baseline to 12 weeks | General quality of life |
Other
| Measure | Time frame | Description |
|---|---|---|
| Healthcare consumption and work loss:Tic-P | From baseline to 12 weeks | 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). |
| Accelerometer | From baseline to 12 weeks | Objective measurement of physical activity 1 week |
| The International Physical Activity Questionnaire | From baseline to 6 months | Physical activity |
| Body Sensation Questionnaire | From baseline to 12 weeks | Fear of bodily sensations |
| Anxiety Sensitivity Index | From baseline to 12 weeks | Anxiety sensitivity |
| Perceived stress scale (4-item version) | From baseline to 12 weeks | Stress reactivity |
| Self-rated health, 1 item | From baseline to 12 weeks | The measure consists of a single item that asks the participants to rate their overall health as excellent, good, fair, or poor. |
Countries
Sweden
Outcome results
None listed