Internet-delivered Cognitive Behavior Therapy for Atrial Fibrillation

September 21, 2020 updated by: Brjann Ljotsson, Karolinska Institutet

Internet-delivered Cognitive Behavior Therapy for Atrial Fibrillation - a Randomized Controlled Trial

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.

Study Overview

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 Type

Interventional

Enrollment (Actual)

126

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

      • Stockholm, Sweden
        • Karolinska Universitetssjukhuset Solna

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

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:

  • 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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Crossover Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Internet-delivered CBT over 10 weeks
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.
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.
Placebo Comparator: Treatment as usual wait list
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.
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
The Atrial Fibrillation Quality of Life (AFEQT)
Time Frame: From baseline to 6 months PRIMARY ENDPOINT
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)
Time Frame: From baseline to 12 weeks
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)
Time Frame: 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.
From baseline to 9 months
The Atrial Fibrillation Quality of Life (AFEQT)
Time Frame: 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.
From baseline to 15 months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Electrocardiography (ECG) measurement
Time Frame: 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")
From baseline to 12 weeks
ECG measurement
Time Frame: From baseline to 6 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")
From baseline to 6 months
ECG measurement
Time Frame: 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")
From baseline to 15 months
Cardiac Anxiety Questionary (CAQ)
Time Frame: From baseline to 12 weeks
Symptom preoccupation
From baseline to 12 weeks
Cardiac Anxiety Questionary (CAQ)
Time Frame: From baseline to 6 months
Symptom preoccupation
From baseline to 6 months
Cardiac Anxiety Questionary (CAQ)
Time Frame: From baseline to 9 months
Symptom preoccupation
From baseline to 9 months
Cardiac Anxiety Questionary (CAQ)
Time Frame: From baseline to 15 months
Symptom preoccupation
From baseline to 15 months
the World Health Organization Disability Assessment Schedule (WHODAS 2.0, 12- item version)
Time Frame: From baseline to 12 weeks
General quality of life
From baseline to 12 weeks
WHODAS 2.0 (12-item version)
Time Frame: From baseline to 6 months
General quality of life
From baseline to 6 months
WHODAS 2.0 (12-item version)
Time Frame: From baseline to 15 months
General quality of life
From baseline to 15 months
Symptom checklist Severity and Frequency Scale (SCL)
Time Frame: From baseline to 12 weeks
AF related symptoms
From baseline to 12 weeks
Symptom checklist Severity and Frequency Scale (SCL)
Time Frame: From baseline to 6 months
AF related symptoms
From baseline to 6 months
Symptom checklist Severity and Frequency Scale (SCL)
Time Frame: From baseline to 15 months
AF related symptoms
From baseline to 15 months
Atrial Fibrillation Severity Scale
Time Frame: From baseline to 12 weeks
Symptomatic burden
From baseline to 12 weeks
Atrial Fibrillation Severity Scale
Time Frame: From baseline to 6 months
Symptomatic burden
From baseline to 6 months
Atrial Fibrillation Severity Scale
Time Frame: From baseline to 15 months
Symptomatic burden
From baseline to 15 months
Patient Health Questionnaire (PHQ-9)
Time Frame: From baseline to 12 weeks
Depression
From baseline to 12 weeks
PHQ-9
Time Frame: From baseline to 6 months
Depression
From baseline to 6 months
PHQ-9
Time Frame: From baseline to 15 months
Depression
From baseline to 15 months
Client satisfaction Questionnaire
Time Frame: From baseline to 12 weeks
Treatment satisfaction
From baseline to 12 weeks
Adverse events
Time Frame: From baseline to 12 weeks
Potential adverse reactions to the treatment
From baseline to 12 weeks

Other Outcome Measures

Outcome Measure
Measure Description
Time Frame
Self-rated health, 1 item
Time Frame: From baseline to 12 weeks
The measure consists of a single item that asks the participants to rate their overall health as excellent, good, fair, or poor.
From baseline to 12 weeks
Self-rated health, 1 item
Time Frame: From baseline to 6 months
The measure consists of a single item that asks the participants to rate their overall health as excellent, good, fair, or poor.
From baseline to 6 months
Self-rated health, 1 item
Time Frame: From baseline to 15 months
The measure consists of a single item that asks the participants to rate their overall health as excellent, good, fair, or poor.
From baseline to 15 months
Healthcare consumption and work loss:Tic-P
Time Frame: From baseline to 12 weeks
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
Healthcare consumption and work loss:Tic-P
Time Frame: From baseline to 6 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).
From baseline to 6 months
Healthcare consumption and work loss:Tic-P
Time Frame: From baseline to 15 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).
From baseline to 15 months
The International Physical Activity Questionnaire
Time Frame: From baseline to 6 months
Physical activity
From baseline to 6 months
The International Physical Activity Questionnaire
Time Frame: From baseline to 12 weeks
Physical activity
From baseline to 12 weeks
The International Physical Activity Questionnaire
Time Frame: From baseline to 9 months
Physical activity
From baseline to 9 months
The International Physical Activity Questionnaire
Time Frame: From baseline to 15 months
Physical activity
From baseline to 15 months
Body Sensation Questionnaire
Time Frame: From baseline to 12 weeks
Fear of bodily sensations
From baseline to 12 weeks
Body Sensation Questionnaire
Time Frame: From baseline to 6 months
Fear of bodily sensations
From baseline to 6 months
Body Sensation Questionnaire
Time Frame: From baseline to 15 months
Fear of bodily sensations
From baseline to 15 months
Anxiety Sensitivity Index
Time Frame: From baseline to 12 weeks
Anxiety sensitivity
From baseline to 12 weeks
Anxiety Sensitivity Index
Time Frame: From baseline to 6 months
Anxiety sensitivity
From baseline to 6 months
Anxiety Sensitivity Index
Time Frame: From baseline to 15 months
Anxiety sensitivity
From baseline to 15 months
Accelerometer
Time Frame: From baseline to 12 weeks
Objective measurement of physical activity 1 week
From baseline to 12 weeks
Accelerometer
Time Frame: From baseline to 6 months
Objective measurement of physical activity 1 week
From baseline to 6 months
Accelerometer
Time Frame: From baseline to 15 months
Objective measurement of physical activity 1 week
From baseline to 15 months
Perceived stress scale (4-item version)
Time Frame: From baseline to 12 weeks
Stress reactivity
From baseline to 12 weeks
Perceived stress scale (4-item version)
Time Frame: From baseline to 6 months
Stress reactivity
From baseline to 6 months
Perceived stress scale (4-item version)
Time Frame: From baseline to 9 months
Stress reactivity
From baseline to 9 months
Perceived stress scale (4-item version)
Time Frame: From baseline to 15 months
Stress reactivity
From baseline to 15 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

January 8, 2018

Primary Completion (Actual)

December 20, 2019

Study Completion (Actual)

September 20, 2020

Study Registration Dates

First Submitted

December 11, 2017

First Submitted That Met QC Criteria

December 18, 2017

First Posted (Actual)

December 19, 2017

Study Record Updates

Last Update Posted (Actual)

September 23, 2020

Last Update Submitted That Met QC Criteria

September 21, 2020

Last Verified

September 1, 2020

More Information

Terms related to this study

Other Study ID Numbers

  • AF RCT 1

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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