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Completed

NCT Number: NCT05087238

CBT for Premature Ventricular Contractions

The purpose of the present interdisciplinary research program is to develop and evaluate a disease-specific cognitive behavior therapy (CBT) protocol to increase quality of life (QoL) and reduce symptom burden in patients with Premature Ventricular Contractions (PVC).

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Key information

Conditions

Ventricular Premature Complexes Arrhythmias, Cardiac Cardiac Complexes, Premature Cardiac Conduction System Disease Cardiovascular Diseases Heart Diseases Pathologic Processes Pathological Conditions, Signs and Symptoms

Age range

18 year–70 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Karolinska University Hospital

Stockholm, Sweden

About this study

Patients will be recruited in collaboration with arrythmia specialist units in Stockholm and through advertisement in local newspapers and social media. All patients giving informed consent will be screened thoroughly by the research nurse and a psychologist before included by the study cardiologist. 20-30 patients that meet eligibility criteria will be included and receive 8-10 sessions of cognitive behavior therapy during 8-10 weeks. Due to the current Covid-19 pandemic, treatment will be delivered face-to face through a secure digital platform. The psychologist delivering the treatment will have direct access to the study cardiologist during treatment. Follow-up at 3 and 6 months.

Who can participate

Healthy volunteers accepted: Yes

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

Inclusion

  • 18-70 years old
  • PVCs that cause moderate to severe symptoms and leads to significant distress or interferes with daily life.
  • Optimal medical treatment in the opinion of the treating physician.
  • Able to read and write in Swedish.

Exclusion

  • Structural heart disease including previous myocardial infarction, heart failure with preserved or reduced left ventricular ejection fraction, valvular disease, previous cardiac surgery.
  • Other arrhythmia or severe medical illness;
  • Scheduled for ablation therapy or any other cardiovascular intervention
  • Any medical restriction to physical exercise.
  • Severe depression or risk of suicide;
  • Alcohol dependency.

All patients will undergo thorough cardiological and psychological assessment to ensure that eligibility criteria are met.

Treatment and study plan

CBT

Behavioral

Cognitive Behavior Therapy for PVC-specific anxiety education, in-vivo exposure, interoceptive exposure, behavioral activation, relapse prevention

Primary outcomes

  1. Premature Ventricular Contractions effect on Quality-of-life (PVCEQT)

    Time frame: baseline

    Version of the Atrial Fibrillation effects on Quality-of-life (AFEQT), adjusted to Premature Ventricular Contractions. Measures PVC-specific Quality of life in several domains. 14 questions graded on a 7 points likert scale. The total score ranges between 0 (severe symptoms and disability) and 98 (no symptoms and disability)

  2. Premature Ventricular Contractions effect on Quality-of-life (PVCEQT)

    Time frame: 10 weeks from baseline

    Version of the Atrial Fibrillation effects on Quality-of-life (AFEQT), adjusted to Premature Ventricular Contractions. Measures PVC-specific Quality of life in several domains. 14 questions graded on a 7 points likert scale. The total score ranges between 0 (severe symptoms and disability) and 98 (no symptoms and disability)

  3. Premature Ventricular Contractions effect on Quality-of-life (PVCEQT)

    Time frame: 5 months from baseline

    Version of the Atrial Fibrillation effects on Quality-of-life (AFEQT), adjusted to Premature Ventricular Contractions. Measures PVC-specific Quality of life in several domains. 14 questions graded on a 7 points likert scale. The total score ranges between 0 (severe symptoms and disability) and 98 (no symptoms and disability)

  4. Premature Ventricular Contractions effect on Quality-of-life (PVCEQT)

    Time frame: 8 months from baseline

    Version of the Atrial Fibrillation effects on Quality-of-life (AFEQT), adjusted to Premature Ventricular Contractions. Measures PVC-specific Quality of life in several domains. 14 questions graded on a 7 points likert scale. The total score ranges between 0 (severe symptoms and disability) and 98 (no symptoms and disability)

Secondary outcomes

  1. 12-Item Short-Form Health Survey (SF-12)

    Time frame: baseline

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

  2. 12-Item Short-Form Health Survey (SF-12)

    Time frame: 10 weeks from baseline

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

  3. 12-Item Short-Form Health Survey (SF-12)

    Time frame: 5 months from baseline

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

  4. 12-Item Short-Form Health Survey (SF-12)

    Time frame: 8 months from baseline

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

  5. Symptom Checklist (SCL)

    Time frame: baseline

    Measures frequency and severity of 16 symptoms often experienced by patients with Atrial Fibrillation. Scoring range from 0 to 64 for frequency with a greater score indicating more frequent symptoms, and from range from 0 to 48 for severity, with a greater score indicating more severe symptoms. For total score sub scores are summed

  6. Symptom Checklist (SCL)

    Time frame: 10 weeks from baseline

    Measures frequency and severity of 16 symptoms often experienced by patients with Atrial Fibrillation. Scoring range from 0 to 64 for frequency with a greater score indicating more frequent symptoms, and from range from 0 to 48 for severity, with a greater score indicating more severe symptoms. For total score sub scores are summed

  7. Symptom Checklist (SCL)

    Time frame: 5 months from baseline

    Measures frequency and severity of 16 symptoms often experienced by patients with Atrial Fibrillation. Scoring range from 0 to 64 for frequency with a greater score indicating more frequent symptoms, and from range from 0 to 48 for severity, with a greater score indicating more severe symptoms. For total score sub scores are summed

