Back to resultsCBT for Premature Ventricular Contractions (PVC-CBT)
Primary Purpose
Ventricular Premature Complexes
Status
Completed
Phase
Not Applicable
Locations
Sweden
Study Type
Interventional
Intervention
CBT
Sponsored by
About this trial
This is an interventional treatment trial for Ventricular Premature Complexes
Eligibility Criteria
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.
Sites / Locations
- Karolinska University Hospital
Arms of the Study
Arm 1
Arm Type
Other
Arm Label
PVC-specific CBT
Arm Description
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.
Outcomes
Primary Outcome Measures
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)
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)
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)
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)
Secondary Outcome Measures
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.
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.
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.
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.
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
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
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
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
Arrhythmia burden
Number of premature ventricular contractions per 24 hours is assessed by 5-day ECG Holter-monitoring
Arrhythmia burden
Number of premature ventricular contractions per 24 hours is assessed by 5-day ECG Holter-monitoring
Arrhythmia burden
Number of premature ventricular contractions per 24 hours is assessed by 5-day ECG Holter-monitoring
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.
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.
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.
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.
Full Information
NCT ID
NCT05087238
First Posted
June 24, 2021
Last Updated
August 22, 2022
Sponsor
Karolinska Institutet
Collaborators
Karolinska University Hospital
1. Study Identification
Unique Protocol Identification Number
NCT05087238
Brief Title
CBT for Premature Ventricular Contractions
Acronym
PVC-CBT
Official Title
Cognitive Behavior Therapy for Patients With Premature Ventricular Contractions - a Pilot Study
Study Type
Interventional
2. Study Status
Record Verification Date
August 2022
Overall Recruitment Status
Completed
Study Start Date
January 14, 2021 (Actual)
Primary Completion Date
November 5, 2021 (Actual)
Study Completion Date
May 10, 2022 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Karolinska Institutet
Collaborators
Karolinska University Hospital
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
5. Study Description
Brief Summary
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
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Ventricular Premature Complexes
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
19 (Actual)
8. Arms, Groups, and Interventions
Arm Title
PVC-specific CBT
Arm Type
Other
Arm Description
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.
Intervention Type
Behavioral
Intervention Name(s)
CBT
Intervention Description
Cognitive Behavior Therapy for PVC-specific anxiety education, in-vivo exposure, interoceptive exposure, behavioral activation, relapse prevention
Primary Outcome Measure Information:
Title
Premature Ventricular Contractions effect on Quality-of-life (PVCEQT)
Description
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)
Time Frame
baseline
Title
Premature Ventricular Contractions effect on Quality-of-life (PVCEQT)
Description
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)
Time Frame
10 weeks from baseline
Title
Premature Ventricular Contractions effect on Quality-of-life (PVCEQT)
Description
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)
Time Frame
5 months from baseline
Title
Premature Ventricular Contractions effect on Quality-of-life (PVCEQT)
Description
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)
Time Frame
8 months from baseline
Secondary Outcome Measure Information:
Title
12-Item Short-Form Health Survey (SF-12)
Description
General quality of life, with a score ranging from 0 to 100. A higher score indicating a better quality of life.
Time Frame
baseline
Title
12-Item Short-Form Health Survey (SF-12)
Description
General quality of life, with a score ranging from 0 to 100. A higher score indicating a better quality of life.
Time Frame
10 weeks from baseline
Title
12-Item Short-Form Health Survey (SF-12)
Description
General quality of life, with a score ranging from 0 to 100. A higher score indicating a better quality of life.
Time Frame
5 months from baseline
Title
12-Item Short-Form Health Survey (SF-12)
Description
General quality of life, with a score ranging from 0 to 100. A higher score indicating a better quality of life.
Time Frame
8 months from baseline
Title
Symptom Checklist (SCL)
Description
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
Time Frame
baseline
Title
Symptom Checklist (SCL)
Description
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
Time Frame
10 weeks from baseline
Title
Symptom Checklist (SCL)
Description
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
Time Frame
5 months from baseline
Title
Symptom Checklist (SCL)
Description
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
Time Frame
8 months from baseline
Title
Arrhythmia burden
Description
Number of premature ventricular contractions per 24 hours is assessed by 5-day ECG Holter-monitoring
Time Frame
baseline
Title
Arrhythmia burden
Description
Number of premature ventricular contractions per 24 hours is assessed by 5-day ECG Holter-monitoring
Time Frame
10 weeks from baseline
Title
Arrhythmia burden
Description
Number of premature ventricular contractions per 24 hours is assessed by 5-day ECG Holter-monitoring
Time Frame
8 months from baseline
Title
Cardiac anxiety questionnaire (CAQ)
Description
Measure of cardiac anxiety, fear, avoidance and attention. The score ranges between 0 and 72, with a greater score indicating elevated cardiac anxiety.
Time Frame
baseline
Title
Cardiac anxiety questionnaire (CAQ)
Description
Measure of cardiac anxiety, fear, avoidance and attention. The score ranges between 0 and 72, with a greater score indicating elevated cardiac anxiety.
