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Completed

NCT Number: NCT04962932

Internet-delivered Cognitive Behavior Therapy Compared to Stress Management for Atrial Fibrillation

The aim of this study 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), controlling for expectancy of improvement and attention from a caregiver, using an active control group (stress management). The study will include 260 patients with symptomatic AF despite optimal medical treatment in accordance with current guidelines.

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Key information

Conditions

Atrial Fibrillation Arrhythmias, Cardiac Arrythmia 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

Solna, 171 64, 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 controlling for expectancy of improvement and attention from a caregiver using an active control group receiving stress management treatment (SMT).

Method: A randomized controlled trial. Participants are randomized to internet- delivered exposure-based CBT (N=130) or to SMT (N=130). Participants in both groups receive weekly therapist support through online written communication. The internet-delivered SMT-treatment includes life-style advice (e.g., exercise, sleep advice), relaxation and problem-solving skills to reduce stress. Both treatments lasts 10 weeks and are comparable regarding number of treatment modules, treatment burden and attention from the treating psychologist.

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • 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);
  • Scoring ≥ 20 on the Cardiac Anxiety Questionnaire at screening;
  • Age 18-75 years;
  • On optimal medical treatment;
  • Able to read and write in Swedish.

Exclusion criteria

  • Heart failure with severe systolic dysfunction (ejection fraction ≤ 35%);
  • Significant valvular disease;
  • Planned ablation for AF or ablation within 3 months before assessment;
  • Other severe medical illness;
  • Any medical restriction to physical exercise;
  • Severe psychiatric disorder, severe depression, or risk of suicide;
  • Alcohol dependency;
  • Previous participation in any AF-CBT study conducted by the research group.

Treatment and study plan

Internet-deliviered exposure-based CBT

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.

Internet-delivered stress management treatment

Behavioral

The intervention last for 10 weeks and include: Internet-SMT include life-style advice (e.g., exercise, sleep advice), relaxation and problem-solving skills to reduce stress. Patients are offered regular online contact with a psychologist with the same frequency and intensity as in the CBT arm.

Primary outcomes

  1. Atrial Fibrillation Effect on Quality-of-Life modified for weekly assessment

    Time frame: Change over 11 measurement points measured from baseline and weekly for 10 weeks during treatment [PRIMARY ENDPOINT]

    The AFEQT is an atrial fibrillation-specific measure that taps into the QoL-domains: symptoms, daily activities, treatment concern, and treatment satisfaction. Total score ranges from 0 (severe symptoms and disability) to 100 (no symptoms and disability).

  2. Atrial Fibrillation Effect on Quality-of-Life modified for weekly assessment

    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. Total score ranges from 0 (severe symptoms and disability) to 100 (no symptoms and disability).

Secondary outcomes

  1. Cardiac Anxiety Questionnaire (CAQ)

    Time frame: From baseline to 10 weeks

    Measure of cardiac anxiety, fear, avoidance and attention. The score ranges between 0 and 72, with a greater score indicating elevated cardiac anxiety.

  2. Cardiac Anxiety Questionnaire (CAQ)

    Time frame: From baseline to 9 months

    Measure of cardiac anxiety, fear, avoidance and attention. The score ranges between 0 and 72, with a greater score indicating elevated cardiac anxiety.

  3. AF-avoidance behavior questionnaire

    Time frame: From baseline to 10 weeks

    Form measuring AF-specific avoidance- and control behaviors, developed by the research group

  4. AF-avoidance behavior questionnaire

    Time frame: From baseline to 9 months

    Form measuring AF-specific avoidance- and control behaviors, developed by the research group

  5. AF-avoidance behavior questionnaire modified for weekly assessment

    Time frame: Change over 11 measurement points measured from baseline and weekly for 10 weeks during treatment

    4 items from the AF-avoidance behavior questionnaire

  6. Short Form Health Survey (SF-12)

    Time frame: From baseline to 10 weeks

    General quality of life, with a score ranging from 0 to 100. A higher score indicating a better quality of life

  7. Short Form Health Survey (SF-12)

    Time frame: From baseline to 9 months

    General quality of life, with a score ranging from 0 to 100. A higher score indicating a better quality of life

  8. Atrial Fibrillation Severity Scale (4 items)

    Time frame: From baseline to 10 weeks

    4 items from the Atrial Fibrillation Severity Scale, measuring health care seeking

  9. Atrial Fibrillation Severity Scale (4 items)

    Time frame: From baseline to 9 months

    4 items from the Atrial Fibrillation Severity Scale, measuring health care seeking

  10. The Godin-Shepard Leisure-Time Physical Activity Questionnaire

    Time frame: From baseline to 10 weeks

    Level of physical activity. The participant rate numbers of time per week that they engage in physical activity. The numb ers are the categorized in to low, moderate, and high levels of physical activity.

  11. The Godin-Shepard Leisure-Time Physical Activity Questionnaire

    Time frame: From baseline to 9 months

    Level of physical activity. The participant rate numbers of time per week that they engage in physical activity. The numb ers are the categorized in to low, moderate, and high levels of physical activity.

  12. Body Sensation Questionnaire

    Time frame: From baseline to 10 weeks

    Fear of bodily symptoms, score ranging from 0 to 72 . Higher scores indicate more fear of body sensations.

