Internet-delivered Cognitive Behavior Therapy for Atrial Fibrillation

NCT03378349 | Completed

• 1 other identifier: AF RCT 1
• Study Type: interventional
• Target: 126
• Locations: 1 country
• Sites: 1

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.

Conditions

Atrial Fibrillation; Arrhythmia

Outcome Measures

Primary Outcomes (4)

• The Atrial Fibrillation Quality of Life (AFEQT)

  The AFEQT is an atrial fibrillation-specific measure that taps into the QoL-domains: symptoms, daily activities, treatment concern, and treatment satisfaction.

  From baseline to 6 months PRIMARY ENDPOINT

• The Atrial Fibrillation Quality of Life (AFEQT)

  The AFEQT is an atrial fibrillation-specific measure that taps into the QoL-domains: symptoms, daily activities, treatment concern, and treatment satisfaction.

  From baseline to 12 weeks

• The Atrial Fibrillation Quality of Life (AFEQT)

  The AFEQT is an atrial fibrillation-specific measure that taps into the QoL-domains: symptoms, daily activities, treatment concern, and treatment satisfaction.

  From baseline to 9 months

• The Atrial Fibrillation Quality of Life (AFEQT)

  The AFEQT is an atrial fibrillation-specific measure that taps into the QoL-domains: symptoms, daily activities, treatment concern, and treatment satisfaction.

  From baseline to 15 months

Secondary Outcomes (21)

• Electrocardiography (ECG) measurement

  From baseline to 12 weeks

• ECG measurement

  From baseline to 6 months

• ECG measurement

  From baseline to 15 months

• Cardiac Anxiety Questionary (CAQ)

  From baseline to 12 weeks

• Cardiac Anxiety Questionary (CAQ)

  From baseline to 6 months

Other Outcomes (23)

• Self-rated health, 1 item

  From baseline to 12 weeks

• Self-rated health, 1 item

  From baseline to 6 months

• Self-rated health, 1 item

  From baseline to 15 months

Study Arms (2)

Internet-delivered CBT over 10 weeks

EXPERIMENTAL

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.

Behavioral: Internet-delivered cognitive behavior therapy

Treatment as usual wait list

PLACEBO COMPARATOR

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.

Behavioral: Treatment as usual

Interventions

Internet-delivered cognitive behavior therapy 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.

Internet-delivered CBT over 10 weeks

Treatment as usual 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.

Treatment as usual wait list

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may not qualify if:

• (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.

Sponsors & Collaborators

• Karolinska Institutet: lead

Study Sites (1)

Karolinska universitetssjukhuset Solna

Stockholm, Sweden

Location

Related Publications (2)

• 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.

  PMID: 40811118 DERIVED

• 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.

  PMID: 37380303 DERIVED

MeSH Terms

Conditions

Atrial Fibrillation; Arrhythmias, Cardiac

Interventions

Therapeutics

Condition Hierarchy (Ancestors)

Heart Diseases; Cardiovascular Diseases; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate professor, PhD, Lic. psychologist

Study Record Dates

• First Submitted: December 11, 2017
• First Posted: December 19, 2017
• Study Start: January 8, 2018
• Primary Completion: December 20, 2019
• Study Completion: September 20, 2020
• Last Updated: September 23, 2020

Record last verified: 2020-09

Data Sharing

• IPD Sharing: Will not share

Locations

SE (1)