  8. Symptom Checklist (SCL)

    Time frame: 8 months from baseline

    Measures frequency and severity of 16 symptoms often experienced by patients with Atrial Fibrillation. Scoring range from 0 to 64 for frequency with a greater score indicating more frequent symptoms, and from range from 0 to 48 for severity, with a greater score indicating more severe symptoms. For total score sub scores are summed

  9. Arrhythmia burden

    Time frame: baseline

    Number of premature ventricular contractions per 24 hours is assessed by 5-day ECG Holter-monitoring

  10. Arrhythmia burden

    Time frame: 10 weeks from baseline

    Number of premature ventricular contractions per 24 hours is assessed by 5-day ECG Holter-monitoring

  11. Arrhythmia burden

    Time frame: 8 months from baseline

    Number of premature ventricular contractions per 24 hours is assessed by 5-day ECG Holter-monitoring

  12. Cardiac anxiety questionnaire (CAQ)

    Time frame: baseline

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

  13. Cardiac anxiety questionnaire (CAQ)

    Time frame: 10 weeks from baseline

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

  14. Cardiac anxiety questionnaire (CAQ)

    Time frame: 5 months from baseline

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

  15. Cardiac anxiety questionnaire (CAQ)

    Time frame: 8 months from baseline

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

Other outcomes

  1. Patient Health Questionnaire-9 (PHQ-9)

    Time frame: baseline

    The PHQ-9 (26) is a well-established measure of depression, score ranging 0 to 27 with a higher score indicating higher level of depression.

  2. Patient Health Questionnaire-9 (PHQ-9)

    Time frame: 10 weeks from baseline

    The PHQ-9 (26) is a well-established measure of depression, score ranging 0 to 27 with a higher score indicating higher level of depression.

  3. Patient Health Questionnaire-9 (PHQ-9)

    Time frame: 5 months from baseline

    The PHQ-9 is a well-established measure of depression, score ranging 0 to 27 with a higher score indicating higher level of depression.

  4. Patient Health Questionnaire-9 (PHQ-9)

    Time frame: 8 months from baseline

    The PHQ-9 is a well-established measure of depression, score ranging 0 to 27 with a higher score indicating higher level of depression.

  5. Generalized Anxiety Disorder 7-item (GAD-7)

    Time frame: baseline

    General anxiety, score ranging from 0-21, with a higher score indicating more anxiety and worry.

  6. Generalized Anxiety Disorder 7-item (GAD-7)

    Time frame: 10 weeks from baseline

    General anxiety, score ranging from 0-21, with a higher score indicating more anxiety and worry.

  7. Generalized Anxiety Disorder 7-item (GAD-7)

    Time frame: 5 months from baseline

    General anxiety, score ranging from 0-21, with a higher score indicating more anxiety and worry.

  8. Generalized Anxiety Disorder 7-item (GAD-7)

    Time frame: 8 months from baseline

    General anxiety, score ranging from 0-21, with a higher score indicating more anxiety and worry.

  9. Godin Shepard Leisure-time Physical Activity Questionnaire (GSLTPAQ)

    Time frame: baseline

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

    measures changes in physical activity.

  10. Godin Shepard Leisure-time Physical Activity Questionnaire (GSLTPAQ)

    Time frame: 10 weeks from baseline

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

    measures changes in physical activity.

  11. Godin Shepard Leisure-time Physical Activity Questionnaire (GSLTPAQ)

    Time frame: 5 months from baseline

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

    measures changes in physical activity.

  12. Godin Shepard Leisure-time Physical Activity Questionnaire (GSLTPAQ)

    Time frame: 8 months from baseline

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

    measures changes in physical activity.

  13. Body Sensation Questionnaire (BSQ)

    Time frame: baseline

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

  14. Body Sensation Questionnaire (BSQ)

    Time frame: 10 weeks from baseline

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

  15. Body Sensation Questionnaire (BSQ)

    Time frame: 5 months from baseline

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

  16. Body Sensation Questionnaire (BSQ)

    Time frame: 8 months from baseline

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

  17. Client satisfaction Questionnaire (CSQ)

    Time frame: 10 weeks from baseline

    Measures treatment satisfaction, score ranging from 0 to 32, with a higher score indication more satisfaction with the treatment.

  18. The Perceived stress scale (PSS-10)

    Time frame: baseline

    Measures levels of perceived stress, score ranging from 0 to 40, with a higher score indicating higher levels of experienced stress,

  19. The Perceived stress scale (PSS-10)

    Time frame: 10 weeks from baseline

    Measures levels of perceived stress, score ranging from 0 to 40, with a higher score indicating higher levels of experienced stress,

  20. The Perceived stress scale (PSS-10)

    Time frame: 5 months from baseline

    Measures levels of perceived stress, score ranging from 0 to 40, with a higher score indicating higher levels of experienced stress,

  21. The Perceived stress scale (PSS-10)

    Time frame: 8 months from baseline

    Measures levels of perceived stress, score ranging from 0 to 40, with a higher score indicating higher levels of experienced stress,

  22. Treatment Credibility Scale (TCS)

    Time frame: Will be measured 2 weeks from baseline

    Measures treatment credibility, scoring ranging between 0-50, with a higher score indicating higher levels of positive treatment expectations.

  23. 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').

Sponsors and collaborators

Lead sponsor

Karolinska Institutet

Other

Collaborators

  • Karolinska University Hospital

Registry information

Official study title

Cognitive Behavior Therapy for Patients With Premature Ventricular Contractions - a Pilot Study

Acronym: PVC-CBT

Important dates

Study start
2021
Primary completion
2021
Study completion
2022
First posted
Oct 21, 2021
Registry last updated
Aug 23, 2022

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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