PVC-CBT: CBT for Premature Ventricular Contractions
Study Details
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).
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
N/A |
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.
Study Design
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Other: PVC-specific CBT 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
Cognitive Behavior Therapy for PVC-specific anxiety education, in-vivo exposure, interoceptive exposure, behavioral activation, relapse prevention
|
Outcome Measures
Primary Outcome Measures
- Premature Ventricular Contractions effect on Quality-of-life (PVCEQT) [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)
- Premature Ventricular Contractions effect on Quality-of-life (PVCEQT) [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)
- Premature Ventricular Contractions effect on Quality-of-life (PVCEQT) [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)
- Premature Ventricular Contractions effect on Quality-of-life (PVCEQT) [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 Outcome Measures
- 12-Item Short-Form Health Survey (SF-12) [baseline]
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) [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.
- 12-Item Short-Form Health Survey (SF-12) [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.
- 12-Item Short-Form Health Survey (SF-12) [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.
- Symptom Checklist (SCL) [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
- Symptom Checklist (SCL) [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
- Symptom Checklist (SCL) [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
- Symptom Checklist (SCL) [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
- Arrhythmia burden [baseline]
Number of premature ventricular contractions per 24 hours is assessed by 5-day ECG Holter-monitoring
- Arrhythmia burden [10 weeks from baseline]
Number of premature ventricular contractions per 24 hours is assessed by 5-day ECG Holter-monitoring
- Arrhythmia burden [8 months from baseline]
Number of premature ventricular contractions per 24 hours is assessed by 5-day ECG Holter-monitoring
- Cardiac anxiety questionnaire (CAQ) [baseline]
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) [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.
- Cardiac anxiety questionnaire (CAQ) [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.
- Cardiac anxiety questionnaire (CAQ) [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 Outcome Measures
- Patient Health Questionnaire-9 (PHQ-9) [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.
- Patient Health Questionnaire-9 (PHQ-9) [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.
- Patient Health Questionnaire-9 (PHQ-9) [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.
- Patient Health Questionnaire-9 (PHQ-9) [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.
- Generalized Anxiety Disorder 7-item (GAD-7) [baseline]
General anxiety, score ranging from 0-21, with a higher score indicating more anxiety and worry.
- Generalized Anxiety Disorder 7-item (GAD-7) [10 weeks from baseline]
General anxiety, score ranging from 0-21, with a higher score indicating more anxiety and worry.
- Generalized Anxiety Disorder 7-item (GAD-7) [5 months from baseline]
General anxiety, score ranging from 0-21, with a higher score indicating more anxiety and worry.
- Generalized Anxiety Disorder 7-item (GAD-7) [8 months from baseline]
General anxiety, score ranging from 0-21, with a higher score indicating more anxiety and worry.
- Godin Shepard Leisure-time Physical Activity Questionnaire (GSLTPAQ) [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.
- Godin Shepard Leisure-time Physical Activity Questionnaire (GSLTPAQ) [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.
- Godin Shepard Leisure-time Physical Activity Questionnaire (GSLTPAQ) [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.
- Godin Shepard Leisure-time Physical Activity Questionnaire (GSLTPAQ) [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.
- Body Sensation Questionnaire (BSQ) [baseline]
Measures fear of bodily symptoms, score ranging from 0 to 72 . Higher scores indicate more fear of body sensations.
- Body Sensation Questionnaire (BSQ) [10 weeks from baseline]
Measures fear of bodily symptoms, score ranging from 0 to 72 . Higher scores indicate more fear of body sensations.
- Body Sensation Questionnaire (BSQ) [5 months from baseline]
Measures fear of bodily symptoms, score ranging from 0 to 72 . Higher scores indicate more fear of body sensations.
- Body Sensation Questionnaire (BSQ) [8 months from baseline]
Measures fear of bodily symptoms, score ranging from 0 to 72 . Higher scores indicate more fear of body sensations.
- Client satisfaction Questionnaire (CSQ) [10 weeks from baseline]
Measures treatment satisfaction, score ranging from 0 to 32, with a higher score indication more satisfaction with the treatment.
- The Perceived stress scale (PSS-10) [baseline]
Measures levels of perceived stress, score ranging from 0 to 40, with a higher score indicating higher levels of experienced stress,
- The Perceived stress scale (PSS-10) [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,
- The Perceived stress scale (PSS-10) [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,
- The Perceived stress scale (PSS-10) [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,
- Treatment Credibility Scale (TCS) [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.
- Adverse events [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').
Eligibility Criteria
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.
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Karolinska University Hospital | Stockholm | Sweden |
Sponsors and Collaborators
- Karolinska Institutet
- Karolinska University Hospital
Investigators
- Principal Investigator: Frieder Braunschweig, Karolinska
Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- PVC-CBT