Internet-based Cognitive Behavior Therapy for Atrial Fibrillation

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.

Study Overview

• Status: Completed
• Conditions: Atrial Fibrillation; Arrhythmia
• Intervention / Treatment: Behavioral: Internet-based cognitive behavior therapy

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.

• Study Type: Interventional
• Enrollment (Actual): 19
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Sweden
  • Stockholm, Sweden
    • Department of Clinical Neuroscience, Karolinska Institutet

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 75 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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.

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. -

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm

Intervention / Treatment

Experimental: Internet-based cognitive behavior therapy; 10 sessions of ICBT during 10 weeks.

Behavioral: Internet-based cognitive behavior therapy; 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 fruitlessly aim to prevent triggering of AF episodes or 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change in 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
Change in 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.

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
WHODAS 2.0 (12-item version) •	Change in general quality of life	From baseline to 12 weeks.
WHODAS 2.0 (12-item version) •	Change in general quality of life:	From baseline to 9 months.
Symptom checklist (SCL)	Change in AF related symptoms:	From baseline to 12 weeks.
Symptom checklist (SCL)	Change in AF related symptoms:	From baseline to 9 months.
Atrial Fibrillation Severity Scale	Change in symptomatic burden	From baseline to 12 weeks.
Atrial Fibrillation Severity Scale	Change in symptomatic burden	From baseline to 9 months.
Cardiac Anxiety Questionnaire	Change in symptom preoccupation:	From baseline to 12 weeks.
Cardiac Anxiety Questionnaire	Change in symptom preoccupation	From baseline to 9 months.
GAD-7	Change in anxiety	From baseline to 12 weeks.
GAD-7	Change in anxiety	From baseline to 9 months.
PHQ-9	Change in depression:	From baseline to 12 weeks.
PHQ-9	Change in depression	From baseline to 9 months.
Perceived stress scale	Change in stress reactivity	From baseline to 12 weeks.
Perceived stress scale	Change in stress reactivity	From baseline to 9 months.
Change in healthcare consumption and work loss: TIC-P	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).	From baseline to 12 weeks.
Change in healthcare consumption and work loss: TIC-P	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).	From baseline to 9 months.
Change in symtomatic burden: Holter ECG.	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")	From baseline to 12 weeks.
Change in symptomatic burden: Holter ECG.	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")	From baseline to 9 months.

Collaborators and Investigators

• Sponsor: Karolinska Institutet
• Investigators: Study Director: Frieder Braunschweig, PhD, Karolinska Institutet

Publications and helpful links

General Publications

• Sarnholm J, Skuladottir H, Ruck C, Klaveback S, Olafsdottir E, Pedersen SS, Braunschweig F, Ljotsson B. Internet-Delivered Exposure-Based Therapy for Symptom Preoccupation in Atrial Fibrillation: Uncontrolled Pilot Trial. JMIR Cardio. 2021 Mar 2;5(1):e24524. doi: 10.2196/24524.

Study record dates

Study Major Dates

• Study Start: December 1, 2015
• Primary Completion (Actual): August 30, 2018
• Study Completion (Actual): August 30, 2018

Study Registration Dates

• First Submitted: December 14, 2015
• First Submitted That Met QC Criteria: February 23, 2016
• First Posted (Estimate): February 29, 2016

Study Record Updates

• Last Update Posted (Actual): August 21, 2019
• Last Update Submitted That Met QC Criteria: August 19, 2019
• Last Verified: August 1, 2019

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pathologic Processes; Heart Diseases; Cardiovascular Diseases; Arrhythmias, Cardiac; Atrial Fibrillation
• Other Study ID Numbers: AF pilot ICBT 2015