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| Name | Class |
|---|---|
| Karolinska University Hospital | OTHER |
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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).
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| PVC-specific CBT | Other | 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. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| CBT | Behavioral | Cognitive Behavior Therapy for PVC-specific anxiety education, in-vivo exposure, interoceptive exposure, behavioral activation, relapse prevention |
|
| 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 |
| 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) |
| Measure | Description | Time Frame |
|---|---|---|
| Patient Health Questionnaire-9 (PHQ-9) | 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. | baseline |
| Patient Health Questionnaire-9 (PHQ-9) |
Inclusion
Exclusion
All patients will undergo thorough cardiological and psychological assessment to ensure that eligibility criteria are met.
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| Name | Affiliation | Role |
|---|---|---|
| Frieder Braunschweig | Karolinska | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Karolinska University Hospital | Stockholm | Sweden |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 38713500 | Derived | Liliequist BE, Sarnholm J, Skuladottir H, Olafsdottir E, Ljotsson B, Braunschweig F. Cognitive Behavioral Therapy for Symptom Preoccupation Among Patients With Premature Ventricular Contractions: Nonrandomized Pretest-Posttest Study. JMIR Cardio. 2024 May 7;8:e53815. doi: 10.2196/53815. |
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| ID | Term |
|---|---|
| D018879 | Ventricular Premature Complexes |
| ID | Term |
|---|---|
| D005117 | Cardiac Complexes, Premature |
| D001145 | Arrhythmias, Cardiac |
| D006331 | Heart Diseases |
| D002318 | Cardiovascular Diseases |
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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 |
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.
| 10 weeks from baseline |
| Patient Health Questionnaire-9 (PHQ-9) | 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 months from baseline |
| Patient Health Questionnaire-9 (PHQ-9) | The PHQ-9 is a well-established measure of depression, score ranging 0 to 27 with a higher score indicating higher level of depression. | 8 months from baseline |
| Generalized Anxiety Disorder 7-item (GAD-7) | General anxiety, score ranging from 0-21, with a higher score indicating more anxiety and worry. | baseline |
| Generalized Anxiety Disorder 7-item (GAD-7) | General anxiety, score ranging from 0-21, with a higher score indicating more anxiety and worry. | 10 weeks from baseline |
| Generalized Anxiety Disorder 7-item (GAD-7) | General anxiety, score ranging from 0-21, with a higher score indicating more anxiety and worry. | 5 months from baseline |
| Generalized Anxiety Disorder 7-item (GAD-7) | General anxiety, score ranging from 0-21, with a higher score indicating more anxiety and worry. | 8 months from baseline |
| Godin Shepard Leisure-time Physical Activity Questionnaire (GSLTPAQ) | 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. | baseline |
| Godin Shepard Leisure-time Physical Activity Questionnaire (GSLTPAQ) | 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 weeks from baseline |
| Godin Shepard Leisure-time Physical Activity Questionnaire (GSLTPAQ) | 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. | 5 months from baseline |
| Godin Shepard Leisure-time Physical Activity Questionnaire (GSLTPAQ) | 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. | 8 months from baseline |
| Body Sensation Questionnaire (BSQ) | Measures fear of bodily symptoms, score ranging from 0 to 72 . Higher scores indicate more fear of body sensations. | baseline |
| Body Sensation Questionnaire (BSQ) | Measures fear of bodily symptoms, score ranging from 0 to 72 . Higher scores indicate more fear of body sensations. | 10 weeks from baseline |
| Body Sensation Questionnaire (BSQ) | Measures fear of bodily symptoms, score ranging from 0 to 72 . Higher scores indicate more fear of body sensations. | 5 months from baseline |
| Body Sensation Questionnaire (BSQ) | Measures fear of bodily symptoms, score ranging from 0 to 72 . Higher scores indicate more fear of body sensations. | 8 months from baseline |
| Client satisfaction Questionnaire (CSQ) | Measures treatment satisfaction, score ranging from 0 to 32, with a higher score indication more satisfaction with the treatment. | 10 weeks from baseline |
| The Perceived stress scale (PSS-10) | Measures levels of perceived stress, score ranging from 0 to 40, with a higher score indicating higher levels of experienced stress, | baseline |
| The Perceived stress scale (PSS-10) | Measures levels of perceived stress, score ranging from 0 to 40, with a higher score indicating higher levels of experienced stress, | 10 weeks from baseline |
| The Perceived stress scale (PSS-10) | Measures levels of perceived stress, score ranging from 0 to 40, with a higher score indicating higher levels of experienced stress, | 5 months from baseline |
| The Perceived stress scale (PSS-10) | Measures levels of perceived stress, score ranging from 0 to 40, with a higher score indicating higher levels of experienced stress, | 8 months from baseline |
| Treatment Credibility Scale (TCS) | Measures treatment credibility, scoring ranging between 0-50, with a higher score indicating higher levels of positive treatment expectations. | Will be measured 2 weeks from baseline |
| Adverse events | 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'). | 10 weeks from baseline |
| D000075224 | Cardiac Conduction System Disease |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |