CBT for Premature Ventricular Contractions

Study Overview
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Brief Summary
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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).

Detailed Description
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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.

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

Conditions
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Ventricular Premature Complexes

Intervention / Treatment
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* Behavioral: CBT


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 70 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Other: PVC-specific CBT<br>This novel CBT treatment for symptomatic PVC targets cardiac anxiety and symptom preoccupation related to PVC. Treatment is developed from the research groups treatment for Atrial Fibrillation and may be altered during the treatment period to better meet the needs of the patients. Patients receive 10 weeks of CBT delivered through face to face digital video sessions. | Behavioral: CBT<br>* Cognitive Behavior Therapy for PVC-specific anxiety education, in-vivo exposure, interoceptive exposure, behavioral activation, relapse prevention<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Premature Ventricular Contractions effect on Quality-of-life (PVCEQT) | 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) | baseline | 
| Premature Ventricular Contractions effect on Quality-of-life (PVCEQT) | 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) | 10 weeks from baseline | 
| Premature Ventricular Contractions effect on Quality-of-life (PVCEQT) | 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) | 5 months from baseline | 
| Premature Ventricular Contractions effect on Quality-of-life (PVCEQT) | 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) | 8 months from baseline | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 12-Item Short-Form Health Survey (SF-12) | General quality of life, with a score ranging from 0 to 100. A higher score indicating a better quality of life. | baseline | 
| 12-Item Short-Form Health Survey (SF-12) | General quality of life, with a score ranging from 0 to 100. A higher score indicating a better quality of life. | 10 weeks from baseline | 
| 12-Item Short-Form Health Survey (SF-12) | General quality of life, with a score ranging from 0 to 100. A higher score indicating a better quality of life. | 5 months from baseline | 
| 12-Item Short-Form Health Survey (SF-12) | General quality of life, with a score ranging from 0 to 100. A higher score indicating a better quality of life. | 8 months from baseline | 
| Symptom Checklist (SCL) | 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 | baseline | 
| Symptom Checklist (SCL) | 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 | 10 weeks from baseline | 
| Symptom Checklist (SCL) | 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 | 5 months from baseline | 
| Symptom Checklist (SCL) | 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 months from baseline | 
| Arrhythmia burden | Number of premature ventricular contractions per 24 hours is assessed by 5-day ECG Holter-monitoring | baseline | 
| Arrhythmia burden | Number of premature ventricular contractions per 24 hours is assessed by 5-day ECG Holter-monitoring | 10 weeks from baseline | 
| Arrhythmia burden | Number of premature ventricular contractions per 24 hours is assessed by 5-day ECG Holter-monitoring | 8 months from baseline | 
| Cardiac anxiety questionnaire (CAQ) | Measure of cardiac anxiety, fear, avoidance and attention. The score ranges between 0 and 72, with a greater score indicating elevated cardiac anxiety. | baseline | 
| Cardiac anxiety questionnaire (CAQ) | Measure of cardiac anxiety, fear, avoidance and attention. The score ranges between 0 and 72, with a greater score indicating elevated cardiac anxiety. | 10 weeks from baseline | 
| Cardiac anxiety questionnaire (CAQ) | Measure of cardiac anxiety, fear, avoidance and attention. The score ranges between 0 and 72, with a greater score indicating elevated cardiac anxiety. | 5 months from baseline | 
| Cardiac anxiety questionnaire (CAQ) | Measure of cardiac anxiety, fear, avoidance and attention. The score ranges between 0 and 72, with a greater score indicating elevated cardiac anxiety. | 8 months from baseline |