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

  • STATUS
    Recruiting
  • days left to enroll
    7
  • participants needed
    260
  • sponsor
    Karolinska Institutet
Updated on 7 April 2023
anxiety
fibrillation

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.

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.

Details
Condition Atrial Fibrillation, Arrythmia
Treatment Internet-deliviered exposure-based CBT, Internet-delivered stress management treatment
Clinical Study IdentifierNCT04962932
SponsorKarolinska Institutet
Last Modified on7 April 2023

Eligibility

Yes No Not Sure

Inclusion Criteria

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)
Scoring ≥ 20 on the Cardiac Anxiety Questionnaire at screening
Age 18-75 years
On optimal medical treatment
Able to read and write in Swedish

Exclusion Criteria

Heart failure with severe systolic dysfunction (ejection fraction ≤ 35%)
Significant valvular disease
Planned ablation for AF or ablation within 3 months before assessment
Other severe medical illness
Any medical restriction to physical exercise
Severe psychiatric disorder, severe depression, or risk of suicide
Alcohol dependency
Previous participation in any AF-CBT study conducted by the research group
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