  13. Body Sensation Questionnaire

    Time frame: From baseline to 9 months

    Fear of bodily symptoms, score ranging from 0 to 72 . Higher scores indicate more fear of body sensations.

  14. Patient Health Questionnaire-2

    Time frame: From baseline to 10 weeks

    Short form measuring depression, score ranging 0 to 6 with a higher score indicating higher level of depression.

  15. Patient Health Questionnaire-2

    Time frame: From baseline to 9 months

    Short form measuring depression, score ranging 0 to 6 ,with a higher score indicating higher level of depression.

  16. Perceived Stress Scale (4 items version)

    Time frame: From baseline to 10 weeks

    Measures perceived stress, score ranging from 0-16, with a higher score indicating higher level of perceived stress

  17. Perceived Stress Scale (4 items version)

    Time frame: From baseline to 9 months

    Measures perceived stress, score ranging from 0-16, with a higher score indicating higher level of perceived stress

  18. Generalized Anxiety Disorder-2 (GAD-2)

    Time frame: From baseline to 10 weeks

    General anxiety, score ranging from 0-6, with a higher score indicating more anxiety and worry.

  19. Generalized Anxiety Disorder-2

    Time frame: From baseline to 9 months

    General anxiety, score ranging from 0-6, with a higher score indicating more anxiety and worry.

  20. Insomnia Severity Index (5 items)

    Time frame: From baseline to 10 weeks

    Measure of insomnia, score ranging from 0-20, with a higher score indicating more severe insomnia

  21. Insomnia Severity Index (5 items)

    Time frame: From Baseline to 9 months

    Measure of insomnia, score ranging from 0-20, with a higher score indicating more severe insomnia

  22. Perceived Competence Scale

    Time frame: From baseline to 10 weeks

    Perception of AF-specific knowledge and competence, score ranging from 0- 50 with higher score indicating higher perceived competence

  23. Perceived Competence Scale

    Time frame: From baseline to 9 months

    Perception of AF-specific knowledge and competence, score ranging from 0- 50 with higher score indicating higher perceived competence

  24. Client Satisfaction Questionnaire

    Time frame: 10 weeks from baseline

    Treatment satisfaction, score ranging from 0-24, with a higher score indicating higher satisfaction with treatment.

  25. Adverse events

    Time frame: 10 weeks from baseline

    Potential adverse reactions to the treatment. Participants will be asked to report and rate the short- and long term discomfort of the adverse event on a scale from 0 ('did not affect me at all') and 3 ('affected me very negatively').

  26. Adverse events

    Time frame: 9 months from baseline

    Potential adverse reactions to the treatment. Participants will be asked to report and rate the short- and long term discomfort of the adverse event on a scale from 0 ('did not affect me at all') and 3 ('affected me very negatively').

  27. Symptoms Checklist Severity and Frequency Scale (SCL)

    Time frame: From baseline to 10 weeks

    AF-related symptoms

  28. Symptoms Checklist Severity and Frequency Scale (SCL)

    Time frame: From baseline to 9 months

    AF-related symptoms measured in two sub scales A) frequency: score ranging from 0-48, with higher score indicating higher frequency of symptoms, B) severity of experienced symptom: score ranging from 0- 48, with a higher score indicating more severe symptoms

  29. AFFS/SCL-4

    Time frame: Weekly from baseline to 10 weeks

    4 items derived from the Symptoms Checklist (SCL) and the Atrial Fibrillation Severity Scale (AFSS) measuring disabling cardiac symptoms not specified in AFEQT

  30. AFFS/SCL-4

    Time frame: From baseline to 9 months

    4 items derived from the Symptoms Checklist (SCL) and the Atrial Fibrillation Severity Scale (AFSS) measuring disabling cardiac symptoms not specified in AFEQT

Other outcomes

  1. Psychosocial stressors and changes in physical health

    Time frame: 10 weeks from baseline

    Participants are asked about their self-perceived health and if they have experienced any stressful event that they believe have affected their health (e.g severe disease, death of close relative, divorce)

  2. Psychosocial stressors and changes in physical health

    Time frame: 9 months from baseline

    Participants are asked about their self-perceived health and if they have experienced any stressful event that they believe have affected their health (e.g severe disease, death of close relative, divorce)

  3. Background data

    Time frame: Baseline

    Demographics, list of medications, co-morbidity, smoking history and alcohol consumption

  4. Treatment Credibility Scale

    Time frame: 2-4 weeks from baseline

    Measures treatment credibility

  5. Working Alliance Inventory

    Time frame: 2-4 weeks from baseline

    Measures therapeutic alliance with the psychologist

  6. Changes in medication

    Time frame: 10 weeks from baseline

    Participants are asked if they have made any changes in medication

  7. Changes in medication

    Time frame: 9 months from baseline

    Participants are asked if they have made any changes in medication

Sponsors and collaborators

Lead sponsor

Karolinska Institutet

Other

Collaborators

  • Karolinska University Hospital

Registry information

Official study title

Internet-delivered Cognitive Behavior Therapy Compared to Stress Management for Atrial Fibrillation- a Randomized Controlled Trial With Active Control

Important dates

Study start
2021
Primary completion
2023
Study completion
2023
First posted
Jul 15, 2021
Registry last updated
Oct 11, 2023

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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