Clinical trial NCT03378349: Internet-delivered Cognitive Behavior Therapy for Atrial Fibrillation
Official title: Internet-delivered Cognitive Behavior Therapy for Atrial Fibrillation - a Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Atrial Fibrillation
Arrhythmia
Lead sponsor: Karolinska Institutet
Sponsor class: OTHER
First posted: 2017-12-19
Enrollment: 126
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

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.

Eligibility 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.

Primary outcomes:
measure: The Atrial Fibrillation Quality of Life (AFEQT)
timeFrame: From baseline to 6 months PRIMARY ENDPOINT
measure: The Atrial Fibrillation Quality of Life (AFEQT)
timeFrame: From baseline to 12 weeks
measure: The Atrial Fibrillation Quality of Life (AFEQT)
timeFrame: From baseline to 9 months
measure: The Atrial Fibrillation Quality of Life (AFEQT)
timeFrame: From baseline to 15 months
Secondary outcomes:
measure: Electrocardiography (ECG) measurement
timeFrame: From baseline to 12 weeks
measure: ECG measurement
timeFrame: From baseline to 6 months
measure: ECG measurement
timeFrame: From baseline to 15 months
measure: Cardiac Anxiety Questionary (CAQ)
timeFrame: From baseline to 12 weeks
measure: Cardiac Anxiety Questionary (CAQ)
timeFrame: From baseline to 6 months
measure: Cardiac Anxiety Questionary (CAQ)
timeFrame: From baseline to 9 months
measure: Cardiac Anxiety Questionary (CAQ)
timeFrame: From baseline to 15 months
measure: the World Health Organization Disability Assessment Schedule (WHODAS 2.0, 12- item version)
timeFrame: From baseline to 12 weeks
measure: WHODAS 2.0 (12-item version)
timeFrame: From baseline to 6 months
measure: WHODAS 2.0 (12-item version)
timeFrame: From baseline to 15 months
measure: Symptom checklist Severity and Frequency Scale (SCL)
timeFrame: From baseline to 12 weeks
measure: Symptom checklist Severity and Frequency Scale (SCL)
timeFrame: From baseline to 6 months
measure: Symptom checklist Severity and Frequency Scale (SCL)
timeFrame: From baseline to 15 months
measure: Atrial Fibrillation Severity Scale
timeFrame: From baseline to 12 weeks
measure: Atrial Fibrillation Severity Scale
timeFrame: From baseline to 6 months
measure: Atrial Fibrillation Severity Scale
timeFrame: From baseline to 15 months
measure: Patient Health Questionnaire (PHQ-9)
timeFrame: From baseline to 12 weeks
measure: PHQ-9
timeFrame: From baseline to 6 months
measure: PHQ-9
timeFrame: From baseline to 15 months
measure: Client satisfaction Questionnaire
timeFrame: From baseline to 12 weeks
measure: Adverse events
timeFrame: From baseline to 12 weeks
Other outcomes:
measure: Self-rated health, 1 item
timeFrame: From baseline to 12 weeks
measure: Self-rated health, 1 item
timeFrame: From baseline to 6 months
measure: Self-rated health, 1 item
timeFrame: From baseline to 15 months
measure: Healthcare consumption and work loss:Tic-P
timeFrame: From baseline to 12 weeks
measure: Healthcare consumption and work loss:Tic-P
timeFrame: From baseline to 6 months
measure: Healthcare consumption and work loss:Tic-P
timeFrame: From baseline to 15 months
measure: The International Physical Activity Questionnaire
timeFrame: From baseline to 6 months
measure: The International Physical Activity Questionnaire
timeFrame: From baseline to 12 weeks
measure: The International Physical Activity Questionnaire
timeFrame: From baseline to 9 months
measure: The International Physical Activity Questionnaire
timeFrame: From baseline to 15 months
measure: Body Sensation Questionnaire
timeFrame: From baseline to 12 weeks
measure: Body Sensation Questionnaire
timeFrame: From baseline to 6 months
measure: Body Sensation Questionnaire
timeFrame: From baseline to 15 months
measure: Anxiety Sensitivity Index
timeFrame: From baseline to 12 weeks
measure: Anxiety Sensitivity Index
timeFrame: From baseline to 6 months
measure: Anxiety Sensitivity Index
timeFrame: From baseline to 15 months
measure: Accelerometer
timeFrame: From baseline to 12 weeks
measure: Accelerometer
timeFrame: From baseline to 6 months
measure: Accelerometer
timeFrame: From baseline to 15 months
measure: Perceived stress scale (4-item version)
timeFrame: From baseline to 12 weeks
measure: Perceived stress scale (4-item version)
timeFrame: From baseline to 6 months
measure: Perceived stress scale (4-item version)
timeFrame: From baseline to 9 months
measure: Perceived stress scale (4-item version)
timeFrame: From baseline to 15 months
Locations:
city: Stockholm
country: Sweden
facility: Karolinska universitetssjukhuset Solna
Study officials:
References: