Internet-delivered Cognitive Behavior Therapy for Atrial Fibrillation

Not Applicable

Completed

• Conditions: Atrial Fibrillation; Arrhythmia

• Registration Number: NCT03378349
• Lead Sponsor: Karolinska Institutet

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.

Study Timeline

• Study First Submitted: 2017-12-11
• Study First Submitted QC: 2017-12-18
• Study First Posted: 2017-12-19
• Study Start: 2018-01-08
• Primary Completion: 2019-12-20
• Status Verified: 2020-09
• Study Completion: 2020-09-20
• Last Update Submitted: 2020-09-21
• Last Update Posted: 2020-09-23

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 126

Inclusion Criteria

• Inclusion criteria: A) 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) ; B) Age 18-75 years; C) On optimal medical treatment; D). Able to read and write in Swedish.

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Primary Outcome Measures

Name	Time	Method
The Atrial Fibrillation Quality of Life (AFEQT)	From baseline to 15 months	The AFEQT is an atrial fibrillation-specific measure that taps into the QoL-domains: symptoms, daily activities, treatment concern, and treatment satisfaction.

Secondary Outcome Measures

Name	Time	Method
Symptom checklist Severity and Frequency Scale (SCL)	From baseline to 15 months	AF related symptoms
Patient Health Questionnaire (PHQ-9)	From baseline to 12 weeks	Depression
ECG measurement	From baseline to 15 months	Change in symptomatic burden. The patient will undergo 5 days ECG assessment in order to measure objectively symptomatic burden (number and duration of symptomatic AF episodes and symptomatic "non-AF episodes")
the World Health Organization Disability Assessment Schedule (WHODAS 2.0, 12- item version)	From baseline to 12 weeks	General quality of life
Electrocardiography (ECG) measurement	From baseline to 12 weeks	Change in symptomatic burden. The patient will undergo 5 days ECG assessment in order to measure objectively symptomatic burden (number and duration of symptomatic AF episodes and symptomatic "non-AF episodes")
Cardiac Anxiety Questionary (CAQ)	From baseline to 15 months	Symptom preoccupation
Atrial Fibrillation Severity Scale	From baseline to 15 months	Symptomatic burden
Client satisfaction Questionnaire	From baseline to 12 weeks	Treatment satisfaction
PHQ-9	From baseline to 15 months	Depression
Adverse events	From baseline to 12 weeks	Potential adverse reactions to the treatment
WHODAS 2.0 (12-item version)	From baseline to 15 months	General quality of life

Trial Locations

Locations (1)

Karolinska universitetssjukhuset Solna; 🇸🇪 Stockholm, Sweden