Internet-delivered Cognitive Behavior Therapy for Atrial Fibrillation

NCT ID: NCT03378349

Last Updated: 2020-09-23

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 126 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2018-01-08
• Study Completion Date: 2020-09-20

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.

Conditions

Atrial Fibrillation; Arrhythmia

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: CROSSOVER
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

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.

Group Type: EXPERIMENTAL

Internet-delivered cognitive behavior therapy

Intervention Type: BEHAVIORAL

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.

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.

Group Type: PLACEBO_COMPARATOR

Treatment as usual

Intervention Type: BEHAVIORAL

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.

Interventions

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.

Intervention Type: 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.

Intervention Type: BEHAVIORAL

Eligibility Criteria

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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 75 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Karolinska Institutet

OTHER

Sponsor Role: lead

Responsible Party

Brjann Ljotsson

Associate professor, PhD, Lic. psychologist

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

Karolinska universitetssjukhuset Solna

Stockholm, , Sweden

Countries

Sweden

References

Sarnholm J, Axelsson E, Skuladottir H, Bonnert M, Bragesjo M, Ruck C, Pedersen SS, Braunschweig F, Ljotsson B. The role of cardiac-related fear, hypervigilance, and avoidance behavior in exposure-based cognitive behavioral therapy for atrial fibrillation: A mediation analysis based on a randomized controlled trial. J Consult Clin Psychol. 2025 Aug;93(8):527-539. doi: 10.1037/ccp0000961.

Reference Type: DERIVED

PMID: 40811118 (View on PubMed)

Sarnholm J, Skuladottir H, Ruck C, Axelsson E, Bonnert M, Bragesjo M, Venkateshvaran A, Olafsdottir E, Pedersen SS, Ljotsson B, Braunschweig F. Cognitive Behavioral Therapy Improves Quality of Life in Patients With Symptomatic Paroxysmal Atrial Fibrillation. J Am Coll Cardiol. 2023 Jul 4;82(1):46-56. doi: 10.1016/j.jacc.2023.04.044.

Reference Type: DERIVED

PMID: 37380303 (View on PubMed)

Other Identifiers

AF RCT 1

Identifier Type: -

Identifier Source: org_study_id