Internet-delivered Cognitive Behavior Therapy for Atrial Fibrillation

Karolinska Institutet126 enrolled

Overview

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.

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 Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Enrollment

126

Conditions

Atrial Fibrillation Arrhythmia

Interventions

Internet-delivered cognitive behavior therapyBEHAVIORAL

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 usualBEHAVIORAL

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.

Eligibility

Sex: ALLMin age: 18 YearsMax age: 75 Years

Medical Language ↔ Plain English

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.

Locations (1)

Karolinska universitetssjukhuset Solna

Stockholm, Sweden

Outcomes

Primary Outcomes

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.

Time frame: 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.

Time frame: 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.

Time frame: 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.

Time frame: From baseline to 15 months

Secondary Outcomes

Electrocardiography (ECG) measurement

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")

Time frame: From baseline to 12 weeks

ECG measurement

Data from ClinicalTrials.gov

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