Internet-delivered Cognitive Behavior Therapy for Atrial Fibrillation
Study Details
Study Description
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.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
N/A |
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.
Study Design
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Experimental: 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-delivered cognitive behavior therapy
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.
|
| Placebo Comparator: Treatment as usual wait list Patients randomized to the treatment as usual wait list arm will receive standardized AF information that emphasizes that an active physical and social lifestyle is necessary to maintain good health. Thus, the treatment as usual arm will control for the provision of basic patient information, but without the guidance of a psychologist or any CBT interventions. |
Behavioral: Treatment 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.
|
Outcome Measures
Primary Outcome Measures
- 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.
- The Atrial Fibrillation Quality of Life (AFEQT) [From baseline to 12 weeks]
The AFEQT is an atrial fibrillation-specific measure that taps into the QoL-domains: symptoms, daily activities, treatment concern, and treatment satisfaction.
- The Atrial Fibrillation Quality of Life (AFEQT) [From baseline to 9 months]
The AFEQT is an atrial fibrillation-specific measure that taps into the QoL-domains: symptoms, daily activities, treatment concern, and treatment satisfaction.
- The Atrial Fibrillation Quality of Life (AFEQT) [From baseline to 15 months]
The AFEQT is an atrial fibrillation-specific measure that taps into the QoL-domains: symptoms, daily activities, treatment concern, and treatment satisfaction.
Secondary Outcome Measures
- 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")
- ECG measurement [From baseline to 15 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")
- Cardiac Anxiety Questionary (CAQ) [From baseline to 12 weeks]
Symptom preoccupation
- Cardiac Anxiety Questionary (CAQ) [From baseline to 6 months]
Symptom preoccupation
- Cardiac Anxiety Questionary (CAQ) [From baseline to 9 months]
Symptom preoccupation
- Cardiac Anxiety Questionary (CAQ) [From baseline to 15 months]
Symptom preoccupation
- the World Health Organization Disability Assessment Schedule (WHODAS 2.0, 12- item version) [From baseline to 12 weeks]
General quality of life
- WHODAS 2.0 (12-item version) [From baseline to 6 months]
General quality of life
- WHODAS 2.0 (12-item version) [From baseline to 15 months]
General quality of life
- Symptom checklist Severity and Frequency Scale (SCL) [From baseline to 12 weeks]
AF related symptoms
- Symptom checklist Severity and Frequency Scale (SCL) [From baseline to 6 months]
AF related symptoms
- Symptom checklist Severity and Frequency Scale (SCL) [From baseline to 15 months]
AF related symptoms
- Atrial Fibrillation Severity Scale [From baseline to 12 weeks]
Symptomatic burden
- Atrial Fibrillation Severity Scale [From baseline to 6 months]
Symptomatic burden
- Atrial Fibrillation Severity Scale [From baseline to 15 months]
Symptomatic burden
- Patient Health Questionnaire (PHQ-9) [From baseline to 12 weeks]
Depression
- PHQ-9 [From baseline to 6 months]
Depression
- PHQ-9 [From baseline to 15 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
Other Outcome Measures
- 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.
- Self-rated health, 1 item [From baseline to 6 months]
The measure consists of a single item that asks the participants to rate their overall health as excellent, good, fair, or poor.
- Self-rated health, 1 item [From baseline to 15 months]
The measure consists of a single item that asks the participants to rate their overall health as excellent, good, fair, or poor.
- 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).
- Healthcare consumption and work loss:Tic-P [From baseline to 6 months]
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).
- Healthcare consumption and work loss:Tic-P [From baseline to 15 months]
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).
- The International Physical Activity Questionnaire [From baseline to 6 months]
Physical activity
- The International Physical Activity Questionnaire [From baseline to 12 weeks]
Physical activity
- The International Physical Activity Questionnaire [From baseline to 9 months]
Physical activity
- The International Physical Activity Questionnaire [From baseline to 15 months]
Physical activity
- Body Sensation Questionnaire [From baseline to 12 weeks]
Fear of bodily sensations
- Body Sensation Questionnaire [From baseline to 6 months]
Fear of bodily sensations
- Body Sensation Questionnaire [From baseline to 15 months]
Fear of bodily sensations
- Anxiety Sensitivity Index [From baseline to 12 weeks]
Anxiety sensitivity
- Anxiety Sensitivity Index [From baseline to 6 months]
Anxiety sensitivity
- Anxiety Sensitivity Index [From baseline to 15 months]
Anxiety sensitivity
- Accelerometer [From baseline to 12 weeks]
Objective measurement of physical activity 1 week
- Accelerometer [From baseline to 6 months]
Objective measurement of physical activity 1 week
- Accelerometer [From baseline to 15 months]
Objective measurement of physical activity 1 week
- Perceived stress scale (4-item version) [From baseline to 12 weeks]
Stress reactivity
- Perceived stress scale (4-item version) [From baseline to 6 months]
Stress reactivity
- Perceived stress scale (4-item version) [From baseline to 9 months]
Stress reactivity
- Perceived stress scale (4-item version) [From baseline to 15 months]
Stress reactivity
Eligibility Criteria
Criteria
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.
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Karolinska universitetssjukhuset Solna | Stockholm | Sweden |
Sponsors and Collaborators
- Karolinska Institutet
Investigators
None specified.Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- AF RCT 1