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Completed

NCT Number: NCT02694276

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.

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Key information

Conditions

Atrial Fibrillation Arrhythmia Arrhythmias, Cardiac Cardiovascular Diseases Heart Diseases Pathologic Processes Pathological Conditions, Signs and Symptoms

Age range

18 year–75 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Department of Clinical Neuroscience, Karolinska Institutet

Stockholm, Sweden

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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. -

Treatment and study plan

Internet-based Cognitive Behavior Therapy

Behavioral

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.

Primary outcomes

  1. Change in 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.

  2. Change in 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.

Secondary outcomes

  1. WHODAS 2.0 (12-item version) •

    Time frame: From baseline to 12 weeks.

    Change in general quality of life

  2. WHODAS 2.0 (12-item version) •

    Time frame: From baseline to 9 months.

    Change in general quality of life:

  3. Symptom checklist (SCL)

    Time frame: From baseline to 12 weeks.

    Change in AF related symptoms:

  4. Symptom checklist (SCL)

    Time frame: From baseline to 9 months.

    Change in AF related symptoms:

  5. Atrial Fibrillation Severity Scale

    Time frame: From baseline to 12 weeks.

    Change in symptomatic burden

  6. Atrial Fibrillation Severity Scale

    Time frame: From baseline to 9 months.

    Change in symptomatic burden

  7. Cardiac Anxiety Questionnaire

    Time frame: From baseline to 12 weeks.

    Change in symptom preoccupation:

  8. Cardiac Anxiety Questionnaire

    Time frame: From baseline to 9 months.

    Change in symptom preoccupation

  9. GAD-7

    Time frame: From baseline to 12 weeks.

    Change in anxiety

  10. GAD-7

    Time frame: From baseline to 9 months.

    Change in anxiety

  11. PHQ-9

    Time frame: From baseline to 12 weeks.

    Change in depression:

  12. PHQ-9

    Time frame: From baseline to 9 months.

    Change in depression

  13. Perceived stress scale

    Time frame: From baseline to 12 weeks.

    Change in stress reactivity

  14. Perceived stress scale

    Time frame: From baseline to 9 months.

    Change in stress reactivity

  15. Change in 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).

  16. Change in healthcare consumption and work loss: TIC-P

    Time frame: 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).

  17. Change in symtomatic burden: Holter ECG.

    Time frame: 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")

  18. Change in symptomatic burden: Holter ECG.

    Time frame: 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")

Sponsors and collaborators

Lead sponsor

Karolinska Institutet

Other

Registry information

Important dates

Study start
2015
Primary completion
2018
Study completion
2018
First posted
Feb 29, 2016
Registry last updated
Aug 21, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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