CBT for Premature Ventricular Contractions (PVC-CBT)

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

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).

Study Overview

• Status: Completed
• Conditions: Ventricular Premature Complexes
• Intervention / Treatment: Behavioral: CBT

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 Type: Interventional
• Enrollment (Actual): 19
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Sweden
  • Stockholm, Sweden
    • Karolinska University Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 70 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / 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

What is the study measuring?

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.	8 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.	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
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

Other Outcome Measures

Outcome Measure	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)	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

Collaborators and Investigators

• Sponsor: Karolinska Institutet
• Collaborators: Karolinska University Hospital
• Investigators: Principal Investigator: Frieder Braunschweig, Karolinska

Study record dates

Study Major Dates

• Study Start (Actual): January 14, 2021
• Primary Completion (Actual): November 5, 2021
• Study Completion (Actual): May 10, 2022

Study Registration Dates

• First Submitted: June 24, 2021
• First Submitted That Met QC Criteria: October 8, 2021
• First Posted (Actual): October 21, 2021

Study Record Updates

• Last Update Posted (Actual): August 23, 2022
• Last Update Submitted That Met QC Criteria: August 22, 2022
• Last Verified: August 1, 2022

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pathologic Processes; Heart Diseases; Cardiovascular Diseases; Arrhythmias, Cardiac; Cardiac Conduction System Disease; Pregnancy Complications; Obstetric Labor Complications; Obstetric Labor, Premature; Cardiac Complexes, Premature; Premature Birth; Ventricular Premature Complexes
• Other Study ID Numbers: PVC-CBT

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No