NCT04962932

Internet-delivered Cognitive Behavior Therapy Compared to Stress Management for Atrial Fibrillation

Internet-delivered Cognitive Behavior Therapy Compared to Stress Management for Atrial Fibrillation- a Randomized Controlled Trial With Active Control

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 206 (actual)
• Sponsor: Karolinska Institutet · Academic / Other
• Sex: All
• Age: 18 Years – 75 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Atrial Fibrillation
• Arrythmia

Interventions

Type	Name	Description
BEHAVIORAL	Internet-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.
BEHAVIORAL	Internet-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.

Timeline

• Start date: 2021-08-13
• Primary completion: 2023-03-31
• Completion: 2023-10-05
• First posted: 2021-07-15
• Last updated: 2023-10-11

Locations

1 site across 1 country: Sweden