Internet-based Cognitive Behavior Therapy for Atrial Fibrillation

Not Applicable

Completed

• Conditions: Arrhythmia; Atrial Fibrillation
• Interventions: Behavioral: Internet-based cognitive behavior therapy

• Registration Number: NCT02694276
• Lead Sponsor: Karolinska Institutet

Brief Summary

The aim is to evaluate if internet- delivered CBT, based on behavioral activation and exposure principles, improves wellbeing and QoL in symptomatic AF patients.The study will include 30 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.

Method: Pilot study with a pre-post-design and no control group. The internet-delivered CBT-program will last for 10 weeks and include weekly therapist support, consisting of online messages and telephone calls.

Basic Information
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Recruitment & Eligibility
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Study & Design
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Trial Locations

Study Timeline

• Study Start: 2015-12
• Study First Submitted: 2015-12-14
• Study First Submitted QC: 2016-02-23
• Study First Posted: 2016-02-29
• Primary Completion: 2018-08-30
• Study Completion: 2018-08-30
• Status Verified: 2019-08
• Last Update Submitted: 2019-08-19
• Last Update Posted: 2019-08-21

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 19

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) [31]; B) Age 18-75 years; C) Able to read and write in Swedish.

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Exclusion Criteria

C) Heart failure with severe systolic dysfunction (ejection fraction ≤ 35%); D) Significant valvular disease; E) Other severe medical illness; F) Severe depression or risk of suicide; G) Alcohol dependency. -

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Internet-based cognitive behavior therapy	Internet-based cognitive behavior therapy	10 sessions of ICBT during 10 weeks.

Primary Outcome Measures

Name	Time	Method
Change in The Atrial Fibrillation Quality of Life (AFEQT)	From baseline to 9 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
Change in symptomatic burden: Holter ECG.	From baseline to 9 months.	The patient will undergo a 24 h ECG assessment in order to measure objectively symptomatic burden (number and duration of symptomatic AF episodes and symptomatic "non-AF episodes")
WHODAS 2.0 (12-item version) •	From baseline to 9 months.	Change in general quality of life:
Symptom checklist (SCL)	From baseline to 9 months.	Change in AF related symptoms:
Atrial Fibrillation Severity Scale	From baseline to 9 months.	Change in symptomatic burden
Cardiac Anxiety Questionnaire	From baseline to 9 months.	Change in symptom preoccupation
GAD-7	From baseline to 9 months.	Change in anxiety
PHQ-9	From baseline to 9 months.	Change in depression
Perceived stress scale	From baseline to 9 months.	Change in stress reactivity
Change in healthcare consumption and work loss: TIC-P	From baseline to 9 months.	The Trimbos and Institute of Medical Technology Assessment Cost Questionnaire for Psychiatry assesses societal cost during the last month. These costs include the participant's health care consumption (direct medical costs), time spent in other health promoting activities (direct non-medical costs), and sick leave, unemployment, and reduced work capacity at work and in the domestic realm (indirect non-medical costs).
Change in symtomatic burden: Holter ECG.	From baseline to 12 weeks.	The patient will undergo a 24 h ECG assessment in order to measure objectively symptomatic burden (number and duration of symptomatic AF episodes and symptomatic "non-AF episodes")

Trial Locations

Locations (1)

Department of Clinical Neuroscience, Karolinska Institutet; 🇸🇪 Stockholm, Sweden