CBT for Premature Ventricular Contractions

Ventricular Premature Complexes Clinical Trial

— PVC-CBT  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05087238
• Other study ID #: PVC-CBT
• Status: Completed
• Phase: N/A
• Start date: January 14, 2021
• Est. completion date: May 10, 2022

Study information

• Verified date: August 2022
• Source: Karolinska Institutet
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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).

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 19
• Est. completion date: May 10, 2022
• Est. primary completion date: November 5, 2021
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 70 Years

Eligibility

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.

Related Conditions & MeSH terms

• Premature Birth
• Ventricular Premature Complexes

Intervention

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

Locations

Country	Name	City	State
Sweden	Karolinska University Hospital	Stockholm

Sponsors (2)

Lead Sponsor	Collaborator
Karolinska Institutet	Karolinska University Hospital

Country where clinical trial is conducted

Sweden, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	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
Other	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.	10 weeks from baseline
Other	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
Other	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
Other	Generalized Anxiety Disorder 7-item (GAD-7)	General anxiety, score ranging from 0-21, with a higher score indicating more anxiety and worry.	baseline
Other	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
Other	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
Other	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
Other	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
Other	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
Other	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
Other	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
Other	Body Sensation Questionnaire (BSQ)	Measures fear of bodily symptoms, score ranging from 0 to 72 . Higher scores indicate more fear of body sensations.	baseline
Other	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
Other	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
Other	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
Other	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
Other	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
Other	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
Other	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
Other	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
Other	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
Other	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
Primary	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
Primary	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
Primary	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
Primary	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	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	Arrhythmia burden	Number of premature ventricular contractions per 24 hours is assessed by 5-day ECG Holter-monitoring	baseline
Secondary	Arrhythmia burden	Number of premature ventricular contractions per 24 hours is assessed by 5-day ECG Holter-monitoring	10 weeks from baseline
Secondary	Arrhythmia burden	Number of premature ventricular contractions per 24 hours is assessed by 5-day ECG Holter-monitoring	8 months from baseline
Secondary	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
Secondary	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
Secondary	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
Secondary	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