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Completed

NCT Number: NCT03378349

Internet-delivered Cognitive Behavior Therapy for Atrial Fibrillation

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.

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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

Karolinska universitetssjukhuset Solna

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 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.

Who can participate

Healthy volunteers accepted: No

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

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.

Treatment and study plan

Internet-delivered Cognitive Behavior Therapy

Behavioral

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 Usual

Behavioral

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.

Primary outcomes

  1. 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.

  2. 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.

  3. 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.

  4. 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.

Secondary outcomes

  1. 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")

  2. 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")

  3. 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")

  4. Cardiac Anxiety Questionary (CAQ)

    Time frame: From baseline to 12 weeks

    Symptom preoccupation

  5. Cardiac Anxiety Questionary (CAQ)

    Time frame: From baseline to 6 months

    Symptom preoccupation

  6. Cardiac Anxiety Questionary (CAQ)

    Time frame: From baseline to 9 months

    Symptom preoccupation

  7. Cardiac Anxiety Questionary (CAQ)

    Time frame: From baseline to 15 months

    Symptom preoccupation

  8. the World Health Organization Disability Assessment Schedule (WHODAS 2.0, 12- item version)

    Time frame: From baseline to 12 weeks

    General quality of life

  9. WHODAS 2.0 (12-item version)

    Time frame: From baseline to 6 months

    General quality of life

  10. WHODAS 2.0 (12-item version)

    Time frame: From baseline to 15 months

    General quality of life

  11. Symptom checklist Severity and Frequency Scale (SCL)

    Time frame: From baseline to 12 weeks

    AF related symptoms

  12. Symptom checklist Severity and Frequency Scale (SCL)

    Time frame: From baseline to 6 months

    AF related symptoms

  13. Symptom checklist Severity and Frequency Scale (SCL)

    Time frame: From baseline to 15 months

    AF related symptoms

  14. Atrial Fibrillation Severity Scale

    Time frame: From baseline to 12 weeks

    Symptomatic burden

  15. Atrial Fibrillation Severity Scale

    Time frame: From baseline to 6 months

    Symptomatic burden

  16. Atrial Fibrillation Severity Scale

    Time frame: From baseline to 15 months

    Symptomatic burden

  17. Patient Health Questionnaire (PHQ-9)

    Time frame: From baseline to 12 weeks

    Depression

  18. PHQ-9

    Time frame: From baseline to 6 months

    Depression

  19. PHQ-9

    Time frame: From baseline to 15 months

    Depression

  20. Client satisfaction Questionnaire

    Time frame: From baseline to 12 weeks

    Treatment satisfaction

  21. Adverse events

    Time frame: From baseline to 12 weeks

    Potential adverse reactions to the treatment

Other outcomes

  1. 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.

  2. 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.

  3. 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.

  4. 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).

  5. 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).

  6. 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).

  7. The International Physical Activity Questionnaire

    Time frame: From baseline to 6 months

    Physical activity

  8. The International Physical Activity Questionnaire

    Time frame: From baseline to 12 weeks

    Physical activity

  9. The International Physical Activity Questionnaire

    Time frame: From baseline to 9 months

    Physical activity

  10. The International Physical Activity Questionnaire

    Time frame: From baseline to 15 months

    Physical activity

  11. Body Sensation Questionnaire

    Time frame: From baseline to 12 weeks

    Fear of bodily sensations

  12. Body Sensation Questionnaire

    Time frame: From baseline to 6 months

    Fear of bodily sensations

  13. Body Sensation Questionnaire

    Time frame: From baseline to 15 months

    Fear of bodily sensations

  14. Anxiety Sensitivity Index

    Time frame: From baseline to 12 weeks

    Anxiety sensitivity

  15. Anxiety Sensitivity Index

    Time frame: From baseline to 6 months

    Anxiety sensitivity

  16. Anxiety Sensitivity Index

    Time frame: From baseline to 15 months

    Anxiety sensitivity

  17. Accelerometer

    Time frame: From baseline to 12 weeks

    Objective measurement of physical activity 1 week

  18. Accelerometer

    Time frame: From baseline to 6 months

    Objective measurement of physical activity 1 week

  19. Accelerometer

    Time frame: From baseline to 15 months

    Objective measurement of physical activity 1 week

  20. Perceived stress scale (4-item version)

    Time frame: From baseline to 12 weeks

    Stress reactivity

  21. Perceived stress scale (4-item version)

    Time frame: From baseline to 6 months

    Stress reactivity

  22. Perceived stress scale (4-item version)

    Time frame: From baseline to 9 months

    Stress reactivity

  23. Perceived stress scale (4-item version)

    Time frame: From baseline to 15 months

    Stress reactivity

Sponsors and collaborators

Lead sponsor

Karolinska Institutet

Other

Registry information

Official study title

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

Important dates

Study start
2018
Primary completion
2019
Study completion
2020
First posted
Dec 19, 2017
Registry last updated
Sep 23, 2020

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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