Internet-delivered Cognitive Behavior Therapy Compared to Stress Management for Atrial Fibrillation
Condition: Atrial Fibrillation; Arrythmia
MeSH terms: Atrial Fibrillation
Study type: Interventional

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.
    

Intervention name(s): Internet-deliviered exposure-based CBT; Internet-delivered stress management treatment
Intervention type(s): Behavioral; Behavioral
Intervention description(s): 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.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Participant)
Primary purpose: Treatment