Time Frame
10 weeks from baseline
Title
Cardiac anxiety questionnaire (CAQ)
Description
Measure of cardiac anxiety, fear, avoidance and attention. The score ranges between 0 and 72, with a greater score indicating elevated cardiac anxiety.
Time Frame
5 months from baseline
Title
Cardiac anxiety questionnaire (CAQ)
Description
Measure of cardiac anxiety, fear, avoidance and attention. The score ranges between 0 and 72, with a greater score indicating elevated cardiac anxiety.
Time Frame
8 months from baseline
Other Pre-specified Outcome Measures:
Title
Patient Health Questionnaire-9 (PHQ-9)
Description
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.
Time Frame
baseline
Title
Patient Health Questionnaire-9 (PHQ-9)
Description
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.
Time Frame
10 weeks from baseline
Title
Patient Health Questionnaire-9 (PHQ-9)
Description
The PHQ-9 is a well-established measure of depression, score ranging 0 to 27 with a higher score indicating higher level of depression.
Time Frame
5 months from baseline
Title
Patient Health Questionnaire-9 (PHQ-9)
Description
The PHQ-9 is a well-established measure of depression, score ranging 0 to 27 with a higher score indicating higher level of depression.
Time Frame
8 months from baseline
Title
Generalized Anxiety Disorder 7-item (GAD-7)
Description
General anxiety, score ranging from 0-21, with a higher score indicating more anxiety and worry.
Time Frame
baseline
Title
Generalized Anxiety Disorder 7-item (GAD-7)
Description
General anxiety, score ranging from 0-21, with a higher score indicating more anxiety and worry.
Time Frame
10 weeks from baseline
Title
Generalized Anxiety Disorder 7-item (GAD-7)
Description
General anxiety, score ranging from 0-21, with a higher score indicating more anxiety and worry.
Time Frame
5 months from baseline
Title
Generalized Anxiety Disorder 7-item (GAD-7)
Description
General anxiety, score ranging from 0-21, with a higher score indicating more anxiety and worry.
Time Frame
8 months from baseline
Title
Godin Shepard Leisure-time Physical Activity Questionnaire (GSLTPAQ)
Description
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.
Time Frame
baseline
Title
Godin Shepard Leisure-time Physical Activity Questionnaire (GSLTPAQ)
Description
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.
Time Frame
10 weeks from baseline
Title
Godin Shepard Leisure-time Physical Activity Questionnaire (GSLTPAQ)
Description
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.
Time Frame
5 months from baseline
Title
Godin Shepard Leisure-time Physical Activity Questionnaire (GSLTPAQ)
Description
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.
Time Frame
8 months from baseline
Title
Body Sensation Questionnaire (BSQ)
Description
Measures fear of bodily symptoms, score ranging from 0 to 72 . Higher scores indicate more fear of body sensations.
Time Frame
baseline
Title
Body Sensation Questionnaire (BSQ)
Description
Measures fear of bodily symptoms, score ranging from 0 to 72 . Higher scores indicate more fear of body sensations.
Time Frame
10 weeks from baseline
Title
Body Sensation Questionnaire (BSQ)
Description
Measures fear of bodily symptoms, score ranging from 0 to 72 . Higher scores indicate more fear of body sensations.
Time Frame
5 months from baseline
Title
Body Sensation Questionnaire (BSQ)
Description
Measures fear of bodily symptoms, score ranging from 0 to 72 . Higher scores indicate more fear of body sensations.
Time Frame
8 months from baseline
Title
Client satisfaction Questionnaire (CSQ)
Description
Measures treatment satisfaction, score ranging from 0 to 32, with a higher score indication more satisfaction with the treatment.
Time Frame
10 weeks from baseline
Title
The Perceived stress scale (PSS-10)
Description
Measures levels of perceived stress, score ranging from 0 to 40, with a higher score indicating higher levels of experienced stress,
Time Frame
baseline
Title
The Perceived stress scale (PSS-10)
Description
Measures levels of perceived stress, score ranging from 0 to 40, with a higher score indicating higher levels of experienced stress,
Time Frame
10 weeks from baseline
Title
The Perceived stress scale (PSS-10)
Description
Measures levels of perceived stress, score ranging from 0 to 40, with a higher score indicating higher levels of experienced stress,
Time Frame
5 months from baseline
Title
The Perceived stress scale (PSS-10)
Description
Measures levels of perceived stress, score ranging from 0 to 40, with a higher score indicating higher levels of experienced stress,
Time Frame
8 months from baseline
Title
Treatment Credibility Scale (TCS)
Description
Measures treatment credibility, scoring ranging between 0-50, with a higher score indicating higher levels of positive treatment expectations.
Time Frame
Will be measured 2 weeks from baseline
Title
Adverse events
Description
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').
Time Frame
10 weeks from baseline
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Frieder Braunschweig
Organizational Affiliation
Karolinska
Official's Role
Principal Investigator
Facility Information:
Facility Name
Karolinska University Hospital
City
Stockholm
Country
Sweden
12. IPD Sharing Statement
Learn more about this trial
CBT for Premature Ventricular Contractions
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